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

Phase 4

Recruiting

Conditions: COVID-19
infection involving the lungs
influenza
pneumonia
10021879
10024970

Registration Number: NL-OMON53023

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

General REMAP-CAP:
1. Adult 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

For the COVID-19 domains:
1. COVID-19 infection is suspected by the treating clinician or has been
confirmed by microbiological testing (i.e. PISOP stratum)
2. Microbiological testing for SARS-CoV-2 infection of upper or lower
respiratory tract secretions or both has occurred or is intended to occur

If applicable, domain and/or intervention-specific inclusion criteria listed in
the DSA.

Exclusion Criteria

General REMAP-CAP Exclusion Criteria:
1. Healthcare-associated pneumonia:
a. Prior to this illness, is known to have 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

For subjects suspected or proven to have COVID-19, the 48 hour time window does
not apply, due to the nature of the disease process.

There are specific exclusion criteria (if needed) for every domain or
intervention within a domain in the trial, listed in each DSA.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint outside a pandemic is mortality at day 90 censored at<br /><br>hospital discharge.<br /><br>In case of a pandemic, this is retained as a secondary endpoint, and a new<br /><br>pandemic primary endpoint is added: days alive and without organ support at<br /><br>day 21, where all subjects deceased before the end of follow up will be<br /><br>denoted as -1 at that time.</p><br>

Secondary Outcome Measures