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Ensayo de plataforma adaptativa multifactorial, integrado y aleatorizado para la neumonía adquirida en la comunidad (REMAP-CAP)

30 de octubre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

20000

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

4 semanas y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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.

Otro: 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.
Otro: 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.

Otro: 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.

Otro: 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.

Otro: 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.

Otros nombres:
  • 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.

Otro: 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.

Otro: 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.

Otro: 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.

Otro: 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.

Otro: 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.

Otros nombres:
  • ácido acetilsalicílico

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.

Otros nombres:
  • Prasugrel
  • Clopidogrel
  • Ticagrelor
Otro: 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.

Otro: 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.

Otro: 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.

Otros nombres:
  • 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.

Otros nombres:
  • Valsartán
  • Losartán
  • Candesartán
  • Irbesartán
  • Olmesartán
  • Telmisartán

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.

Otro: 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.

Otro: 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.

Otro: 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).

Otro: 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.

Otros nombres:
  • 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.

Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Survival and Recovery Trajectory up to day 90
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
All-cause mortality
Periodo de tiempo: Day 90

All-cause mortality to day 90 post-randomisation

Day 90
Days alive and free from organ-failure support
Periodo de tiempo: 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
Periodo de tiempo: Day 28

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

Day 28
Health-related Quality of life assessment
Periodo de tiempo: 6 months

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

6 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Domain-Specific Secondary Outcome
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de abril de 2016

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de febrero de 2029

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

6 de abril de 2016

Publicado por primera vez (Estimado)

13 de abril de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • U1111-1189-1653
  • 2015-002340-14 (Número EudraCT)
  • 602525 (Otro número de subvención/financiamiento: European Union, FP7-HEALTH-2013-INNOVATION-1, PREPARE)
  • 16/631 (Otro número de subvención/financiamiento: Health Research Council of New Zealand)
  • APP1101719 (Otro número de subvención/financiamiento: National Health and Medical Research Council, Australia)
  • 158584 (Otro número de subvención/financiamiento: Canadian Institute of Health Research)
  • 2023-507889-89-00 (Ctis)
  • 2023 (Subvención/contrato del NIH de EE. UU.)
  • 2015 (Subvención/contrato del NIH de EE. UU.)
  • 965313 (Otro número de subvención/financiamiento: European Union, Horizon 2020 research and innovation programme, ECRAID-Base)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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