Skip to content

COTRIVAP - Efficacy of cotrimoxazole as a de-escalation treatment of Ventilator-Associated Pneumonia in intensive care unit. Multicentric non-inferiority randomised controlled trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505108-52-00
Acronym
APHP220799
Enrollment
628
Registered
2023-07-20
Start date
2023-12-20
Completion date
2025-09-19
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care, Ventilator-associated Pneumonia

Brief summary

vital status at day 28

Detailed description

vital status at day 28, number of mechanical ventilation-free-days from inclusion to day 28 or death., 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), new episode of VAP with the same Enterobacteriaceae, ICU length of stay, hospital length of stay, number of antibiotic free-days from inclusion to day 28 or death., safety (rate of allergy due to antimicrobial drug), ecological impact: o evolution of rate of MDR bacterial colonization on systematic screening at enrolment until ICU discharge, diagnostic of Clostridioides difficile infection between inclusion and day 28, Vital Status at day 90

Interventions

DRUGIMIPENEM MONOHYDRATE
DRUGMEROPENEM
DRUGCEFEPIME
DRUGLEVOFLOXACIN
DRUGCIPROFLOXACIN
DRUGAMOXICILLIN
DRUGERTAPENEM
DRUGCEFTRIAXONE
DRUGCEFOTAXIME

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
vital status at day 28

Secondary

MeasureTime frame
vital status at day 28, number of mechanical ventilation-free-days from inclusion to day 28 or death., 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), new episode of VAP with the same Enterobacteriaceae, ICU length of stay, hospital length of stay, number of antibiotic free-days from inclusion to day 28 or death., safety (rate of allergy due to antimicrobial drug), ecological impact: o evolution of rate of MDR bacterial colonization on systematic screening at enrolment until ICU discharge, diagnostic of Clostridioides difficile infection between inclusion and day 28, Vital Status at day 90

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026