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Prova della piattaforma adattiva multifattoriale, randomizzata, incorporata per la polmonite acquisita in comunità (REMAP-CAP)

30 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20000

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

4 settimane e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.

Altro: 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.
Altro: 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.

Altro: 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.

Altro: 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.

Altro: 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.

Altri nomi:
  • 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.

Altro: 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.

Altro: 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.

Altro: 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.

Altro: 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.

Altro: 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.

Altri nomi:
  • acido acetilsalicilico

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.

Altri nomi:
  • Prasugrel
  • Clopidogrel
  • Ticagrelor
Altro: 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.

Altro: 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.

Altro: 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.

Altri nomi:
  • 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.

Altri nomi:
  • 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.

Altro: 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.

Altro: 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.

Altro: 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).

Altro: 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.

Altri nomi:
  • 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.

Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Survival and Recovery Trajectory up to day 90
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause mortality
Lasso di tempo: Day 90

All-cause mortality to day 90 post-randomisation

Day 90
Days alive and free from organ-failure support
Lasso di tempo: 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
Lasso di tempo: Day 28

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

Day 28
Health-related Quality of life assessment
Lasso di tempo: 6 months

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

6 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Domain-Specific Secondary Outcome
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 aprile 2016

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 febbraio 2029

Date di iscrizione allo studio

Primo inviato

11 dicembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

6 aprile 2016

Primo Inserito (Stimato)

13 aprile 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • U1111-1189-1653
  • 2015-002340-14 (Numero EudraCT)
  • 602525 (Altro numero di sovvenzione/finanziamento: European Union, FP7-HEALTH-2013-INNOVATION-1, PREPARE)
  • 16/631 (Altro numero di sovvenzione/finanziamento: Health Research Council of New Zealand)
  • APP1101719 (Altro numero di sovvenzione/finanziamento: National Health and Medical Research Council, Australia)
  • 158584 (Altro numero di sovvenzione/finanziamento: Canadian Institute of Health Research)
  • 2023-507889-89-00 (Ctis)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 2015 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 965313 (Altro numero di sovvenzione/finanziamento: European Union, Horizon 2020 research and innovation programme, ECRAID-Base)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .