Efficacy of cotrimoxazole as a de-escalation treatment for adult patients Ventilator-Associated Pneumonia in intensive care unit Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP
Adult patients hospitalized in an ICU
Under mechanical ventilation for at least five days
Microbiologically confirmed VAP preferably on a distal lung sample (bronchoalveolar lavage or protected distal specimen) otherwise endotracheal aspiration
Enterobacteriaceae susceptible to cotrimoxazole, and for polymicrobial VAP, all bacteria susceptible to cotrimoxazole
Haemodynamic instability (increasing dose of a catecholamine in the last 24 hours)
allergy,
advanced liver insufficiency,
renal dysfunction with clearance <15 mL/min/1.73 m² without hemodialysis
Parallel
cotrimoxazole
DrugUse of cotrimoxazole therapy for enterobacterial VAP
standard antibiotic therapy
DrugUse of standard antibiotic therapy for enterobacterial VAP
To demonstrate that cotrimoxazole is non-inferior to best standard of care for the treatment of VAP in ICU in term of survival at day 28
Vital status at day 28
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in term of mortality at day 90
Vital status at day 90
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in IC in terms of mechanical ventilation (MV)-free-days at day 28
number of MV-free-days through day 28
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of rate of cure between days 7 and 10
Clinical, biological and radiological cure evaluated 7 to 10 days after VAP diagnosis, defined as the combination of resolution of signs and symptoms present at enrolment, biological improvement, and improvement or lack of progression of radiological signs, as adjudicated by an independent committee (PROBE methodology)
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of VAP recurrence
new episode of VAP with the same Enterobacteriaceae
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