Testing Cotrimoxazole Versus Standard Antibiotics for Ventilator-Associated Pneumonia in ICU Adults A Multicenter Randomized Phase 3 Trial

What this Trial Is About

Researchers are evaluating the effectiveness of cotrimoxazole compared to standard antibiotic therapy for treating ventilator-associated pneumonia VAP caused by Enterobacteriaceae in adult patients in intensive care units ICU. This multicenter randomized trial aims to determine if cotrimoxazole is not inferior to the best standard care in terms of survival 28 days after treatment begins. Patients with confirmed VAP and susceptibility to cotrimoxazole are included, with specific attention to those with or without septic shock and COVID-19 pneumonia. Participants are randomly assigned to receive either cotrimoxazole or standard antibiotic treatment, such as beta-lactams or fluoroquinolones, for a total of 7 days including initial empiric treatment. The antibiotic dosing and administration are adjusted based on current ICU recommendations. The treatment period can last up to 28 days or until death or ICU discharge if earlier. The study is not blinded due to variable therapies in the control group. During the study, patients are monitored daily until death, ICU discharge, or day 28 for vital signs, antibiotic use, new infections, and Clostridium difficile infection. Clinical and radiological evaluations occur at day 7, and weekly screening for multidrug-resistant bacteria is performed. Survival status is followed up to 90 days through phone or hospital interview. An independent committee reviews clinical and radiological outcomes without knowledge of treatment assignment to ensure unbiased assessment.

Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit