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

Last updated: April 16, 2025
Sponsor: David J. Gagnon
Overall Status: Terminated

Phase

2

Condition

Pneumonia

Treatment

Antibiotic prophylaxis

Standard of care without prophylaxis

Clinical Study ID

NCT04999592
1P20GM139745-01
P20GM139745
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 orpenicillins)

  • Under legal guardianship or prisoner

  • Known colonization with methicillin-resistant Staphylococcus aureus (MRSA) orvancomycin-resistant enterococcus (VRE)

  • Clinical bacterial infection prior to hospital admission defined as any one of thefollowing:

  • 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

Study Design

Total Participants: 53
Treatment Group(s): 2
Primary Treatment: Antibiotic prophylaxis
Phase: 2
Study Start date:
August 20, 2021
Estimated Completion Date:
November 01, 2024

Study Description

Pneumonia is an infection of the lungs resulting in alveolar inflammation and fluid or purulent material accumulation. It is the most common infection after cardiac arrest occurring in up to 65% of patients treated with targeted temperature management. Pneumonia may result from aspiration during cardiopulmonary resuscitation (CPR), or by introduction of oropharyngeal flora into the lungs during airway management. Preventing infection after OHCA may: 1) reduce exposure to broad-spectrum antibiotics and subsequent collateral damage, 2) prevent hemodynamic derangements due to local and systemic inflammation, and 3) prevent an association between infection and morbidity and mortality. These benefits must be balanced with the risk for altering bacterial resistomes in the absence clinical infection. Accordingly, further study is warranted to understand the risk-to-benefit ratio of prophylactic antibiotics.

Connect with a study center

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

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