RECRUITING
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Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)
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.
Conditions:
🦠 Out-Of-Hospital Cardiac Arrest 🦠 Pneumonia
🗓️ Study Start (Actual) 20 August 2021
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 30 June 2024
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Portland, Maine, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 July 2021
  • First Submitted that Met QC Criteria 2 August 2021
  • First Posted 11 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 October 2023
  • Last Update Posted 3 October 2023
  • Last Verified October 2023
I'm interested ...!!