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

Grippe humaine
Maladies pulmonaires
Pneumopathie infectieuse
Maladies de l'appareil respiratoire
Infections de l'appareil respiratoire

Phase

Phase 3

Promoteur

UMC Utrecht (Voir sur ClinicalTrials)

Date de début

avril 2016

Date de fin

février 2029

Dernière mise à jour

05 novembre 2026

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 hospitalised patients admitted to intensive care with respiratory tract infections. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.

Détail

Voir le détail Background: Respiratory tract infections that are of sufficient severity to require admission to hospital are associated with substantial mortality. All hospitalized patients with respiratory tract infections will receive therapy that consists of a combination of multiple different treatments. For many of these treatments, different options are available currently. For example, several antibiotics exist that are active against the microorganisms that commonly cause pneumonia but it is not known if one antibiotic strategy is best, or whether all suitable antibiotic strategies have similar levels of effectiveness. Of all the treatments that clinicians use for patients with respiratory tract infections, only a small minority have been tested in randomized controlled trials to determine their comparative effectiveness. As a consequence, the standard treatments that are administered vary between and within countries. Current conventional clinical trials methods to assess the efficacy of treatments for respiratory tract infections generally compare two treatment options (either two options for the same treatment modality, where both are in common use; or a new treatment against no treatment or placebo, where the effectiveness of the new treatment is not known). Using this approach, in a series of separate and sequential trials, it will take an inordinate length of time to study all the treatment options. Additionally, with conventional trial designs it is not possible to evaluate interactions between treatment options. Aim: The primary objective of this platform trial is, for patients hospitalized with respiratory tract infection, to identify the effect of a range of interventions to improve patient outcomes. Methods: The study will enroll hospitalized patients with respiratory tract infection using a trial design known as a REMAP, which is a type of platform trial. Within this platform trial, eligible participants will be randomized to receive one intervention in each of one or more domains. The primary outcome is a composite of 90-day all-cause mortality and, among survivors, a daily ordinal scale analyzed as a trajectory of illness and recovery to 28-days. There will also be both Platform and domain-specific secondary outcome measures. In a conventional trial enrollment continues until a pre-specified sample size is obtained, at which time enrollment ceases and the trial data are analyzed to obtain a result. The possible results are that a difference is detected, or no that no difference is detected. However, when the conclusion of the statistical test is "no difference", this could reflect that there truly is no meaningful difference or that the result is indeterminate (i.e., it is possible that if more patients had been enrolled a clinically relevant difference may have been detected). In comparison to a conventional trial this Platform uses an adaptive design that: - avoids indeterminate results by concluding an answer to a question when sufficient data have accrued (not when a pre-specified sample is reached); - utilizes already accrued data to increase the likelihood that patients within the trial are more likely to be randomized to treatments that are more likely to be beneficial; - is intended to be perpetual (or at least open-ended), substituting new questions in series as initial questions are answered; and - can evaluate the interaction between interventions in different domains, added at different timepoints into the Platform. Bayesian statistical methods will be used to define Statistical Triggers that reflect thresholds for decision making within a domain. While a limited number of initial treatments and treatment domains were specified at initiation, other interventions and domains have been evaluated over time, and it is planned that this platform trial will continue to evaluate other treatments in the future. Furthermore, in the event of a future epidemic, this Platform is able to adapt to evaluate the most relevant treatment options. 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	27/12/2025 07:34:14	Contacter
CH DE MELUN SITE SANTEPOLE	ANNANE Djillali	En recrutement IDF	27/12/2025 07:34:12	Contacter
CH SUD ESSONNE-DOURDAN-ETAMPES	ANNANE Djillali	En recrutement IDF	27/12/2025 07:34:14	Contacter
GHEM SIMONE VEIL SITE EAUBONNE	ANNANE Djillali	En recrutement IDF	27/12/2025 07:34:15	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	27/12/2025 07:34:16	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

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

- All Platform inclusion criteria are met

- None of the Platform exclusion criteria are met

- Domain-specific eligibility criteria are met

- The patient is eligible for at least two interventions within a domain

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

--

PLATFORM INCLUSION CRITERIA:

1. Hospitalised patient

2. Acute respiratory tract infection

3. Aged 28 days or older

PLATFORM EXCLUSION CRITERIA:

1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or
more of the patient, substitute decision maker or attending physician are not
committed to full active treatment

2. Patient is expected to be discharged from hospital within the next 24 hours

3. Previous participation in this REMAP within the last 90 days

DOMAIN-SPECIFIC ELIGIBILITY CRITERIA:

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

Critère de non inclusion

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

Informations générales
Etablissements
Critères
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