Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Out-Of-Hospital Cardiac Arrest, Pneumonia
In brief
Randomized-controlled trial and microbiome assessment to understand the risk-to-benefit ratio of prophylactic antibiotics (Ceftriaxone) vs placebo in patients with pneumonia and inflammation after cardiac arrest outside the hospital.
Key facts
- Study ID
- NCT04999592
- Run by
- David J. Gagnon
- People needed
- 53
- Starts
- 2021-08-20
- Expected to finish
- 2024-11-01
- Last updated by the study team
- 2025-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥18 years of age
- Comatose (do not follow simple verbal commands)
- Have any initial heart rhythm (shockable or non-shockable)
- OHCA including the emergency department
You may not qualify if…
- Name on opt-out list
- In-hospital cardiac arrest
- Interval >6 hours from ICU admission to study drug receipt
- Preexisting terminal disease making 180-day survival unlikely
- Refused informed consent
- Emergent coronary artery bypass grafting
- Anaphylaxis or angioedema to beta-lactam antibiotics (i.e., cephalosporins or penicillins)
- Under legal guardianship or prisoner
- Known colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococcus (VRE)
- Clinical bacterial infection prior to hospital admission defined as any one of the following:
- Infectious prodrome preceding OHCA
- Active course of antibiotics for infection prior to admission
- Active infection documented in the electronic medical record
- Family or surrogate endorsement of an active infection
Where it is running
- Maine Medical Center — Portland, Maine, United States
Full record on ClinicalTrials.gov
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