Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
Recruiting now · Phase 3
Conditions studied: Ventilator Associated Pneumonia
In brief
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
Key facts
- Study ID
- NCT05696093
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 628
- Starts
- 2023-10-19
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Réanimation Médicale - Hôpital de la Pitié Salpêtrière — Paris, France (enrolling)
- Réanimation Médicale - Hôpital Européen Georges Pompidou — Paris, France (enrolling)
- Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry — Béthune, France
- Réanimation Médico-chirurgicale - Hôpital Avicenne — Bobigny, France
- Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin — Bordeaux, France
- Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré — Boulogne-Billancourt, France
- Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet — Cholet, France
- Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied — Clermont-Ferrand, France
- Médecine Intensive Réanimation - Hôpital Louis Mourier — Colombes, France
- Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien — Corbeil-Essonnes, France
- Médecine Intensive Réanimation - Hôpital François Mitterrand — Dijon, France
- Réanimation Polyvalente - Centre Hospitalier Annecy Genevois — Épagny, France
- Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée — La Roche-sur-Yon, France
- Médecine Intensive Réanimation - Hôpital Michallon — La Tronche, France
- Réanimation Médicale - Hôpital Robert Salengro — Lille, France
- Réanimation médicale - Centre Hospitalier de Longjumeau — Longjumeau, France
- Réanimation et Surveillance continue - Centre Hospitalier de Melun — Melun, France
- Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois — Nancy, France
- Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec — Nantes, France
- Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière — Paris, France
- Centre Hospitalier Intercommunal Saint-Germain-en-Laye — Poissy, France
- Médecine Intensive Réanimation - Hôpital René Dubos — Pontoise, France
- Médecine Intensive Réanimation - Centre Hospitalier Léon Binet — Provins, France
- Médecin Intensive Réanimation - Hôpital Delafontaine — Saint-Denis, France
- Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne — Saint-Priest-en-Jarez, France
Full record on ClinicalTrials.gov
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