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Randomiseret, indlejret, multifaktoriel adaptiv platformsprøve for lungebetændelse i lokalsamfundet (REMAP-CAP)

30. oktober 2026 opdateret af: Lennie Derde, UMC Utrecht

REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of hospitalised patients admitted to intensive care with respiratory tract infections.

In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background: Respiratory tract infections that are of sufficient severity to require admission to hospital are associated with substantial mortality. All hospitalized patients with respiratory tract infections will receive therapy that consists of a combination of multiple different treatments. For many of these treatments, different options are available currently. For example, several antibiotics exist that are active against the microorganisms that commonly cause pneumonia but it is not known if one antibiotic strategy is best, or whether all suitable antibiotic strategies have similar levels of effectiveness. Of all the treatments that clinicians use for patients with respiratory tract infections, only a small minority have been tested in randomized controlled trials to determine their comparative effectiveness. As a consequence, the standard treatments that are administered vary between and within countries. Current conventional clinical trials methods to assess the efficacy of treatments for respiratory tract infections generally compare two treatment options (either two options for the same treatment modality, where both are in common use; or a new treatment against no treatment or placebo, where the effectiveness of the new treatment is not known). Using this approach, in a series of separate and sequential trials, it will take an inordinate length of time to study all the treatment options. Additionally, with conventional trial designs it is not possible to evaluate interactions between treatment options.

Aim: The primary objective of this platform trial is, for patients hospitalized with respiratory tract infection, to identify the effect of a range of interventions to improve patient outcomes.

Methods: The study will enroll hospitalized patients with respiratory tract infection using a trial design known as a REMAP, which is a type of platform trial. Within this platform trial, eligible participants will be randomized to receive one intervention in each of one or more domains. The primary outcome is a composite of 90-day all-cause mortality and, among survivors, a daily ordinal scale analyzed as a trajectory of illness and recovery to 28-days. There will also be both Platform and domain-specific secondary outcome measures.

In a conventional trial enrollment continues until a pre-specified sample size is obtained, at which time enrollment ceases and the trial data are analyzed to obtain a result. The possible results are that a difference is detected, or no that no difference is detected. However, when the conclusion of the statistical test is "no difference", this could reflect that there truly is no meaningful difference or that the result is indeterminate (i.e., it is possible that if more patients had been enrolled a clinically relevant difference may have been detected).

In comparison to a conventional trial this Platform uses an adaptive design that:

  • avoids indeterminate results by concluding an answer to a question when sufficient data have accrued (not when a pre-specified sample is reached);
  • utilizes already accrued data to increase the likelihood that patients within the trial are more likely to be randomized to treatments that are more likely to be beneficial;
  • is intended to be perpetual (or at least open-ended), substituting new questions in series as initial questions are answered; and
  • can evaluate the interaction between interventions in different domains, added at different timepoints into the Platform.

Bayesian statistical methods will be used to define Statistical Triggers that reflect thresholds for decision making within a domain. While a limited number of initial treatments and treatment domains were specified at initiation, other interventions and domains have been evaluated over time, and it is planned that this platform trial will continue to evaluate other treatments in the future. Furthermore, in the event of a future epidemic, this Platform is able to adapt to evaluate the most relevant treatment options.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20000

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australien, 2605
        • Rekruttering
        • Canberra Hospital
    • New South Wales
      • Bankstown, New South Wales, Australien, 2200
        • Rekruttering
        • Bankstown-Lidcombe Hospital
      • Blacktown, New South Wales, Australien, 2148
        • Rekruttering
        • Blacktown Hospital
      • Campbelltown, New South Wales, Australien, 2560
        • Rekruttering
        • Campbelltown Hospital
      • Caringbah, New South Wales, Australien, 2229
        • Rekruttering
        • Sutherland Hospital
      • Concord, New South Wales, Australien, 2139
        • Rekruttering
        • Concord Hospital
      • Dubbo, New South Wales, Australien, 2830
        • Rekruttering
        • Dubbo Base Hospital
      • Frenchs Forest, New South Wales, Australien, 2086
        • Rekruttering
        • Northern Beaches Hospital
      • Kingswood, New South Wales, Australien, 2750
        • Rekruttering
        • Nepean Hospital
      • Kogarah, New South Wales, Australien, 2217
        • Rekruttering
        • St. George Hospital
      • Liverpool, New South Wales, Australien, 2170
        • Rekruttering
        • Liverpool Hospital
      • Newcastle, New South Wales, Australien, 2305
        • Rekruttering
        • John Hunter Hospital
      • Orange, New South Wales, Australien, 2800
        • Ikke rekrutterer endnu
        • Orange Health Service
      • Sydney, New South Wales, Australien, 2065
        • Rekruttering
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australien, 2010
        • Rekruttering
        • St Vincent's Hospital Sydney
      • Sydney, New South Wales, Australien, 2031
        • Rekruttering
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australien, 2050
        • Ikke rekrutterer endnu
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australien, 2500
        • Rekruttering
        • Wollongong Hospital
      • Wagga Wagga, New South Wales, Australien, 2650
        • Ikke rekrutterer endnu
        • Wagga Wagga Base Hospital
      • Westmead, New South Wales, Australien, 2145
        • Rekruttering
        • Westmead Hospital
    • Northern Territory
      • Darwin, Northern Territory, Australien, 0810
        • Ikke rekrutterer endnu
        • Royal Darwin Hospital,
    • Queensland
      • Birtinya, Queensland, Australien, 4575
        • Ikke rekrutterer endnu
        • Sunshine Coast University Hospital
      • Brisbane, Queensland, Australien, 4102
        • Rekruttering
        • Princess Alexandra Hospital
      • Brisbane, Queensland, Australien, 4032
        • Rekruttering
        • The Prince Charles Hospital
      • Brisbane, Queensland, Australien, 4101
        • Rekruttering
        • Mater Hospital Brisbane
      • Caboolture, Queensland, Australien, 4510
        • Rekruttering
        • Caboolture Hospital
      • Coopers Plains, Queensland, Australien, 4110
        • Rekruttering
        • Queen Elizabeth II Jubilee Hospital
      • Logan City, Queensland, Australien, 4129
        • Ikke rekrutterer endnu
        • Logan Hospital
      • Redcliffe, Queensland, Australien, 4020
        • Ikke rekrutterer endnu
        • Redcliffe Hospital
      • Rockhampton, Queensland, Australien, 4700
        • Ikke rekrutterer endnu
        • Rockhampton Hospital
      • Southport, Queensland, Australien, 4215
        • Rekruttering
        • Gold Coast University Hospital
      • Toowoomba, Queensland, Australien, 4350
        • Rekruttering
        • Toowoomba Hospital
      • Townsville, Queensland, Australien, 4814
        • Rekruttering
        • Townsville Hospital
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Rekruttering
        • Royal Adelaide Hospital
      • Adelaide, South Australia, Australien, 5011
        • Rekruttering
        • The Queen Elizabeth Hospital
      • Adelaide, South Australia, Australien, 5112
        • Rekruttering
        • Lyell McEwin Hospital
      • Bedford Park, South Australia, Australien, 5042
        • Rekruttering
        • Flinders Medical Centre
    • Tasmania
      • Launceston, Tasmania, Australien, 7250
        • Rekruttering
        • Launceston Hospital
    • Victoria
      • Ballarat, Victoria, Australien, 3350
        • Rekruttering
        • Ballarat Base Hospital
      • Bendigo, Victoria, Australien, 3550
        • Rekruttering
        • Bendigo Hospital
      • Berwick, Victoria, Australien, 3806
        • Rekruttering
        • Casey Hospital
      • Box Hill, Victoria, Australien, 3128
        • Rekruttering
        • Box Hill Hospital
      • Clayton, Victoria, Australien, 3168
        • Rekruttering
        • Monash Medical Centre
      • Dandenong, Victoria, Australien, 3175
        • Rekruttering
        • Dandenong Hospital
      • Ferntree Gully, Victoria, Australien, 3156
        • Ikke rekrutterer endnu
        • Angliss Hospital
      • Footscray, Victoria, Australien, 3011
        • Rekruttering
        • Footscray Hospital
      • Geelong, Victoria, Australien, 3220
        • Rekruttering
        • University Hosptial Geelong
      • Melbourne, Victoria, Australien, 3004
        • Rekruttering
        • The Alfred Hospital
      • Melbourne, Victoria, Australien, 3050
        • Rekruttering
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australien, 3065
        • Rekruttering
        • St Vincent's Hospital Melbourne
      • Ringwood East, Victoria, Australien, 3135
        • Rekruttering
        • Maroondah Hospital
      • Sunshine, Victoria, Australien, 3021
        • Rekruttering
        • Sunshine Hospital
      • Werribee, Victoria, Australien, 3030
        • Rekruttering
        • Werribee Mercy Hospital
    • Western Australia
      • Midland, Western Australia, Australien, 6056
        • Rekruttering
        • St John of God Hospital Midland
      • Murdoch, Western Australia, Australien, 6150
        • Ikke rekrutterer endnu
        • St John of God Hospital Murdoch
      • Perth, Western Australia, Australien, 6000
        • Rekruttering
        • Royal Perth Hospital
      • Perth, Western Australia, Australien, 6150
        • Rekruttering
        • Fiona Stanley Hospital
      • Perth, Western Australia, Australien, 6009
        • Rekruttering
        • Sir Charles Gairdner Hospital
      • Subiaco, Western Australia, Australien, 6008
        • Rekruttering
        • St John of God Subiaco
      • Charleroi, Belgien, 6042
        • Rekruttering
        • CHU de Charleroi - Hôpital Civil Marie Curie
        • Kontakt:
          • Patrick Biston, MD
      • Ghent, Belgien, 9000
        • Rekruttering
        • Universitair Ziekenhuis Gent
        • Kontakt:
          • Pieter Depuydt, Prof.
      • Namur, Belgien, 5530
        • Rekruttering
        • CHU Namur site Godinne
        • Kontakt:
          • Pierre Bulpa, MD
    • Alberta
      • Calgary, Alberta, Canada, T2W 1S7
        • Aktiv, ikke rekrutterende
        • Foothills Medical Centre
      • Calgary, Alberta, Canada, T2W 1S7
        • Aktiv, ikke rekrutterende
        • Peter Lougheed Centre
      • Calgary, Alberta, Canada, T2W 1S7
        • Aktiv, ikke rekrutterende
        • Rockyview General Hospital
      • Calgary, Alberta, Canada, T2W 1S7
        • Aktiv, ikke rekrutterende
        • South Health Campus
      • Edmonton, Alberta, Canada, T5H 3V9
        • Rekruttering
        • Royal Alexandra Hospital, Alberta
        • Kontakt:
          • Demetrios Kutsogiannis, MD
      • Edmonton, Alberta, Canada, T6G 2C8
        • Rekruttering
        • University of Alberta Hospital
        • Kontakt:
          • Wendy Sligl, MD
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Ikke rekrutterer endnu
        • Surrey Memorial Hospital
        • Kontakt:
          • Anish Mitra, MD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Rekruttering
        • Health Sciences Centre Winnipeg
        • Kontakt:
          • Ryan Zarychanski, MD
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Rekruttering
        • St Boniface General Hospital
        • Kontakt:
          • Ryan Zarychanski, MD
      • Winnipeg, Manitoba, Canada, R3J 3M7
        • Rekruttering
        • Grace Hospital
        • Kontakt:
          • Gloria Vazquez-Grande, MD
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 4R3
        • Ikke rekrutterer endnu
        • Dr. Everett Chalmers Regional Hospital
        • Kontakt:
          • Zeeshan Aslam, MD
      • Fredericton, New Brunswick, Canada, E3B 4R3
        • Ikke rekrutterer endnu
        • The Moncton Hospital
        • Kontakt:
          • Daniel Smyth, MD
      • Fredericton, New Brunswick, Canada, E3B 4R3
        • Ikke rekrutterer endnu
        • The Saint John General Hospital
        • Kontakt:
          • Stephen Robinson, MD
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Rekruttering
        • William Osler Health System
        • Kontakt:
          • Alexandra Binnie, MD
      • Brantford, Ontario, Canada, N3R 1G9
        • Rekruttering
        • Brantford General Hospital
        • Kontakt:
          • Brenda Reeve, MD
      • Hamilton, Ontario, Canada, L8N 4A6
        • Rekruttering
        • St. Joseph's Healthcare Hamilton
        • Kontakt:
          • Deborah Cook, MD
      • Hamilton, Ontario, Canada, L8L 8E7
        • Rekruttering
        • Juravinski Hospital
        • Kontakt:
          • Bram Rochwerg, MD
      • Hamilton, Ontario, Canada, L8L 8E7
        • Rekruttering
        • Hamilton general Hospital
        • Kontakt:
          • Alison Fox-Robichaud, MD
      • Kingston, Ontario, Canada, K7L 2V7
        • Aktiv, ikke rekrutterende
        • Kingston Health Sciences Centre
      • Kitchener, Ontario, Canada, N2G 4K9
        • Rekruttering
        • Grand River Hospital
        • Kontakt:
          • Theresa Liu, MD
      • Kitchener, Ontario, Canada, N2M 1B2
        • Rekruttering
        • St Mary's General Hospital
        • Kontakt:
          • Rebecca Kruisselbrink, MD
      • Ottawa, Ontario, Canada, K1H 8L6
        • Rekruttering
        • The Ottawa Hospital
        • Kontakt:
          • Lauralyn McIntyre, MD
      • Saint Catharines, Ontario, Canada, L2S 0A9
        • Rekruttering
        • Niagara Health
        • Kontakt:
          • Jennifer Tsang, MD
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Aktiv, ikke rekrutterende
        • Thunder Bay General Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Rekruttering
        • Toronto General Hospital
        • Kontakt:
          • Lorenzo del Sorbo, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Rekruttering
        • Sunnybrook Health Sciences Centre
        • Kontakt:
          • Rob Fowler, MD
      • Toronto, Ontario, Canada, M5T 2S8
        • Rekruttering
        • Toronto Western Hospital
        • Kontakt:
          • Elizabeth Wilcox, MD
      • Toronto, Ontario, Canada, M5G 1X5
