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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Out-Of-Hospital Cardiac Arrest Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The clinical team responsible for the participant (physicians, nurses and others) and involved with direct patient care will be blinded. Investigators will be blinded and the placebo will match the study drug. Outcomes Assessors will be blinded to treatment assignment during assessments of pneumonia and functional outcome.

Study Groups

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No prophylaxis (placebo)

Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted.

Administer antibiotics in response to infection.

Group Type ACTIVE_COMPARATOR

Standard of care without prophylaxis

Intervention Type DRUG

Administer antibiotics in response to infection

Prophylaxis

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

Group Type EXPERIMENTAL

Antibiotic prophylaxis

Intervention Type DRUG

Ceftriaxone 2 gm IV q12h for 3 days

Interventions

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Standard of care without prophylaxis

Administer antibiotics in response to infection

Intervention Type DRUG

Antibiotic prophylaxis

Ceftriaxone 2 gm IV q12h for 3 days

Intervention Type DRUG

Other Intervention Names

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Placebo Rocephin (ceftriaxone)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No