Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT02735707 En recrutement IDF

Titre

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Type

Interventional

Pathologie

Pneumopathie infectieuse

Phase

Phase 3

Promoteur

UMC Utrecht (Voir sur ClinicalTrials)

Date de début

avril 2016

Date de fin

février 2028

Dernière mise à jour

13 septembre 2025

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CH VICTOR DUPOUY ARGENTEUIL	ANNANE Djillali	En recrutement IDF	01/11/2025 07:48:48	Contacter
CH DE MELUN SITE SANTEPOLE	ANNANE Djillali	En recrutement IDF	01/11/2025 07:48:46	Contacter
CH SUD ESSONNE-DOURDAN-ETAMPES	ANNANE Djillali	En recrutement IDF	01/11/2025 07:48:48	Contacter
GHEM SIMONE VEIL SITE EAUBONNE	ANNANE Djillali	En recrutement IDF	01/11/2025 07:48:49	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	01/11/2025 07:48:50	Contacter
	AP-HP - Hôpital Ambroise Paré
	AP-HP - Hôpital Cochin
	AP-HP - Hôpital Lariboisiere-Fernand Widal
	AP-HP - Hôpital Raymond Poincaré
	AP-HP - Hôpital Tenon
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Beauvais General Hospital - 60000 - Beauvais - France		Active, sans recrutement		Contact (sur clinicalTrials)
Centre hospitalier Bethune Beuvry - 62660 - Béthune - France	Christophe Vinsonneau, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier de Dieppe - 76202 - Dieppe - France	Peierre-Louis Declercq, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier de Melun - 77000 - Melun - France		Active, sans recrutement		Contact (sur clinicalTrials)
Centre Hospitalier des Pays de Morlaix - 29600 - Morlaix - France	Pierre Yves Egreteau, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Henri Mondor d'Aurillac - 15000 - Aurillac - France		Complet		Contact (sur clinicalTrials)
Centre Hospitalier Layne - Mont-de-Marsan - 40024 - Mont-de-Marsan - France	Arnaud Sement, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Le Mans - 72027 - Le Mans - France	Christophe Guitton, MD	En recrutement		Contact (sur clinicalTrials)
CH Argenteuil - 95107 - Argenteuil - France		Active, sans recrutement		Contact (sur clinicalTrials)
CH de Dax - 40100 - Dax - France	Adrien Auvet, MD	En recrutement		Contact (sur clinicalTrials)
CHD Vendee - 85000 - La Roche-sur-Yon - France	Gwenael Colin, MD	En recrutement		Contact (sur clinicalTrials)
CHR d'Orleans - 45100 - Orléans - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHRU Tours Hopital Bretonneau - 37000 - Tours - France	Emmanuelle Mercier, MD	En recrutement		Contact (sur clinicalTrials)
CHU Dijon Bourgogne - 21000 - Dijon - France	Jean-Pierre Quenot, MD	En recrutement		Contact (sur clinicalTrials)
CHU Dupuytren - 87000 - Limoges - France	Francois Bruno, MD	En recrutement		Contact (sur clinicalTrials)
Hopital de Hautepierre Strasbourg - 67200 - Strasbourg - France		Active, sans recrutement		Contact (sur clinicalTrials)
Hopital Nord Franche-Comte - 90400 - Belfort - France		Suspendu		Contact (sur clinicalTrials)
Hopital Simone Veil Eaubonne - 95600 - Eaubonne - France		Active, sans recrutement		Contact (sur clinicalTrials)
Nouvel Hopital Civil Strasbourg - 67000 - Strasbourg - France	Ferhat Meziani, MD	En recrutement		Contact (sur clinicalTrials)
Sud Essonne Hospital Etampes - 91150 - Étampes - France		Active, sans recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

INCLUSION CRITERIA:

1. 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)

2. 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

Critère de non inclusion

1. 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

2. 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

3. 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

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 today or tomorrow

3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute
illness due to suspected or proven pandemic infection.

4. 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).

NCT02735707 - Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Informations générales
Etablissements
Critères
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