Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David J. Gagnon
• Collaborators: MaineHealth; National Institute of General Medical Sciences (NIGMS); University of New England
• Treatments: Anti-Bacterial Agents

Criteria

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• 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