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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
53
Administer antibiotics in response to infection
Ceftriaxone 2 gm IV q12h for 3 days
Maine Medical Center
Portland, Maine, United States
Clinically-diagnosed Early-onset Pneumonia
Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia occurring \<4 days after initiation of mechanical ventilation
Time frame: 4 days
Microbiologically-confirmed Early-onset Pneumonia
Percentage of Participants with Microbiologically-confirmed Early-onset Pneumonia occurring \<4 days after initiation of mechanical ventilation
Time frame: 4 days
Microbiologically-confirmed Late-onset Pneumonia
Percentage of Participants with Microbiologically-confirmed late-onset pneumonia occurring ≥4 days after initiation of mechanical ventilation
Time frame: ≥ 4 days
Clinically-diagnosed Late-onset Pneumonia
Percentage of Participants with Clinically-diagnosed late-onset pneumonia occurring ≥4 days after initiation of mechanical ventilation
Time frame: ≥ 4 days
Non-pulmonary Infections
Percentage of Participants with non-pulmonary infections
Time frame: During the intervention and immediately after the intervention until hospital discharge, up to 6 months
ICU-free Days During Admission
ICU-free days in the first 28 days of admission
Time frame: 28 days
Mechanical Ventilator-free Days During Admission
Mechanical ventilator-free days in the first 28 days of admission
Time frame: 28 days
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Death in the Hospital
Percentage of Participants who Die in the Hospital during admission
Time frame: During the intervention (3 days) and immediately after the intervention until subject death or hospital discharge, an average of 30 days
Functional Outcome at 6 Months Post-hospital Discharge
Median mRS (0 as no residual symptoms and 6 as death) at 6 Months Post-hospital Discharge
Time frame: 6 months post-hospital discharge
Clostridioides Difficile-associated Diarrhea
Percentage of Participants with Clostridioides difficile-associated Diarrhea
Time frame: During the intervention and immediately after the intervention until death or hospital discharge
Type One Hypersensitivity Reactions
Percentage of Participants with Type One (immediate-type) hypersensitivity reactions
Time frame: Three days
Participants With Gallbladder Disease
Percentage of Participants with Gallbladder disease
Time frame: During the intervention and immediately after the intervention until death or hospital discharge