Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (REMAP-CAP)

July 10, 2024 updated by: 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 patients admitted to intensive care with community-acquired pneumonia.

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.

Study Overview

Status

Recruiting

Conditions

Community-acquired Pneumonia, Influenza, COVID-19

Intervention / Treatment

Detailed Description

Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality.

Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.

This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to:

Evaluate multiple treatment strategies, at the same time, in the same patient.
Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached
Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial
New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended
Interactions between interventions in different domains can be evaluated

It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission.

Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.

Study Type

Interventional

Enrollment (Estimated)

20000

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Cameron Green, MSc
Email: info@remapcap.org

Study Contact Backup

Name: Svenja Peters, MSc
Email: EU.remapcap@umcutrecht.nl

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

REMAP-CAP PLATFORM INCLUSION CRITERIA:

Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:
1. symptoms or signs or both that are consistent with lower respiratory tract infection AND
2. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate)
Up to 48 hours after ICU admission, receiving organ support with one or more of:
1. Non-invasive or Invasive ventilatory support;
2. Receiving infusion of vasopressor or inotropes or both

PLATFORM EXCLUSION CRITERIA:

Healthcare-associated pneumonia:
1. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
2. Resident of a nursing home or long term care facility
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
Previous participation in this REMAP within the last 90 days

REMAP-COVID PLATFORM INCLUSION CRITERIA

1. Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection.

REMAP-COVID PLATFORM EXCLUSION CRITERIA

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
Patient is expected to be discharged from hospital today or tomorrow
More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection.
Previous participation in this REMAP within the last 90 days

