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Recruiting Phase 3

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

NCT05696093 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2023-10-19
Last updated
2025-05-20

Condition(s) studied

Ventilator Associated Pneumonia

Investigational drug(s) / intervention(s)

cotrimoxazolestandard antibiotic therapy

cotrimoxazole: Use of cotrimoxazole therapy for enterobacterial VAP

standard antibiotic therapy: Use of standard antibiotic therapy for enterobacterial VAP

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — 28 days after inclusion
    Vital status at day 28

Trial sites (30)

FacilityCityRegionStatus
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie Amiens France Active Not Recruiting
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers Angers France Active Not Recruiting
Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry Béthune France Active Not Recruiting
Réanimation Médico-chirurgicale - Hôpital Avicenne Bobigny France Not Yet Recruiting
Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin Bordeaux France Active Not Recruiting
Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré Boulogne-Billancourt France Active Not Recruiting
Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet Cholet France Active Not Recruiting
Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied Clermont-Ferrand France Active Not Recruiting
Médecine Intensive Réanimation - Hôpital Louis Mourier Colombes France Active Not Recruiting
Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien Corbeil-Essonnes France Active Not Recruiting
Médecine Intensive Réanimation - Hôpital François Mitterrand Dijon France Active Not Recruiting
Réanimation Polyvalente - Centre Hospitalier Annecy Genevois Épagny France Not Yet Recruiting
Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée La Roche-sur-Yon France Active Not Recruiting
Médecine Intensive Réanimation - Hôpital Michallon La Tronche France Active Not Recruiting
Réanimation Médicale - Hôpital Robert Salengro Lille France Not Yet Recruiting
Réanimation médicale - Centre Hospitalier de Longjumeau Longjumeau France Active Not Recruiting
Réanimation et Surveillance continue - Centre Hospitalier de Melun Melun France Active Not Recruiting
Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois Nancy France Active Not Recruiting
Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec Nantes France Not Yet Recruiting
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière Paris France Active Not Recruiting
Réanimation Médicale - Hôpital de la Pitié Salpêtrière Paris France Recruiting
Réanimation Médicale - Hôpital Européen Georges Pompidou Paris France Recruiting
Centre Hospitalier Intercommunal Saint-Germain-en-Laye Poissy France Active Not Recruiting
Médecine Intensive Réanimation - Hôpital René Dubos Pontoise France Active Not Recruiting
Médecine Intensive Réanimation - Centre Hospitalier Léon Binet Provins France Not Yet Recruiting
Médecin Intensive Réanimation - Hôpital Delafontaine Saint-Denis France Not Yet Recruiting
Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne Saint-Priest-en-Jarez France Active Not Recruiting
Médecine Intensive Réanimation - Nouvel Hôpital Civil Strasbourg France Active Not Recruiting
Réanimation Polyvalente - Hôpital Sainte Musse Toulon France Active Not Recruiting
Médecine Intensive Réanimation - Hôpital Bretonneau Tours France Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05696093 on ClinicalTrials.gov ↗ ← All trials in France