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

David J. Gagnon

Status and phase: Terminated; Phase 2

Conditions: Out-Of-Hospital Cardiac Arrest; Pneumonia

Treatments: Drug: Antibiotic prophylaxis; Drug: Standard of care without prophylaxis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04999592

1P20GM139745-01

P20GM139745 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups

No prophylaxis (placebo)

Active Comparator group

Description:

Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted. Administer antibiotics in response to infection.

Treatment:

Drug: Standard of care without prophylaxis

Prophylaxis

Experimental group

Description:

Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days.

Treatment:

Drug: Antibiotic prophylaxis