DOMAIN-SPECIFIC ELIGIBLE CRITERIA:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Macrolide Duration Domain Patients with community-acquired pneumonia admitted to participating intensive care units who have been allocated to a beta-lactam antibiotic intervention in the Antibiotic Domain will be randomised to either a standard course or extended course of macrolide therapy	Drug: Standard course macrolide 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. Drug: Extended course macrolide 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.
Other: 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	Procedure: Clinician-preferred mechanical ventilation strategy Clinician-preferred ventilation strategy, including mode of ventilation and all ventilatory parameters Procedure: Protocolised mechanical ventilation strategy Invasive mechanical ventilation strategy delivered as outlined in relevant protocol documents for this domain.
Other: Antibiotic Domain Patients with community-acquired pneumonia admitted to participating intensive care units and requiring empiric antibiotic therapy will be randomised one of five antibiotic interventions. Note: the ceftaroline + macrolide intervention has been closed to recruitment.	Drug: Ceftriaxone The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. Drug: Moxifloxacin or Levofloxacin The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. Drug: Piperacillin-tazobactam The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. Drug: Amoxicillin-clavulanate The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. Drug: Ceftaroline 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.
Other: 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.	Other: No antiviral agent for COVID-19 No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered Drug: Lopinavir / Ritonavir 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. Drug: Hydroxychloroquine 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. Drug: Hydroxychloroquine + lopinavir/ritonavir 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. Drug: Ivermectin 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.
Other: 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.	Other: No immune modulation for COVID-19 No immune modulating agent intended to be active against COVID-19 is to be administered. Note: this intervention is now closed. Drug: Interferon beta-1a 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. Other Names: IFN-β1a Drug: Anakinra 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. Drug: Sarilumab 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. Drug: Tocilizumab 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. Drug: Tocilizumab 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.
Other: 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.	Biological: Delayed administration of convalescent plasma Note: this intervention is now closed. Other: No immunoglobulin No immunoglobulin intended to be active against SARS-CoV-2 infection is to be administered. Biological: Convalescent plasma Patients will receive at least one and no more than two units of ABO compatible convalescent plasma within 48 hours of randomisation.
Other: 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.	Other: No vitamin C No high dose intravenous vitamin C is to be administered Note: this intervention is now closed. Drug: Vitamin C Intravenous Vitamin C 50mg/kg administered every 6 hours for 16 doses Note: this intervention is now closed.
Other: 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.	Other: No simvastatin No simvastatin intended to be active against COVID-19 is to be administered Note: this intervention is now closed. Drug: Simvastatin 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.
Other: 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.	Other: No immune modulation for COVID-19 No immune modulating agent intended to be active against COVID-19 is to be administered. Note: this intervention is now closed. Drug: Apremilast Apremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first. Note: this intervention is now closed. Drug: Eritoran 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.
Other: 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.	Other: No renin-angiotensin system inhibitor 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. Drug: Angiotensin converting enzyme inhibitor 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. Other Names: Lisinopril Perindopril Ramipril Captopril Enalapril Trandolapril Drug: Angiotensin Receptor Blockers 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. Other Names: Valsartan Losartan Candesartan Irbesartan Olmesartan Telmisartan Drug: ARB + DMX-200 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.
Other: 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.	Other: No endothelial modulator No endothelial modulator (imatinib or another tyrosine kinase inhibitor targeting the same pathway as imatinib) is to be administered. Drug: Imatinib Enteral imatinib will be administered as a single 800mg loading dose (study day 1) followed by 400mg daily until study day 14 or discharge.
Other: Influenza Antiviral Domain Patients with community-acquired pneumonia admitted to participating hospitals with microbiological testing confirmed influenza infection will be randomised to one of six interventions.	Other: No antiviral agent for influenza No antiviral agent intended to be active against influenza infection is to be administered Drug: Five-days oseltamivir Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first) Drug: Ten-days oseltamivir Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first) Drug: Baloxavir Marboxil Baloxavir marboxil administered on days 1 and 4 post-randomisation. Drug: Five-days oseltamivir + baloxavir marboxil 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. Drug: Ten-days oseltamivir + baloxavir marboxil 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.
Other: 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.	Drug: Local standard venous thromboprophylaxis 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. Drug: Conventional low dose thromboprophylaxis 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. Drug: Intermediate dose thromboprophylaxis 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. Drug: Therapeutic dose anticoagulation 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. Drug: Continuation of therapeutic dose anticoagulation 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.
Other: 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.	Other: No antiplatelet No antiplatelet agent or NSAID to be administered. Note: this intervention is now closed. Drug: Aspirin 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. Other Names: acetylsalicylic acid Drug: P2Y12 inhibitor 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. Other Names: Prasugrel Clopidogrel Ticagrelor
Other: 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.	Other: No cysteamine No cysteamine to be administered until the end of study day 10 or hospital discharge, whichever occurs first. Note: this intervention is now closed. Drug: Cysteamine 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.
Other: 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.	Drug: Tocilizumab 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. Other: No Immune Modulator for Influenza No immune modulating agent intended to be active against influenza is to be administered. Drug: Baricitinib 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). Drug: Tocilizumab 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.
Other: 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.	Other: No antiviral agent for COVID-19 No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered Drug: Nirmatrelvir/ritonavir Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days. Other Names: Paxlovid Drug: Remdesivir 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. Drug: Nirmatrelvir/ritonavir + remdesivir 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.
Other: Corticosteroid Domain Patients with community acquired pneumonia (CAP) admitted to participating hospitals 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	Other: No systemic corticosteroid Patients are not to receive any systemic corticosteroids, including hydrocortisone, to study day 28 or hospital discharge (whichever occurs first). Drug: Shock-dependent hydrocortisone 50mg IV hydrocortisone every 6 hours while the patient is in septic shock Drug: Fixed-duration higher dose Hydrocortisone 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. Drug: Fixed-duration dexamethasone 6 mg of IV or enteral dexamethasone will be administered daily for up to 10 days while in hospital. Drug: Fixed-duration Hydrocortisone 50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days. Note: this intervention is now closed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality Time Frame: Day 90		Day 90
Days alive and not receiving organ support in ICU Time Frame: Day 21	Primary end-point for patients with suspected or proven COVID-19 pandemic infection	Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality Time Frame: 6 months		6 months
Hospital length of stay Time Frame: Day 90		Day 90
ICU Mortality Time Frame: Day 90		Day 90
ICU length of stay Time Frame: Day 90		Day 90
Ventilator free days Time Frame: Day 28		Day 28
Organ failure free days Time Frame: Day 28		Day 28
Health-related Quality of life assessment Time Frame: 6 months	EQ5D-5L and WHODAS 2.0 (not completed in all regions)	6 months
Proportion of intubated patients who receive a tracheostomy Time Frame: Day 28		Day 28
Destination at time of hospital discharge Time Frame: Free text Day 90	Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital	Free text Day 90
Readmission to the index ICU during the index hospitalization Time Frame: Day 90		Day 90
World Health Organisation 8-point ordinal scale outcome Time Frame: Hospital discharge		Hospital discharge