        • Rekruttering
        • Mount Sinai Hospital
        • Kontakt:
          • Sangeeta Mehta, MD
      • Toronto, Ontario, Canada, M5B 1W8
        • Rekruttering
        • St. Michael's Hospital Unity Health Toronto
        • Kontakt:
          • John Marshall, MD
      • Toronto, Ontario, Canada, M6R 1B5
        • Aktiv, ikke rekrutterende
        • St Joseph's Health Centre
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Ikke rekrutterer endnu
        • CIUSS Chaudieres-Appalaches (Levis)
        • Kontakt:
          • Patrick Archambault, MD
      • Montreal, Quebec, Canada, H3H 2R9
        • Rekruttering
        • McGill University Health Centre
        • Kontakt:
          • Kosar Khwaja, MD
      • Montreal, Quebec, Canada, H2X 0A9
        • Rekruttering
        • Centre Hospitalier de l'Universite de Montreal
        • Kontakt:
          • Michael Chasse, MD
      • Montreal, Quebec, Canada, H1T 2M4
        • Aktiv, ikke rekrutterende
        • Hospital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H2B 1K3
        • Ikke rekrutterer endnu
        • Hôpital Fleury
        • Kontakt:
          • Thomas Hemmerling, MD
      • Montreal, Quebec, Canada, H4J 1C5
        • Rekruttering
        • Hopital du Sacre-Coeur de Montreal
        • Kontakt:
          • Martin Albert, MD
      • Québec, Quebec, Canada, G1V 4G5
        • Rekruttering
        • IUCPQ-UL
        • Kontakt:
          • Francois Lellouche, MD
      • Québec, Quebec, Canada, G1R 2J6
        • Rekruttering
        • CHU de Québec - Université Laval
        • Kontakt:
          • Alexis Turgeon, MD
      • Sherbrooke, Quebec, Canada, J1J 3H5
        • Rekruttering
        • Centre Hospitalier de l'Université de Sherbrooke
        • Kontakt:
          • Francois Lamontagne, MD
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0M7
        • Rekruttering
        • Regina General Hospital
        • Kontakt:
          • Eric Sy, MD
    • Cundinamarca
      • Chía, Cundinamarca, Colombia
        • Rekruttering
        • Universidad de La Sabana
      • Belfast, Det Forenede Kongerige, BT16 1RH
        • Rekruttering
        • Ulster Hospital
        • Kontakt:
          • Christopher Murray, MD
      • Bristol, Det Forenede Kongerige, BS2 8BJ
        • Rekruttering
        • Bristol Royal Childrens Hospital
        • Kontakt:
          • Jolanta Bernatoniene, MD
      • Bury, Det Forenede Kongerige, BL9 7TD
        • Rekruttering
        • Fairfield General Hospital
        • Kontakt:
          • Andrew Claxton, MD
      • Crewe, Det Forenede Kongerige, CW1 4QJ
        • Rekruttering
        • Leighton Hospital
        • Kontakt:
          • Richard Lowsby, MD
      • Dorchester, Det Forenede Kongerige, DT1 2JY
        • Afsluttet
        • Dorset County Hospital
      • Gloucester, Det Forenede Kongerige, GL1 3NN
        • Afsluttet
        • Gloucester Royal Hospital
      • Haywards Heath, Det Forenede Kongerige, RH16 4EX
        • Aktiv, ikke rekrutterende
        • The Princess Royal Hospital Haywards Heath
      • Leeds, Det Forenede Kongerige, LS9 7TF
        • Rekruttering
        • St. James University Hospital
        • Kontakt:
          • E Paramasivam, MD
      • London, Det Forenede Kongerige, NW1 2BU
        • Rekruttering
        • University College London Hospital
        • Kontakt:
          • Michael Marks, MD
      • London, Det Forenede Kongerige, SW10 9NH
        • Rekruttering
        • Chelsea and Westminster Hospital
        • Kontakt:
          • Roger Davies, MD
      • London, Det Forenede Kongerige, E9 6SR
        • Suspenderet
        • Homerton Hospital
      • Margate, Det Forenede Kongerige, CT9 4AN
        • Suspenderet
        • Queen Elizabeth and Queen Mother Hospital
      • Newcastle upon Tyne, Det Forenede Kongerige, NE1 4LP
        • Rekruttering
        • Newcastle Royal Victoria Infirmary (Paediatrics)
        • Kontakt:
          • Marieke Emonts, MD
      • North Shields, Det Forenede Kongerige, Ne29 8NH
        • Suspenderet
        • North Tyneside General Hospital
      • Warwick, Det Forenede Kongerige, CV34 5BW
        • Aktiv, ikke rekrutterende
        • Warwick Hospital
      • West Bromwich, Det Forenede Kongerige, B71 4HJ
        • Rekruttering
        • Sandwell General Hospital
        • Kontakt:
          • Jonathan Hulme, MD
    • England
      • Basildon, England, Det Forenede Kongerige, SS16 5NL
        • Aktiv, ikke rekrutterende
        • Basildon Hospital
      • Basingstoke, England, Det Forenede Kongerige, RG24 9NA
        • Rekruttering
        • Basingstoke and North Hampshire Hospital
        • Kontakt:
          • Irena Grecu, MD
      • Bath, England, Det Forenede Kongerige, BA1 3NG
        • Aktiv, ikke rekrutterende
        • Royal United Hospital, Bath
      • Birmingham, England, Det Forenede Kongerige, B15 2TH
        • Rekruttering
        • Queen Elizabeth Hospital Birmingham
        • Kontakt:
          • Dhruv Parekh
      • Birmingham, England, Det Forenede Kongerige, B18 7QH
        • Rekruttering
        • Birmingham City Hospital
        • Kontakt:
          • Jonathan Hulme
      • Blackburn, England, Det Forenede Kongerige, BB2 3HH
        • Rekruttering
        • Royal Blackburn Teaching Hospital
        • Kontakt:
          • Srikanth Chukkambotla, MD
      • Boston, England, Det Forenede Kongerige, PE21 9QS
        • Suspenderet
        • Pilgrim Hospital ULHT
      • Bournemouth, England, Det Forenede Kongerige, BH7 7DW
        • Aktiv, ikke rekrutterende
        • Royal Bournemouth Hospital
      • Brighton, England, Det Forenede Kongerige, BN2 5BE
        • Suspenderet
        • Royal Sussex County Hospital
      • Bristol, England, Det Forenede Kongerige, BS10 5NB
        • Suspenderet
        • Southmead Hospital
      • Bristol, England, Det Forenede Kongerige, BS2 8EX
        • Aktiv, ikke rekrutterende
        • Bristol Royal Infirmary
      • Burton-on-Trent, England, Det Forenede Kongerige, DE13 0RB
        • Aktiv, ikke rekrutterende
        • Queen's Hospital, Burton
      • Cambridge, England, Det Forenede Kongerige, CB2 0AY
        • Aktiv, ikke rekrutterende
        • Royal Papworth Hospital
      • Cambridge, England, Det Forenede Kongerige, CB2 0QQ
        • Aktiv, ikke rekrutterende
        • Addenbrookes Hospital
      • Carlisle, England, Det Forenede Kongerige, CA2 7HY
        • Suspenderet
        • North Cumberland Infirmary
      • Chertsey, England, Det Forenede Kongerige, KT16 0P
        • Aktiv, ikke rekrutterende
        • St Peter's Hospital
      • Chester, England, Det Forenede Kongerige, CH2 1UL
        • Aktiv, ikke rekrutterende
        • Countess of Chester Hospital
      • Chesterfield, England, Det Forenede Kongerige, S44 5BL
        • Rekruttering
        • Chesterfield Royal Hospital
        • Kontakt:
          • Euan Mackay
      • Colchester, England, Det Forenede Kongerige, CO4 5JL
        • Rekruttering
        • Colchester Hospital
        • Kontakt:
          • Mohamed Ramali
      • Coventry, England, Det Forenede Kongerige, CV2 2DX
        • Aktiv, ikke rekrutterende
        • University Hospital Coventry
      • Darlington, England, Det Forenede Kongerige, DL3 6HX
        • Suspenderet
        • Darlington Memorial Hospital
      • Dartford, England, Det Forenede Kongerige, DA2 8DA
        • Trukket tilbage
        • Darent Valley Hospital
      • Dudley, England, Det Forenede Kongerige, DY1 2HQ
        • Aktiv, ikke rekrutterende
        • Russells Hall Hospital
      • Exeter, England, Det Forenede Kongerige, Ex2 5DW
        • Suspenderet
        • Royal Devon and Exeter Hospital
      • Frimley, England, Det Forenede Kongerige, GU16 7 UJ
        • Suspenderet
        • Frimley Park Hospital
      • Gateshead, England, Det Forenede Kongerige, NE9 6SX
        • Aktiv, ikke rekrutterende
        • Queen Elizabeth Hospital Gateshead
      • Gillingham, England, Det Forenede Kongerige, ME7 5NY
        • Afsluttet
        • Medway Maritime Hospital
      • Great Yarmouth, England, Det Forenede Kongerige, NR31 6LA
        • Afsluttet
        • James Paget University Hospital
      • Guildford, England, Det Forenede Kongerige, GU2 7XX
        • Rekruttering
        • Royal Surrey County Hospital
        • Kontakt:
          • Ben Creagh-Brown
      • Harrow, England, Det Forenede Kongerige, HA1 3UJ
        • Aktiv, ikke rekrutterende
        • Northwick Park Hospital
      • Hereford, England, Det Forenede Kongerige, HR1 2ER
        • Rekruttering
        • Hereford County Hospital
        • Kontakt:
          • Charlotte Small
      • High Barnet, England, Det Forenede Kongerige, EN5 3DJ
        • Aktiv, ikke rekrutterende
        • Barnet Hospital
      • Huddersfield, England, Det Forenede Kongerige, HD3 3EA
        • Aktiv, ikke rekrutterende
        • Huddersfield Royal Infirmary
      • Ilford, England, Det Forenede Kongerige, IG3 8YB
        • Aktiv, ikke rekrutterende
        • King George Hospital
      • Ipswich, England, Det Forenede Kongerige, IP4 5PD
        • Trukket tilbage
        • Ipswich Hospital
      • Kettering, England, Det Forenede Kongerige, NN16 8UZ
        • Rekruttering
        • Kettering Hospital
        • Kontakt:
          • Dhinesh Sundaran
      • Leeds, England, Det Forenede Kongerige, LS9 7TF
        • Aktiv, ikke rekrutterende
        • Leeds General Infirmary
      • Leicester, England, Det Forenede Kongerige, LE1 5WW
        • Suspenderet
        • Leicester Royal Infirmary
      • Leicester, England, Det Forenede Kongerige, LE3 9QP
        • Suspenderet
        • Glenfield Hospital
      • Lincoln, England, Det Forenede Kongerige, LN2 5QY
        • Suspenderet
        • Lincoln County Hospital
      • Liverpool, England, Det Forenede Kongerige, L7 8XP
        • Aktiv, ikke rekrutterende
        • Royal Liverpool University Hospital
      • Liverpool, England, Det Forenede Kongerige, L14 3PE
        • Afsluttet
        • Liverpool Heart and Chest Hospital
      • Liverpool, England, Det Forenede Kongerige, L14 5AB
        • Afsluttet
        • Alder Hey Hospital
      • Liverpool, England, Det Forenede Kongerige, L9 7AL
        • Suspenderet
        • University Hospital Aintree
      • London, England, Det Forenede Kongerige, SE5 9RS
        • Rekruttering
        • King's College Hospital
        • Kontakt:
          • Phillip Hopkins
      • London, England, Det Forenede Kongerige, W12 0HS
        • Rekruttering
        • Hammersmith Hospital
        • Kontakt:
          • Stephen Brett
      • London, England, Det Forenede Kongerige, W2 1NY
        • Rekruttering
        • St Mary's Hospital
        • Kontakt:
          • Anthony Gordon
      • London, England, Det Forenede Kongerige, W6 8RF
        • Rekruttering
        • Charing Cross Hospital
        • Kontakt:
          • David Antcliffe
      • London, England, Det Forenede Kongerige, CR7 7YE
        • Aktiv, ikke rekrutterende
        • Croydon University Hospital
      • London, England, Det Forenede Kongerige, E1 1FR
        • Aktiv, ikke rekrutterende
        • Royal London Hospital
      • London, England, Det Forenede Kongerige, E11 1NR
        • Aktiv, ikke rekrutterende
        • Whipps Cross Hospital
      • London, England, Det Forenede Kongerige, E13 8SL
        • Aktiv, ikke rekrutterende
        • Newham University Hospital
      • London, England, Det Forenede Kongerige, EC1A 7BE
        • Aktiv, ikke rekrutterende
        • St Bartholomew's Hospital
      • London, England, Det Forenede Kongerige, N18 1QX
        • Aktiv, ikke rekrutterende
        • North Middlesex University Hospital
      • London, England, Det Forenede Kongerige, NW3 2QG
        • Aktiv, ikke rekrutterende
        • Royal Free Hospital
      • London, England, Det Forenede Kongerige, SE1 7EH
        • Rekruttering
        • St Thomas Hospital
        • Kontakt:
          • Marlies Ostermann
      • London, England, Det Forenede Kongerige, SE1 9RT
        • Aktiv, ikke rekrutterende
        • Guy's Hospital
      • London, England, Det Forenede Kongerige, SE18 4QH
        • Aktiv, ikke rekrutterende
        • Queen Elizabeth Hospital, Woolwich
      • London, England, Det Forenede Kongerige, SW3 6JJ
        • Aktiv, ikke rekrutterende
        • Royal Marsden Hospital
      • London, England, Det Forenede Kongerige, SW3 6NP
        • Aktiv, ikke rekrutterende
        • Royal Brompton Hospital
      • London, England, Det Forenede Kongerige, SW17 0QT
        • Rekruttering
        • St George's University Hospital
        • Kontakt:
          • Susannah Leaver
      • Luton, England, Det Forenede Kongerige, LU4 0DZ
        • Suspenderet
        • Luton and Dunstable University Hospital
      • Maidstone, England, Det Forenede Kongerige, ME16 9QQ
        • Rekruttering
        • Maidstone Hospital
        • Kontakt:
          • David Golden, MD
      • Manchester, England, Det Forenede Kongerige, M13 9WL
        • Suspenderet
        • Manchester Royal Infirmary
      • Manchester, England, Det Forenede Kongerige, M20 4BX
        • Afsluttet
        • The Christie Hospital
      • Manchester, England, Det Forenede Kongerige, M23 9LT
        • Suspenderet
        • Wythenshawe Hospital
      • Manchester, England, Det Forenede Kongerige, M8 5RB
        • Aktiv, ikke rekrutterende
        • North Manchester General Hospital
      • Metropolitan Borough of Wirral, England, Det Forenede Kongerige, CH49 5PE
        • Rekruttering
        • Arrowe Park Hospital
        • Kontakt:
          • Craig Denmade, MD
      • Middlesbrough, England, Det Forenede Kongerige, TS4 3BW
        • Rekruttering
        • The James Cook University Hospital
        • Kontakt:
          • Jeremy Henning, MD
      • Milton Keynes, England, Det Forenede Kongerige, MK6 5LD
        • Rekruttering
        • Milton Keynes University Hospital
        • Kontakt:
          • Richard Stewart, MD
      • Newcastle, England, Det Forenede Kongerige, NE1 4LP
        • Suspenderet
        • Royal Victoria Infirmary, Newcastle
      • Newcastle, England, Det Forenede Kongerige, NE7 7DN
        • Suspenderet
        • Newcastle Freeman Hospital
      • Northampton, England, Det Forenede Kongerige, NN1 5BD
        • Suspenderet
        • Northampton General Hospital
      • Norwich, England, Det Forenede Kongerige, NR4 7UY
        • Afsluttet
        • Norfolk and Norwich University Hospital
      • Nottingham, England, Det Forenede Kongerige, NG5 1PB
        • Rekruttering
        • City Hospital Nottingham
        • Kontakt:
          • Daniel Harvey, MD
      • Nottingham, England, Det Forenede Kongerige, NG7 2UH
        • Rekruttering
        • Queen's Medical Centre - Nottingham University Hospitals NHS Trust
        • Kontakt:
          • Daniel Harvey, MD
      • Nuneaton, England, Det Forenede Kongerige, CV10 7DJ
        • Aktiv, ikke rekrutterende
        • George Eliot Hospital
      • Oldham, England, Det Forenede Kongerige, Ol1 2JH
        • Rekruttering
        • Royal Oldham Hospital
        • Kontakt:
          • Redmond Tully, MD
      • Orpington, England, Det Forenede Kongerige, BR6 8ND
        • Suspenderet
        • Princess Royal University Hospital
      • Oxford, England, Det Forenede Kongerige, OX3 9DU
        • Aktiv, ikke rekrutterende
        • John Radcliffe Hospital
      • Plymouth, England, Det Forenede Kongerige, PL6 8DH
        • Rekruttering
        • Derriford Hospital
        • Kontakt:
          • Nikitas Nikitas, MD
      • Poole, England, Det Forenede Kongerige, BH15 2JB
        • Rekruttering
        • Poole Hospital NHS Foundation Trust
        • Kontakt:
          • Henrik Reschreiter, MD
      • Portsmouth, England, Det Forenede Kongerige, PO6 3LY
        • Rekruttering
        • Queen Alexandra Hospital
        • Kontakt:
          • David Pogson, MD
      • Prescot, England, Det Forenede Kongerige, L35 5DR
        • Afsluttet
        • Whiston Hospital
      • Preston, England, Det Forenede Kongerige, PR2 9HT
        • Suspenderet
        • Royal Preston Hospital
      • Reading, England, Det Forenede Kongerige, RG1 5AN
        • Rekruttering
        • Royal Berkshire Hospital
        • Kontakt:
          • Andrew Walden, MD
      • Redditch, England, Det Forenede Kongerige, B98 7UB
        • Aktiv, ikke rekrutterende
        • Alexandra Hospital, Redditch
      • Romford, England, Det Forenede Kongerige, RM7 0AG
        • Aktiv, ikke rekrutterende
        • Queen's Hospital Romford
      • Rotherham, England, Det Forenede Kongerige, S60 2UD
        • Rekruttering
        • Rotherham Hospital
        • Kontakt:
          • Anil Hormis, MD
      • Royal Tunbridge Wells, England, Det Forenede Kongerige, TN2 4QJ
        • Rekruttering
        • Tunbridge Wells Hospital - Maidstone and Tunbridge Wells NHS Trust
        • Kontakt:
          • David Golden, MD
      • Salford, England, Det Forenede Kongerige, M6 8HD
        • Rekruttering
        • Salford Royal Hospital
        • Kontakt:
          • Paul Dark, MD
      • Salisbury, England, Det Forenede Kongerige, SP2 8BJ
        • Rekruttering
        • Salisbury District Hospital
        • Kontakt:
          • Phil Donnison, MD
      • Sheffield, England, Det Forenede Kongerige, S10 2JF
        • Rekruttering
        • Royal Hallamshire Hospital
        • Kontakt:
          • Gary Mills, MD
      • Sheffield, England, Det Forenede Kongerige, S5 7AU
        • Rekruttering
        • Northern General Hospital
        • Kontakt:
          • Gary Mills, MD
      • Slough, England, Det Forenede Kongerige, SL2 4HL
        • Aktiv, ikke rekrutterende
        • Wexham Park Hospital
      • South Shields, England, Det Forenede Kongerige, NE34 0PL
        • Rekruttering
        • South Tyneside District Hospital
        • Kontakt:
          • Alistair Roy, MD
      • Southampton, England, Det Forenede Kongerige, SO16 6YD
        • Rekruttering
        • Southampton General Hospital
        • Kontakt:
          • Ahilanandan Dushianthan, MD
      • Stockport, England, Det Forenede Kongerige, SK2 7JE
        • Rekruttering
        • Stepping Hill Hospital
        • Kontakt:
          • Hywel Garrard, MD
      • Stockton-on-Tees, England, Det Forenede Kongerige, TS19 8PE
        • Rekruttering
        • University Hospital of North Tees
        • Kontakt:
          • Farooq Brohi, MD
      • Stoke-on-Trent, England, Det Forenede Kongerige, ST4 6QG
        • Rekruttering
        • Royal Stoke University Hospital
        • Kontakt:
          • Ramprasad Matsa, MD
      • Sunderland, England, Det Forenede Kongerige, SR4 7TP
        • Rekruttering
        • Sunderland Royal Hospital
        • Kontakt:
          • Alistair Roy, MD
      • Sutton in Ashfield, England, Det Forenede Kongerige, NG17 4JL
        • Rekruttering
        • King's Mill Hospital
        • Kontakt:
          • Sandaruwan Herath, MD
      • Swindon, England, Det Forenede Kongerige, SN3 6BB
        • Rekruttering
        • Western General Hospital
        • Kontakt:
          • Jonathan Rhodes, MD
      • Swindon, England, Det Forenede Kongerige, SN3 6BB
        • Aktiv, ikke rekrutterende
        • Great Western Hospital
      • Taunton, England, Det Forenede Kongerige, TA1 5DA
        • Rekruttering
        • Musgrove Park Hospital
        • Kontakt:
          • Richard Innes, MD
      • Torquay, England, Det Forenede Kongerige, TQ2 7AA
        • Rekruttering
        • Torbay Hospital
        • Kontakt:
          • Adam Revill, MD
      • Truro, England, Det Forenede Kongerige, TR1 3LJ
        • Rekruttering
        • Royal Cornwall Hospital
        • Kontakt:
          • Michael Spivey, MD
      • Uxbridge, England, Det Forenede Kongerige, UB9 6JH
        • Afsluttet
        • Harefield Hospital
      • Watford, England, Det Forenede Kongerige, WD18 0HB
        • Rekruttering
        • Watford General Hospital
        • Kontakt:
          • Valarie Page, MD
      • Westcliff-on-Sea, England, Det Forenede Kongerige, ISS0 0RY
        • Aktiv, ikke rekrutterende
        • Southend Hospital
      • Whitehaven, England, Det Forenede Kongerige, CA28 8JG
        • Trukket tilbage
        • West Cumberland Hospital
      • Wigan, England, Det Forenede Kongerige, WN1 2NN
        • Aktiv, ikke rekrutterende
        • Royal Albert Edward Infirmary
      • Winchester, England, Det Forenede Kongerige, SO22 5DG
        • Rekruttering
        • Royal Hampshire County Hospital
        • Kontakt:
          • Irina Grecu, MD
      • Wolverhampton, England, Det Forenede Kongerige, WV10 0QP
        • Aktiv, ikke rekrutterende
        • New Cross Hospital Wolverhampton
      • Worcester, England, Det Forenede Kongerige, WR5 1DD
        • Aktiv, ikke rekrutterende
        • Worcestershire Royal Hospital
      • York, England, Det Forenede Kongerige, Y031 8HE
        • Rekruttering
        • York Teaching Hospital
        • Kontakt:
          • Joseph Carter, MD
    • Northern Ireland
      • Antrim, Northern Ireland, Det Forenede Kongerige, BT41 2RL
        • Rekruttering
        • Antrim Area Hospital
        • Kontakt:
          • Paul Johnston, MD
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT14 6AB
        • Rekruttering
        • Mater Hospital
        • Kontakt:
          • Michael McGinlay, MD
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT9 7AB
        • Rekruttering
        • Belfast City Hospital
        • Kontakt:
          • Michael McGinlay, MD
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT12 6BA
        • Rekruttering
        • Royal Victoria Hospital Belfast
        • Kontakt:
          • Michael McGinlay, MD
      • Londonderry, Northern Ireland, Det Forenede Kongerige, BT47 6SB
        • Rekruttering
