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NCT05696093
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
Conditions: Ventilator Associated Pneumonia
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 628
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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
Eligibility Criteria
Inclusion Criteria:Adult patients hospitalized in an ICUUnder mechanical ventilation for at least five daysMicrobiologically confirmed VAP on a distal lung sample (bronchoalveolar lavage or protected distal specimen)Enterobacteriaceae susceptible to cotrimoxazole, and for polymicrobial VAP, all bacteria susceptible to cotrimoxazoleExclusion Criteria:Haemodynamic instability (increasing dose of a catecholamine in the last 24 hours)Contra-indication to cotrimoxazole:allergy,advanced liver insufficiency,renal dysfunction with clearance <15 mL/min/1.73
m² without hemodialysisG6PD deficiencyPregnant women at the time of inclusion and breastfeeding womenInfection requiring prolonged antibiotic-therapy (pleural empyema, lung abscess, necrotizing pneumonia, etc…)Cystic fibrosisImmunosuppression (neutropenia, HIV with CD4 lymphocytes below 200/mm3, immunosuppressive therapy or corticosteroid therapy >0.5 mg/kg/j before ICU admission)Cardiac arrest without awakeningMoribund state (patient likely to die within 24h)Limitation of life support (comfort care applied only) at the time of screeningEnrolment to another interventional study on VAP care/managementSubject deprived of freedom, subject under a legal protective measureNo affiliation to any health insurance systemRefusal to participate to the study (patient or legal representative or family member or close relative if present) Patients previously included in the study
Source: ClinicalTrials.gov (NCT05696093). StuddyBuddy aggregates publicly available trial information.