Other Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

National University Hospital, Singapore

Berry Consultants

University of Pittsburgh Medical Center

Global Coalition for Adaptive Research

Australian and New Zealand Intensive Care Research Centre

Intensive Care National Audit & Research Centre

Nat Intensive Care Surveillance - MORU

Medical Research Institute of New Zealand

St. Marianna University School of Medicine

Unity Health

Investigators

Study Chair: Steve Webb, Prof, Monash University, Study Chair REMAP-CAP Australia
Study Chair: Colin McArthur, Dr, Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
Study Chair: Marc Bonten, Prof, UMC Utrecht, Study Chair REMAP-CAP Europe
Study Chair: Lennie Derde, MD, UMC Utrecht, Coordinating Investigator REMAP-CAP Europe
Study Chair: John Marshall, Prof, Unity Health Toronto, Study Chair REMAP-CAP Canada
Study Chair: Derek Angus, Prof, University of Pittsburgh Medical Center, Study Chair REMAP-CAP USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2016

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimated)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

U1111-1189-1653
2015-002340-14 (EudraCT Number)
602525 (Other Grant/Funding Number: European Union, FP7-HEALTH-2013-INNOVATION-1, PREPARE)
16/631 (Other Grant/Funding Number: Health Research Council of New Zealand)
APP1101719 (Other Grant/Funding Number: National Health and Medical Research Council, Australia)
158584 (Other Grant/Funding Number: Canadian Institute of Health Research)
965313 (Other Grant/Funding Number: European Union)
2023-507889-89-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
Occurrence of multi-resistant organism colonisation/infection Time Frame: Day 90, censored at hospital discharge	Antibiotic Domain specific outcome	Day 90, censored at hospital discharge
Occurrence clostridium difficile Time Frame: Day 90, censored at hospital discharge	Antibiotic Domain specific outcome	Day 90, censored at hospital discharge
Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death Time Frame: Day 90, censored at hospital discharge	Macrolide Duration Domain specific outcome.	Day 90, censored at hospital discharge
Change from baseline influenza virus levels in upper and lower respiratory tract specimens Time Frame: Day 3, up to Day 7	Antiviral Domain specific outcome. Only required at selected sites.	Day 3, up to Day 7
Confirmed deep vein thrombosis Time Frame: Between randomisation and hospital discharge	Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.	Between randomisation and hospital discharge
Confirmed pulmonary embolism Time Frame: Between randomisation and hospital discharge	Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.	Between randomisation and hospital discharge
Confirmed ischaemic cerebrovascular event Time Frame: Between randomisation and hospital discharge	Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.	Between randomisation and hospital discharge
Total red blood cell units transfused Time Frame: Between randomisation and end of study day 15	Domain-specific outcome for Anticoagulation and Antiplatelet Domains.	Between randomisation and end of study day 15
Confirmed acute myocardial infarction Time Frame: Between randomisation and hospital discharge	Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.	Between randomisation and hospital discharge
Peak troponin Time Frame: Between randomisation and end of study day 15	Domain-specific outcome for Anticoagulation and Antiplatelet Domains.	Between randomisation and end of study day 15
Major bleeding event Time Frame: Between randomisation and end of study day 15	Domain-specific outcome for Anticoagulation and Antiplatelet Domains.	Between randomisation and end of study day 15
Other confirmed thrombotic event, including mesenteric ischaemia and limb ischaemia Time Frame: Between randomisation and hospital discharge	Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.	Between randomisation and hospital discharge
Acute kidney injury (KDIGO stage >= 2 acute kidney injury) Time Frame: Between randomisation and 7 days	Domain-specific outcome for ACE2 RAS Domain	Between randomisation and 7 days
Change from baseline to peak creatinine Time Frame: Between randomisation and 14 days	Domain-specific outcome for ACE2 RAS Domain	Between randomisation and 14 days
Angioedema Time Frame: Between randomisation and end of study day 12	Domain-specific outcome for ACE2 RAS Domain	Between randomisation and end of study day 12
Change from baseline AST, ALT and bilirubin Time Frame: Between randomisation and 14 days	Domain-specific outcome for ACE2 RAS Domain	Between randomisation and 14 days

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (REMAP-CAP)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

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Phase

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Ages Eligible for Study

Accepts Healthy Volunteers

Description

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Design Details

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Arms and Interventions

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Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

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Publications and helpful links

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Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

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Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

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Plan for Individual participant data (IPD)

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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