        • Altnagelvin Hospital
        • Kontakt:
          • Adrian Donnelly, MD
    • Scotland
      • Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
        • Afsluttet
        • Aberdeen Royal Infirmary
      • Dundee, Scotland, Det Forenede Kongerige, DD1 9SY
        • Rekruttering
        • Ninewells Hospital
        • Kontakt:
          • James Chambers, MD
      • Edinburgh, Scotland, Det Forenede Kongerige, EH16 4SA
        • Rekruttering
        • Royal Infirmary of Edinburgh
        • Kontakt:
          • Thomas Craven, MD
      • Glasgow, Scotland, Det Forenede Kongerige, G4 0SF
        • Rekruttering
        • Glasgow Royal Infirmary
        • Kontakt:
          • Kathryn Puxty, MD
      • Glasgow, Scotland, Det Forenede Kongerige, G51 4TF
        • Rekruttering
        • Queen Elizabeth University Hospital, Glasgow
        • Kontakt:
          • Malcolm Sim, MD
      • Paisley, Scotland, Det Forenede Kongerige, PA2 9PN
        • Rekruttering
        • Royal Alexandra Hospital
        • Kontakt:
          • Kevin Rooney, MD
    • Wales
      • Abergavenny, Wales, Det Forenede Kongerige, NP7 7EG
        • Aktiv, ikke rekrutterende
        • Neville Hall Hospital
      • Bodelwyddan, Wales, Det Forenede Kongerige, LL18 5UJ
        • Aktiv, ikke rekrutterende
        • Glan Clwyd Hospital
      • Bridgend, Wales, Det Forenede Kongerige, CF31 1RQ
        • Aktiv, ikke rekrutterende
        • Princess of Wales Hospital
      • Cardiff, Wales, Det Forenede Kongerige, CF14 4XW
        • Aktiv, ikke rekrutterende
        • Cardiff and Vale University Hospital Wales
      • Carmarthen, Wales, Det Forenede Kongerige, SA31 2AF
        • Suspenderet
        • Glangwilli Hospital
      • Cwmbran, Wales, Det Forenede Kongerige, NP44 8YN
        • Aktiv, ikke rekrutterende
        • Grange University Hospital
      • Newport, Wales, Det Forenede Kongerige, NP20 2UB
        • Suspenderet
        • Royal Gwent Hospital
      • Pont-y-clun, Wales, Det Forenede Kongerige, CF72 8XR
        • Aktiv, ikke rekrutterende
        • Royal Glamorgan Hospital
      • Swansea, Wales, Det Forenede Kongerige, SA6 6NL
        • Aktiv, ikke rekrutterende
        • Morriston Hospital
      • Wrexham, Wales, Det Forenede Kongerige, LL13 7TD
        • Rekruttering
        • Wrexham Maelor Hospital
        • Kontakt:
          • David Southern, MD
      • Tartu, Estland, 50406
        • Suspenderet
        • Tartu University Hospital
      • Helsinki, Finland, 00290
        • Suspenderet
        • Helsinki University Hospital
      • Tampere, Finland, 33520
        • Suspenderet
        • Tampere University Hospital
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32209
        • Rekruttering
        • University of Florida
        • Kontakt:
          • Hadi Hatoum, MD
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Ikke rekrutterer endnu
        • Augusta University
        • Kontakt:
          • Jose Vazquez, MD
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rekruttering
        • University of Illinois Health
        • Kontakt:
          • Jeffrey Jacobson, MD
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Ikke rekrutterer endnu
        • Tulane Medical Center
        • Kontakt:
          • Joshua Denson, MD
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • University of Michigan
        • Kontakt:
          • Robert Hyzy, MD
    • New York
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Kontakt:
          • Stephen Pastores, MD
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1009
        • Ikke rekrutterer endnu
        • Wake Forest Baptist Health
        • Kontakt:
          • Ashish Khanna, MD
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University Wexner Medical Center
        • Kontakt:
          • Matthew Exline, MD
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239-3098
        • Rekruttering
        • Oregon Health and Science University
        • Kontakt:
          • Akram Khankhana, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Rekruttering
        • University of Pittsburgh Medical Centre
        • Kontakt:
          • Stephanie Mongomery
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Ikke rekrutterer endnu
        • Brown University - Rhode Island Hospital
        • Kontakt:
          • Mitchell Levy, MD
      • Argenteuil, Frankrig, 95107
        • Aktiv, ikke rekrutterende
        • CH Argenteuil
      • Aurillac, Frankrig, 15000
        • Afsluttet
        • Centre Hospitalier Henri Mondor d'Aurillac
      • Beauvais, Frankrig, 60000
        • Aktiv, ikke rekrutterende
        • Beauvais General Hospital
      • Belfort, Frankrig, 90400
        • Suspenderet
        • Hopital Nord Franche-Comte
      • Boulogne-Billancourt, Frankrig, 92100
        • Rekruttering
        • Ambroise Pare Hospital
        • Kontakt:
          • Antoine Vieillard Baron, MD
      • Béthune, Frankrig, 62660
        • Rekruttering
        • Centre hospitalier Bethune Beuvry
        • Kontakt:
          • Christophe Vinsonneau, MD
      • Dax, Frankrig, 40100
        • Rekruttering
        • CH de Dax
        • Kontakt:
          • Adrien Auvet, MD
      • Dieppe, Frankrig, 76202
        • Rekruttering
        • Centre Hospitalier de Dieppe
        • Kontakt:
          • Peierre-Louis Declercq, MD
      • Dijon, Frankrig, 21000
        • Rekruttering
        • CHU Dijon Bourgogne
        • Kontakt:
          • Jean-Pierre Quenot, MD
      • Eaubonne, Frankrig, 95600
        • Aktiv, ikke rekrutterende
        • Hopital Simone Veil Eaubonne
      • Garches, Frankrig, 92380
        • Rekruttering
        • Hospital Raymond Poincare
        • Kontakt:
          • Djillali Annane, MD
      • La Roche-sur-Yon, Frankrig, 85000
        • Rekruttering
        • CHD Vendee
        • Kontakt:
          • Gwenael Colin, MD
      • Le Mans, Frankrig, 72027
        • Rekruttering
        • Centre Hospitalier Le Mans
        • Kontakt:
          • Christophe Guitton, MD
      • Limoges, Frankrig, 87000
        • Rekruttering
        • CHU Dupuytren
        • Kontakt:
          • Francois Bruno, MD
      • Melun, Frankrig, 77000
        • Aktiv, ikke rekrutterende
        • Centre Hospitalier de Melun
      • Mont-de-Marsan, Frankrig, 40024
        • Rekruttering
        • Centre Hospitalier Layne - Mont-de-Marsan
        • Kontakt:
          • Arnaud Sement, MD
      • Morlaix, Frankrig, 29600
        • Rekruttering
        • Centre Hospitalier des Pays de Morlaix
        • Kontakt:
          • Pierre Yves Egreteau, MD
      • Orléans, Frankrig, 45100
        • Aktiv, ikke rekrutterende
        • CHR d'Orleans
      • Paris, Frankrig, 75010
        • Aktiv, ikke rekrutterende
        • Lariboisiere Hospital
      • Paris, Frankrig, 75020
        • Aktiv, ikke rekrutterende
        • Hopital Tenon
      • Strasbourg, Frankrig, 67200
        • Aktiv, ikke rekrutterende
        • Hopital de Hautepierre Strasbourg
      • Strasbourg, Frankrig, 67000
        • Rekruttering
        • Nouvel Hopital Civil Strasbourg
        • Kontakt:
          • Ferhat Meziani, MD
      • Tours, Frankrig, 37000
        • Rekruttering
        • CHRU Tours Hopital Bretonneau
        • Kontakt:
          • Emmanuelle Mercier, MD
      • Étampes, Frankrig, 91150
        • Aktiv, ikke rekrutterende
        • Sud Essonne Hospital Etampes
      • 's-Hertogenbosch, Holland
        • Rekruttering
        • Jeroen Bosch Ziekenhuis
        • Kontakt:
          • Koen Simons, M.D.
      • Almelo, Holland, 7609PP
        • Rekruttering
        • ZGT Almelo
        • Kontakt:
          • Bastiaan Wittekamp, MD
      • Amersfoort, Holland
        • Rekruttering
        • Meander Medisch Centrum
        • Kontakt:
          • Laura van Gulik, M.D.
      • Amsterdam, Holland, 1091AC
        • Aktiv, ikke rekrutterende
        • OLVG
      • Arnhem, Holland, 6815AD
        • Rekruttering
        • Rijnstate Hospital
        • Kontakt:
          • Robert-Jan Hassing, MD
      • Deventer, Holland, 7416SE
        • Aktiv, ikke rekrutterende
        • Deventer Hospital
      • Ede, Holland, 6716RP
        • Aktiv, ikke rekrutterende
        • Ziekenhuis Gelderse Vallei
      • Eindhoven, Holland, 5631BM
        • Aktiv, ikke rekrutterende
        • Maxima Medisch Centrum Eindhoven
      • Groningen, Holland
        • Trukket tilbage
        • Martini Hospital Groningen
      • Groningen, Holland
        • Aktiv, ikke rekrutterende
        • University Medical Center Groningen
      • Leeuwarden, Holland, 8934AD
        • Aktiv, ikke rekrutterende
        • Medisch Centrum Leeuwarden
      • Leiden, Holland
        • Rekruttering
        • Leiden University Medical Center
        • Kontakt:
          • Evert De Jonge, Prof.
      • Nijmegen, Holland
        • Rekruttering
        • Radboud University Medical Center
        • Kontakt:
          • Frank van de Veerdonk, Prof.
      • Nijmegen, Holland
        • Rekruttering
        • Canisius Wilhelmina Ziekenhuis
        • Kontakt:
          • Oscar Hoiting, M.D.
      • Roermond, Holland, 6043CV
        • Aktiv, ikke rekrutterende
        • Laurentius Hospital
      • Rotterdam, Holland, 3079DZ
        • Rekruttering
        • Maasstad Ziekenhuis
        • Kontakt:
          • Corstiaan den Uil, MD
      • The Hague, Holland, 2545AA
        • Rekruttering
        • Hagaziekenhuis
        • Kontakt:
          • Thomas Ottens, MD
      • Uden, Holland, 5406PT
        • Aktiv, ikke rekrutterende
        • Bernhoven Hospital
    • Utrecht
      • Utrecht, Utrecht, Holland, 3584 CX
        • Rekruttering
        • University Medical Center Utrecht
        • Kontakt:
          • Marc Bonten, Prof.
        • Kontakt:
          • Lennie Derde, MD
    • Tamil Nadu
      • Chennai, Tamil Nadu, Indien, 600006
        • Aktiv, ikke rekrutterende
        • Apollo Main Hospital
      • Chennai, Tamil Nadu, Indien, 600010
        • Rekruttering
        • Apollo First Med Hospital
        • Kontakt:
          • Meghena Mathew, MD
      • Chennai, Tamil Nadu, Indien, 600095
        • Aktiv, ikke rekrutterende
        • Apollo Vanagaram Hospital
      • Chennai, Tamil Nadu, Indien, 600096
        • Rekruttering
        • Apollo Speciality Hospital - OMR
        • Kontakt:
          • Deva Jayakumar, MD
      • Cork, Irland, T12 DC4A
        • Aktiv, ikke rekrutterende
        • Cork University Hospital
      • Dublin, Irland
        • Rekruttering
        • Beaumont Hospital
        • Kontakt:
          • Ger Curley, Prof.
      • Dublin, Irland
        • Rekruttering
        • St. Vincent's University Hospital
        • Kontakt:
          • Alistair Nichol, Prof.
      • Galway, Irland
        • Rekruttering
        • University Hospital Galway
        • Kontakt:
          • John Laffey, M.D.
      • Waterford, Irland, X91 ER8E
        • Aktiv, ikke rekrutterende
