Adaptive trial in severe pneumonia (REMAP-CAP)

Phase 1

• Conditions: Severe Community Acquired PneumoniaCOVID-19Influenza; MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002340-14-DE
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Last Update Posted: 7 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

General REMAP-CAP Inclusion Criteria:
1. Adult (=18 years of age) patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with:
a. symptoms or signs or both that are consistent with lower respiratory tract infection AND
b.Radiological evidence of new onset infiltrate of infective origin (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:
a. Non-invasive or invasive ventilatory support;
b.Receiving infusion of vasopressor or inotropes or both

COVID-19:
In order to be eligible to participate in the pandemic aspects of REMAP-CAP, a patient must meet the following criteria:
1. Adult patient admitted to hospital with acute illness due to suspected or proven pandemic infection.

This extension of the platform-level inclusion criteria can apply to patients admitted to an ICU or a ward. In association with the involvement of different clinical teams, the domains and interventions that are available for patients admitted to a ward compared with those admitted to an ICU are permitted to be, but do not have to be, different.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5000

Exclusion Criteria

General REMAP-CAP Exclusion Criteria:
1.Healthcare-associated pneumonia:
a.Prior to this illness, has been an inpatient in any healthcare facility within the last 30 days
b.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 (This applies to Germany: A patient who has been enrolled previously in REMAP-CAP is not eligible for re-enrolment in any second or subsequent episode of CAP.)

There are domain-specific exclusion criteria in the Antibiotic, macrolide duration, corticosteroid, antiviral, mechanical Ventilation and Anticoagulation domains. Due to maximum number of characters, these are not listed separately.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified