Status:
RECRUITING
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Australian and New Zealand Intensive Care Research Centre
Medical Research Institute of New Zealand
Conditions:
Community-acquired Pneumonia, Influenza, COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 impro...
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 ...
Eligibility Criteria
Inclusion
- REMAP-CAP PLATFORM INCLUSION CRITERIA:
- Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:
- symptoms or signs or both that are consistent with lower respiratory tract infection AND
- 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:
- Non-invasive or Invasive ventilatory support;
- Receiving infusion of vasopressor or inotropes or both
Exclusion
- Healthcare-associated pneumonia:
- Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
- 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).
Key Trial Info
Start Date :
April 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
20000 Patients enrolled
Trial Details
Trial ID
NCT02735707
Start Date
April 11 2016
End Date
February 1 2028
Last Update
July 12 2024
Active Locations (408)
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1
University of Florida
Jacksonville, Florida, United States, 32209
2
Augusta University
Augusta, Georgia, United States, 30912
3
University of Illinois Health
Chicago, Illinois, United States, 60612
4
Tulane Medical Center
New Orleans, Louisiana, United States, 70112