        • University Hospital Waterford
      • Haifa, Israel, 3109601
        • Trukket tilbage
        • Rambam Medical Center
      • Petah Tikva, Israel, 4941492
        • Suspenderet
        • Beilinson Hospital, Rabin Medical Center
      • Poria – Neve Oved, Israel, 1528001
        • Trukket tilbage
        • The Baruch Padeh Medical Center
      • Brescia, Italien, 25123
        • Rekruttering
        • AO Spedali Civili di Brescia
        • Kontakt:
          • Simone Piva, MD
      • Milan, Italien, 20132
        • Rekruttering
        • IRCCS Ospedale San Raffaele
        • Kontakt:
          • Giovanni Landoni, MD
      • Milan, Italien, 20089
        • Rekruttering
        • Humanitas Research Hospital
        • Kontakt:
          • Maurizio Cecconi, MD
      • Milan, Italien, 20122
        • Rekruttering
        • Ca' Granda Ospedale Maggiore Policlinico
        • Kontakt:
          • Francesco Blasi, MD
      • Palermo, Italien, 90127
        • Rekruttering
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
        • Kontakt:
          • Andrea Cortegiani, MD
      • Palermo, Italien, 90127
        • Rekruttering
        • Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
        • Kontakt:
          • Gennaro Martucci, MD
      • Reggio Emilia, Italien, 42123
        • Rekruttering
        • Arcispedale S. Maria Nuova
        • Kontakt:
          • Elena Mantovani, MD
      • Rimini, Italien, 47923
        • Ikke rekrutterer endnu
        • Ospedale Infermi di Rimini
        • Kontakt:
          • Jonathan Montomoli, MD
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Rekruttering
        • St Marianna University School of Medicine
      • Yokohama, Kanagawa, Japan, 236-0004
        • Rekruttering
        • Yokohama City University Hospital
      • Yokohama, Kanagawa, Japan, 241-0811
        • Rekruttering
        • St. Marianna University Yokohama City Seibu Hospital
    • Kumamoto
      • Minami, Kumamoto, Japan, 861-4193
        • Rekruttering
        • Saiseikai Kumamoto Hospital
    • Osaka
      • Osaka, Osaka, Japan, 534-0021
        • Rekruttering
        • Osaka City General Hospital
    • Tokyo
      • Tokyo, Tokyo, Japan, 130-8575
        • Rekruttering
        • Nerima Hikarigaoka Hospital
      • Tokyo, Tokyo, Japan, 130-8575
        • Rekruttering
        • Tokyo Metropolitan Bokutoh Hospital
      • Tokyo, Tokyo, Japan, 174-0051
        • Rekruttering
        • Itabashi Chuo Medical Center
      • Tokyo, Tokyo, Japan, 279-0001
        • Rekruttering
        • Tokyo bay Urayasu-Ichikawa Medical Center
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8509
        • Rekruttering
        • Wakayama Medical University
      • Požega, Kroatien, 34000
        • Rekruttering
        • General County Hospital Požega
        • Kontakt:
          • Zdravko Andrić, MD
      • Zagreb, Kroatien, 10000
        • Rekruttering
        • University Hospital Centre Zagreb
        • Kontakt:
          • Ana Vujaklija Brajković, MD
      • Zagreb, Kroatien, 10000
        • Trukket tilbage
        • University Hospital for Infectious Diseases
      • Bharatpur, Nepal, 44200
        • Rekruttering
        • Chitwan Medical College
        • Kontakt:
          • Basanta Gauli, MD
      • Kathmandu, Nepal, 44600
        • Rekruttering
        • Grande International Hospital
        • Kontakt:
          • Sushil Khanal, MD
      • Kathmandu, Nepal, 44600
        • Rekruttering
        • Hospital for Advanced Medicine and Surgery (HAMS)
        • Kontakt:
          • Hem Paneru, MD
      • Kathmandu, Nepal, 44600
        • Rekruttering
        • Nepal Mediciti
        • Kontakt:
          • Diptesh Aryal, MD
      • Auckland, New Zealand, 0620
        • Rekruttering
        • North Shore Hospital
        • Kontakt:
          • Robert Everitt, MD
      • Auckland, New Zealand, 1023
        • Rekruttering
        • CVICU, Auckland City Hospital
        • Kontakt:
          • Shay McGuinness, MD
      • Auckland, New Zealand, 1023
        • Rekruttering
        • DCCM, Auckland City Hospital
        • Kontakt:
          • Colin McArthur, MD
      • Auckland, New Zealand, 2104
        • Rekruttering
        • Middlemore Hospital
        • Kontakt:
          • Tony Williams, MD
      • Christchurch, New Zealand, 8011
        • Rekruttering
        • Christchurch Hospital
        • Kontakt:
          • Jay Ritzema-Carter, MD
      • Hamilton, New Zealand, 3204
        • Rekruttering
        • Waikato Hospital
        • Kontakt:
          • Robert Martynoga, MD
      • New Plymouth, New Zealand, 4310
        • Rekruttering
        • Taranaki Base Hospital
        • Kontakt:
          • Jonathan Albrett, MD
      • Rotorua, New Zealand, 3010
        • Rekruttering
        • Rotorua Hospital
        • Kontakt:
          • Ulrike Buehner, MD
      • Tauranga, New Zealand, 3112
        • Rekruttering
        • Tauranga Hospital
        • Kontakt:
          • Troy Browne, MD
      • Wellington, New Zealand, 6021
        • Rekruttering
        • Wellington Regional Hospital
        • Kontakt:
          • Paul Young, MD
      • Whangarei, New Zealand, 0148
        • Rekruttering
        • Whangarei Hospital
        • Kontakt:
          • Ralph Fuchs, MD
    • Sindh
      • Karachi, Sindh, Pakistan, 75000
        • Rekruttering
        • Ziauddin University Hospital Clifton Campus
        • Kontakt:
          • Madiha Hashmi, MD
      • Karachi, Sindh, Pakistan, 75300
        • Rekruttering
        • Abbasi Shaheed Hospital
        • Kontakt:
          • Aneela Kidwai, MD
      • Karachi, Sindh, Pakistan, 75510
        • Rekruttering
        • National Institute of Cardiovascular Diseases, Karachi
        • Kontakt:
          • Nawal Salahuddin, MD
      • Karachi, Sindh, Pakistan, 75600
        • Rekruttering
        • South City Hospital, Karachi
        • Kontakt:
          • Nasir Khoso, MD
      • Karachi, Sindh, Pakistan
        • Rekruttering
        • Ziauddin University North Nazimabad Campus
        • Kontakt:
          • Quratul Ain, MD
      • Abrantes, Portugal
        • Rekruttering
        • Centro Hospitalar do Medio Tejo
        • Kontakt:
          • Nuno Catorze, M.D.
      • Lisbon, Portugal, 1169-050
        • Suspenderet
        • Hospital Ocidental
      • Lisbon, Portugal
        • Suspenderet
        • Hospital Lusíadas Lisbon
      • Bucharest, Rumænien, 030303
        • Suspenderet
        • Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
      • Riyadh, Saudi Arabien, 14611
        • Rekruttering
        • King Abdulaziz Medical City
        • Kontakt:
          • Yaseen Arabi, MD
      • Zurich, Schweiz, 8091
        • Suspenderet
        • University Hospital Zürich
      • Belgrade, Serbien, 11000
        • Suspenderet
        • University Hospital Center Dr Dragiša Mišović
      • Belgrade, Serbien, 11000
        • Suspenderet
        • University Clinical Centre of Serbia
      • Niš, Serbien, 18000
        • Rekruttering
        • Clinical Centre of Niš
        • Kontakt:
          • Tanja Pejčić, MD
      • Golnik, Slovenien, 4204
        • Suspenderet
        • University Clinic of Respiratory and Allergic Diseases Golnik
      • Maribor, Slovenien, 2000
        • Rekruttering
        • University Medical Centre Maribor
        • Kontakt:
          • Andre Markota, MD
      • Barcelona, Spanien
        • Rekruttering
        • Hospital del Mar
        • Kontakt:
          • Rosana Munoz-Bermúdez, M.D.
      • Cadiz, Spanien, 11407
        • Rekruttering
        • Hospital Universitario de Jerez
        • Kontakt:
          • Ángel Estella, MD
      • Córdoba, Spanien, 14004
        • Rekruttering
        • Reina Sofia University Hospital
        • Kontakt:
          • Eduardo Aguilar Alonso, M.D.
      • Madrid, Spanien, 28034
        • Rekruttering
        • Ramon y Cajal University Hospital
        • Kontakt:
          • Cruz Soriano, MD
      • Málaga, Spanien, 29010
        • Rekruttering
        • Hospital Regional de Málaga
        • Kontakt:
          • Manuel Herrera Gutiérrez, MD
      • Ourense, Spanien, 32005
        • Rekruttering
        • Hospital Universitario de Ourense
        • Kontakt:
          • Pablo Vidal, MD
      • Santander, Spanien, 39008
        • Rekruttering
        • Hospital Marqués de Valdecilla
        • Kontakt:
          • Borja Suberviola, MD
      • Tortosa, Spanien, 43500
        • Rekruttering
        • Hospital Verge de la Cinta
        • Kontakt:
          • Ferran Roche Campo, MD
      • Valencia, Spanien, 46026
        • Rekruttering
        • Hospital La Fe
        • Kontakt:
          • Paula Ramírez, MD
      • Valencia, Spanien, 46017
        • Rekruttering
        • Doctor Peset University Hospital
        • Kontakt:
          • Rafael Zaragoza, MD
      • Prague, Tjekkiet, 10000
        • Rekruttering
        • Fakultní nemocnice Královské Vinohrady
        • Kontakt:
          • František Duška, MD
      • Teplice, Tjekkiet, 41501
        • Suspenderet
        • Teplice Hospital
      • Berlin, Tyskland, 10117
        • Trukket tilbage
        • Charité - Universitätsmedizin Berlin - Infektiologie und Pneumologie
      • Berlin, Tyskland, 12351
        • Afsluttet
        • Vivantes Klinikum Neukölln
      • Berlin, Tyskland, 13509
        • Trukket tilbage
        • Vivantes Humboldt-Klinikum
      • Berlin, Tyskland, 13353
        • Suspenderet
        • Charite Universitätsmedizin Berlin
      • Cologne, Tyskland, 50937
        • Trukket tilbage
        • University Hospital of Cologne
      • Cottbus, Tyskland, 03058
        • Afsluttet
        • Carl-Thiem-Klinikum Cottbus
      • Dortmund, Tyskland, 44137
        • Afsluttet
        • Klinikum Dortmund
      • Essen, Tyskland, 45138
        • Afsluttet
        • Elisabeth Hospital Essen
      • Frankfurt, Tyskland, 60590
        • Trukket tilbage
        • Universitätsklinikum Frankfurt
      • Hamburg, Tyskland, 20251
        • Suspenderet
        • University Medical Center Hamburg-Eppendorf (UKE)
      • Jena, Tyskland, 07747
        • Suspenderet
        • Universitätsklinikum Jena
      • Leipzig, Tyskland, 04103
        • Suspenderet
        • University Hospital Leipzig
      • Leipzig, Tyskland, 04103
        • Suspenderet
        • Universitätsklinikum Leipzig
      • München, Tyskland, 81675
        • Suspenderet
        • Klinikum rechts der Isar der TU München
      • Münster, Tyskland, 48149
        • Suspenderet
        • Universitätsklinikum Münster
      • Tübingen, Tyskland, 72076
        • Afsluttet
        • Universitäts Klinikum Tübingen
      • Würzburg, Tyskland, 97080
        • Suspenderet
        • Universitätsklinikum Würzburg
      • Nyíregyháza, Ungarn, 4400
        • Afsluttet
        • Jósa András County Hospital
      • Ózd, Ungarn, 3600
        • Afsluttet
        • Almási Balogh Pál Kórház

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 uger og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

The eligibility criteria for the Platform are applied at multiple levels. One level is that there are inclusion and exclusion criteria that determine eligibility for randomization within the Platform. Another level is that, once eligible for inclusion within the Platform, additional criteria (typically exclusion criteria) are applied that are specific to each domain. Finally, intervention-level eligibility criteria may be applied for interventions within a domain. A patient is eligible for inclusion within a domain when:

  • All Platform inclusion criteria are met
  • None of the Platform exclusion criteria are met
  • Domain-specific eligibility criteria are met
  • The patient is eligible for at least two interventions within a domain

As such, the key "inclusion criteria" for being eligible for a domain are that the patient is eligible for the Platform.

--

PLATFORM INCLUSION CRITERIA:

  1. Hospitalised patient
  2. Acute respiratory tract infection
  3. Aged 28 days or older

PLATFORM EXCLUSION CRITERIA:

  1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
  2. Patient is expected to be discharged from hospital within the next 24 hours
  3. Previous participation in this REMAP within the last 90 days

DOMAIN-SPECIFIC ELIGIBILITY CRITERIA:

Each domain may have additional eligibility criteria. Refer to the study website for more information (www.remapcap.org).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Antibiotic Domain

Patients with community-acquired pneumonia and requiring empiric antibiotic therapy will be randomised one of five antibiotic interventions.

Note: the ceftaroline + macrolide intervention has been closed to recruitment.

The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Note: this intervention is now closed.

The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Andet: Macrolide Duration Domain

Patients with community-acquired pneumonia who have been allocated to receive a beta-lactam + macrolide intervention in the Antibiotic Domain will be randomised to either a standard course or extended course of macrolide therapy

Standard course of macrolide therapy, discontinued between study day 3 and the end of study day 5.

The dosing of and route of administration is not protocolised, the following guidance is provided:

  • Initial IV administration of a macrolide is strongly preferred
  • The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
  • The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted.

Extended course of macrolide therapy discontinued at the end of study day 14 or hospital discharge (whichever occurs first).

The dosing of and route of administration is not protocolised, the following guidance is provided:

  • Initial IV administration of a macrolide is strongly preferred
  • The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
  • The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted.
Andet: Corticosteroid Domain

Patients with severe lower-respiratory tract infection will be randomised to a steroid use strategy.

Note: this domain is now closed to patients with suspected or proven COVID-19. It remains open to patients with CAP without COVID-19.

Note: the fixed-course hydrocortisone has been closed to recruitment

Patients are not to receive any systemic corticosteroids, including hydrocortisone, to study day 28 or hospital discharge (whichever occurs first).

50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.

Note: this intervention is now closed.

50mg IV hydrocortisone every 6 hours while the patient is in septic shock

100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.

Note: this intervention was only available to patients with suspected or proven COVID-19 and is now closed.

6 mg of IV or enteral dexamethasone will be administered daily for up to 10 days while in hospital.

Andet: Influenza Antiviral Domain

Patients with microbiological testing confirmed influenza infection will be randomised to one of six interventions.

No antiviral agent intended to be active against influenza infection is to be administered

Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first)

Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first)

Baloxavir marboxil administered on days 1 and 4 post-randomisation.

Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation.

Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation.

Andet: COVID-19 Antiviral Domain

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to no ivermectin or ivermectin.

Note: an earlier version of this domain evaluated lopinavir-ritonavir, hydroxychloroquine, and combination lopinavir-ritonavir and hydroxychloroquine against a 'no antiviral' control.

This domain is now closed.

No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered

Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.

Note: this intervention is now closed.

Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).

Note: this intervention is now closed.

Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.

Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).

Note: this intervention is now closed.

Ivermectin administered enterally at a dose of 0.2 mg/kg once daily with a maximum daily dose of 24mg/day.

Note: this intervention is now closed.

Andet: COVID-19 Immune Modulation Domain

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five interventions.

Note: this domain is now closed.

No immune modulating agent intended to be active against COVID-19 is to be administered.

Note: this intervention is now closed.

IFN-β1a 10 μg will be administered as an intravenous bolus injection via a central or peripheral line. IFN-β1a will be administered once daily for 6 days or until ICU discharge, whichever occurs first.

Note: this intervention is now closed.

Andre navne:
  • IFN-β1a

A loading dose of 300mg anakinra will be administered as a bolus via central or peripheral line. This is followed by maintenance doses of 100mg of anakinra administered every 6 hours.

In patients with renal impairment, anakinra will be administered on alternate days.

Note: this intervention is now closed.

Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg.

Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.

Note: this intervention is now closed.

Sarilumab will be administered as a single dose of 400mg, via IV infusion through peripheral or central line over a one-hour period.

