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

Study acronym: REMAP-CAP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 12, 2024 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 322 to 408
    • Interventions: ARB + DMX-200 (Drug), Amoxicillin-clavulanate (Drug), Anakinra (Drug), Angiotensin Receptor Blockers (Drug), Angiotensin converting enzyme… to ARB + DMX-200 (Drug), Amoxicillin-clavulanate (Drug), Anakinra (Drug), Angiotensin Receptor Blockers (Drug), Angiotensin converting enzyme…
    • Collaborators revised (10)
    v13
  2. Enrollment target: 10000 to 20000
    • Interventions: ARB + DMX-200 (Drug), Amoxicillin-clavulanate (Drug), Anakinra (Drug), Angiotensin Receptor Blockers (Drug), Angiotensin converting enzyme… to ARB + DMX-200 (Drug), Amoxicillin-clavulanate (Drug), Anakinra (Drug), Angiotensin Receptor Blockers (Drug), Angiotensin converting enzyme…
    • Collaborators: 9 to 10
    • Study arms: 16 to 18
    v12
  3. Primary completion date: Dec 2023 to Feb 2026
    • Study completion date: Dec 2025 to Feb 2028
    • Interventions: ARB + DMX-200 (Drug), Amoxicillin-clavulanate (Drug), Anakinra (Drug), Angiotensin Receptor Blockers (Drug), Angiotensin converting enzyme… to ARB + DMX-200 (Drug), Amoxicillin-clavulanate (Drug), Anakinra (Drug), Angiotensin Receptor Blockers (Drug), Angiotensin converting enzyme…
    • Study arms: 15 to 16
    v11
  4. Phase: Phase 4 to Phase 3v10 Show 8 more changesShow less
    • Lead sponsor: MJM Bonten to UMC Utrecht
    • Primary completion date: Dec 2021 to Dec 2023
    • Enrollment target: 7100 to 10000
    • Study sites: 90 to 322
    • Study completion date: Dec 2023 to Dec 2025
    • Interventions: Amoxicillin-clavulanate (Drug), Anakinra (Drug), Apremilast (Drug), Aspirin (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Clopidogrel… to ARB + DMX-200 (Drug), Amoxicillin-clavulanate (Drug), Anakinra (Drug), Angiotensin Receptor Blockers (Drug), Angiotensin converting enzyme…
    • Collaborators: 6 to 9
    • Study arms: 38 to 15
  5. Interventions: Amoxicillin-clavulanate (Drug), Anakinra (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Convalescent plasma (Drug), Five-days oseltamivir… to Amoxicillin-clavulanate (Drug), Anakinra (Drug), Apremilast (Drug), Aspirin (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Clopidogrel…
    • Study arms: 33 to 38
    v9
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  1. Primary endpoints revised (2)v8 Show 5 more changesShow less
    • Study sites: 89 to 90
    • Interventions: Amoxicillin-clavulanate (Drug), Anakinra (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Five-days oseltamivir (Drug), Fixed-duration… to Amoxicillin-clavulanate (Drug), Anakinra (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Convalescent plasma (Drug), Five-days oseltamivir…
    • Eligibility criteria shortened, about 88 words
    • Study description expanded, about 153 words
    • Study arms: 23 to 33
  2. Enrollment target: 6800 to 7100v7 Show 7 more changesShow less
    • Study completion date: Jun 2022 to Dec 2023
    • Interventions: Amoxicillin-clavulanate (Drug), Anakinra (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Five-days oseltamivir (Drug), Fixed-duration… to Amoxicillin-clavulanate (Drug), Anakinra (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Five-days oseltamivir (Drug), Fixed-duration…
    • Eligibility criteria expanded, about 195 words
    • Secondary endpoints: 10 to 11
    • Site details revised at 13 of 89 sites
    • Collaborators: 4 to 6
    • Study arms: 20 to 23
  3. Primary endpoints: 1 to 2v6 Show 7 more changesShow less
    • Study sites: 37 to 89
    • Interventions: Amoxicillin Clavulanate (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Hydrocortisone (Drug), Macrolide administered for 3 days (Drug)… to Amoxicillin-clavulanate (Drug), Anakinra (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Five-days oseltamivir (Drug), Fixed-duration…
    • Secondary endpoints: 7 to 10
    • Study description expanded, about 49 words
    • Collaborators: 3 to 4
    • Study arms: 9 to 20
    • Eligibility criteria expanded, about 2 words
  4. Study sites: 36 to 37v5
  5. Lead sponsor: UMC Utrecht to MJM Bontenv4 Show 12 more changesShow less
    • Enrollment target: 4000 to 6800
    • Primary completion date: Feb 2019 to Dec 2021
    • Start date: Dec 2015 to Apr 11, 2016
    • Primary endpoint revised
    • Study sites: 5 to 36
    • Study completion date: Feb 2019 to Jun 2022
    • Interventions: Antibiotic A (Drug), Antibiotic B (Drug), ECCO2R (Device), Hydrocortisone (Drug), Maximal recruitment (Device), Minimal distension (Device) to Amoxicillin Clavulanate (Drug), Ceftaroline (Drug), Ceftriaxone (Drug), Hydrocortisone (Drug), Macrolide administered for 3 days (Drug)…
    • Eligibility criteria shortened, about 193 words
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 77 words
    • Collaborators expanded, about 16 words
    • Study arms: 12 to 9
  6. Study title revisedv3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02735707
Lead Sponsor UMC Utrecht
Collaborators: Australian and New Zealand Intensive Care Research Centre, Medical Research Institute of New Zealand, Unity Health, Berry Consultants, Global Coalition for Adaptive Research, University of Pittsburgh Medical Center, Intensive Care National Audit & Research Centre, St. Marianna University School of Medicine, Nat Intensive Care Surveillance - MORU, National University Hospital, Singapore
Conditions
(from sponsor)		 Community-acquired Pneumonia, Influenza, COVID-19
Related terms Community-Acquired Pneumonia, COVID-19, Influenza, Human, Lung Diseases, Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov