NCT05696093 Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
| NCT ID | NCT05696093 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Ventilator Associated Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 628 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 628 participants in total. It began in 2023-10-19 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 * 5\) Treated for at least 24 hours by an appropriate empiric antibiotic therapy (at least one effective antibiotic from the initiation of treatment for this VAP episode), and for polymicrobial VAP, all bacteria susceptible to empiric antibiotic therapy * Stability of haemodynamic (stability or decrease in catecholamine dose) and respiratory (stability or improvement of FIO2) parameters Exclusion 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 hemodialysis * G6PD deficiency * history of hypersensitivity to one of the components (in particular, hypersensitivity to sulphonamides * known macrocytic anemia defined by VGM \> * treatment with methotrexate * Infection requiring prolonged antibiotic-therapy (pleural empyema, lung abscess, necrotizing pneumonia, etc…) * Cystic fibrosis * Immunosuppression (neutropenia, HIV with CD4 lymphocytes below 200/mm3, immunosuppressive therapy or corticosteroid therapy \>0.5 mg/kg/j before ICU admission) * Cardiac arrest without awakening * Moribund state (patient likely to die within 24h) * Limitation of life support (comfort care applied only) at the time of screening * Enrolment to another interventional study on VAP care/management * Pregnancy or breastfeeding * Subject deprived of freedom, subject under a legal protective measure * No affiliation to any health insurance system * Refusal to participate to the study (patient or legal representative or family member or close relative if present) * Patients previously included in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05696093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventilator Associated Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05696093 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 628 participants.
Is NCT05696093 currently recruiting?
Yes, NCT05696093 is actively recruiting participants. Contact the research team at damien.roux@aphp.fr for enrollment information.
Where is the NCT05696093 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Béthune, France, Bobigny, France and 11 additional locations.
Who is sponsoring the NCT05696093 clinical trial?
NCT05696093 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 628 participants.