Note: this intervention is now closed.

Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg. In children weighing less than 30kg, tocilizumab dose will be 12mg/kg.

Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.

Andet: Anticoagulation Domain

Patients admitted to participating intensive care units with suspected or microbiological testing confirmed COVID-19 will be randomised to an anticoagulation strategy.

Note: A previous version of this domain evaluated local standard venous thromboprophylaxis against therapeutic dose anticoagulation. This domain is now closed.

Standard venous thromboprophylaxis that complies with local guidelines or usual practice will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Patients will be administered either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) to achieve systemic anticoagulation. Either agent may be used and the same patient may be switched between UFH and LMWH at the discretion of the treating clinician.

Note: this intervention is now closed.

Low dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.

Intermediate dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.

Patients already receiving therapeutic dose anticoagulation at the time of randomisation to this intervention will be administered either unfractionated heparin by IV infusion or low-molecular weight heparin to achieve systemic anticoagulation according to local practice for acute VTE treatment for 14 days following randomisation or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Andet: Immunoglobulin Domain

Immunosuppressed patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive no immunoglobulin for COVID-19, or to receive high-titre convalescent plasma.

Note: an earlier version of this domain was not restricted to immunosuppressed patients.

No immunoglobulin intended to be active against SARS-CoV-2 infection is to be administered.

Patients will receive at least one and no more than two units of ABO compatible convalescent plasma within 48 hours of randomisation.

Note: this intervention is now closed.

Andet: Vitamin C Domain

Patients admitted to participating hospitals with community-acquired pneumonia will be randomised to receive no vitamin C, or vitamin C.

Note: this domain is now closed.

No high dose intravenous vitamin C is to be administered

Note: this intervention is now closed.

Intravenous Vitamin C 50mg/kg administered every 6 hours for 16 doses

Note: this intervention is now closed.

Andet: Simvastatin Domain

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no simvastatin, or simvastatin.

Note: this domain is now closed.

No simvastatin intended to be active against COVID-19 is to be administered

Note: this intervention is now closed.

Simvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation

Note: this intervention is now closed.

Andet: Antiplatelet Domain

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no antiplatelet, aspirin, or site-preferred P2Y12 inhibitor.

Note: this domain is now closed.

No antiplatelet agent or NSAID to be administered.

Note: this intervention is now closed.

Aspirin administered at either 75mg or 100mg once per day for 14 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Andre navne:
  • acetylsalicylsyre

Site-selected P2Y12 inhibitor:

  • Clopidogrel: administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first.
  • Prasugrel: If patient is aged less than 75 years and measured or estimated weight if 60kg or more, and initial loading dose of prasugrel 60 mg will be administered, followed by maintenance dose of 10 mg per day.
  • Ticagrelor: administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Andre navne:
  • Prasugrel
  • Clopidogrel
  • Ticagrelor
Andet: Mechanical Ventilation Domain

Patients with community-acquired pneumonia admitted to participating intensive care units who are intubated and receiving invasive mechanical ventilation will be randomised to protocolised mechanical ventilation strategy, or clinician-preferred mechanical ventilation strategy

Clinician-preferred ventilation strategy, including mode of ventilation and all ventilatory parameters

Invasive mechanical ventilation strategy delivered as outlined in relevant protocol documents for this domain.

Andet: COVID-19 Immune Modulation (2) Domain

Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive one of three interventions.

Note: this domain is now closed.

No immune modulating agent intended to be active against COVID-19 is to be administered.

Note: this intervention is now closed.

Eritoran initiated with a 26.24 mg loading dose (6.56 mg/h IV for 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h IV for 2 hours) at 12 hours after initiation. Patients will then receive twenty-six 6.56 mg maintenance doses (3.28 mg/h IV for 2 hours) every 12 hours thereafter (total of 14 days). Dosing will be stopped if the patient is discharged from hospital

Note: this intervention is now closed.

Apremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Andet: ACE2 RAS Domain

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five renin-angiotensin system blockade strategies.

Note: this domain is now closed.

No RAS inhibitor (i.e. no ACEi or ARB) is to be administered up to the end of study day 10.

Note: this intervention is now closed.

Site-preferred ACEi agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Andre navne:
  • Lisinopril
  • Perindopril
  • Ramipril
  • Captopril
  • Enalapril
  • Trandolapril

Site-preferred ARB agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Andre navne:
  • Valsartan
  • Losartan
  • Candesartan
  • Irbesartan
  • Olmesartan
  • Telmisartan

Site-preferred ARB agent administered in combination with DMX-200 for 10 days or until hospital discharge, whichever occurs first.

ARB administered as directed by the treating clinician. DMX-200 administered enterally at a dose of 120mg twice daily.

Note: this intervention is now closed.

Andet: Cysteamine Domain

Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no cysteamine, or cysteamine.

Note: this domain is now closed.

No cysteamine to be administered until the end of study day 10 or hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Cysteamine administered every 8 hours at a dose of 5 mg/kg estimated or measured body weight (maximum dose of 500mg), for ten days or until ICU discharge, whichever occurs first.

Note: this intervention is now closed.

Andet: Endothelial Domain

Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no endothelial modulator or enteral imatinib.

No endothelial modulator (imatinib or another tyrosine kinase inhibitor targeting the same pathway as imatinib) is to be administered.

Enteral imatinib will be administered as a single 800mg loading dose (study day 1) followed by 400mg daily until study day 14 or discharge.

Andet: Influenza Immune Modulation

Patients with community-acquired pneumonia admitted to participating intensive care units with microbiological testing confirmed influenza infection will be randomised to one of three interventions.

Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg.

Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.

Note: this intervention is now closed.

Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg. In children weighing less than 30kg, tocilizumab dose will be 12mg/kg.

Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.

No immune modulating agent intended to be active against influenza is to be administered.

Baricitinib will be administered at a dose that is determined by age and renal function, for up to 10 days or hospital discharge (whichever occurs first).

Andet: COVID-19 Antiviral (II) Domain

Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to one of up to four interventions.

No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered

Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days.

Andre navne:
  • Paxlovid

Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.

Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days. Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.

Andet: Tropical Antibiotic Domain

Patients with community-acquired pneumonia in regions at locations where or when empiric cover for melioidosis is appropriate, and requiring empiric antibiotic therapy including cover for melioidosis, will be randomised one of two antibiotic interventions

The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survival and Recovery Trajectory up to day 90
Tidsramme: Day 90

The primary endpoint, named Survival and Recovery Trajectory, is a composite of: 90-day all-cause mortality and, among survivors, the number of days on which the patient was not receiving organ failure support during the index hospitalisation, up to the end of study day 28; and, among survivors who never receive organ failure support, hospital free days for the index hospitalisation up to the end of study day 28.

For the purposes of this endpoint, organ failure support is defined as:

  • Extracorporeal life support
  • Invasive mechanical ventilation
  • Non-invasive ventilation
  • High-flow nasal oxygen
  • Continuous infusion of vasopressors, inotropes or both
Day 90

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: Day 90

All-cause mortality to day 90 post-randomisation

Day 90
Days alive and free from organ-failure support
Tidsramme: Day 28

Days alive and free from organ failure support during the index hospitalisation to day 28

Day 28
Days alive and out of hospital
Tidsramme: Day 28

Days alive and out of hospital for the index hospitalisation, to day 28

Day 28
Health-related Quality of life assessment
Tidsramme: 6 months

EQ5D-5L and WHODAS 2.0 (not completed in all regions)

6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Domain-Specific Secondary Outcome
Tidsramme: During the index hospitalisation to Day 90 post-randomisation, unless otherwise specified

Each domain may specify domain-specific secondary outcomes. Please see relevant Domain-Specific Protocol Documents for details.

During the index hospitalisation to Day 90 post-randomisation, unless otherwise specified

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studiestol: Steve Webb, Prof, Monash University, Study Chair REMAP-CAP Australia
  • Studiestol: Colin McArthur, Dr, Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
  • Studiestol: Marc Bonten, Prof, UMC Utrecht, Study Chair REMAP-CAP Europe
  • Studiestol: Lennie Derde, MD, UMC Utrecht, Coordinating Investigator REMAP-CAP Europe
  • Studiestol: John Marshall, Prof, Unity Health Toronto, Study Chair REMAP-CAP Canada
  • Studiestol: Derek Angus, Prof, University of Pittsburgh Medical Center, Study Chair REMAP-CAP USA
  • Studiestol: Luis Felipe Reyes, MD, MSc, PhD, Clínica Universidad de la Sabana, Study Chair REMAP-CAP Colombia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. april 2016

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

11. december 2015

Først indsendt, der opfyldte QC-kriterier

6. april 2016

Først opslået (Anslået)

13. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • U1111-1189-1653
  • 2015-002340-14 (EudraCT nummer)
  • 602525 (Andet bevillings-/finansieringsnummer: European Union, FP7-HEALTH-2013-INNOVATION-1, PREPARE)
  • 16/631 (Andet bevillings-/finansieringsnummer: Health Research Council of New Zealand)
  • APP1101719 (Andet bevillings-/finansieringsnummer: National Health and Medical Research Council, Australia)
  • 158584 (Andet bevillings-/finansieringsnummer: Canadian Institute of Health Research)
  • 2023-507889-89-00 (Ctis)
  • 2023 (U.S. NIH-bevilling/kontrakt)
  • 2015 (U.S. NIH-bevilling/kontrakt)
  • 965313 (Andet bevillings-/finansieringsnummer: European Union, Horizon 2020 research and innovation programme, ECRAID-Base)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .