Informations générales (source: ClinicalTrials.gov)
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial (COTRIVAP)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2023
décembre 2026
21 mai 2025
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
Etablissements
Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
AP-HP - Hôpital Ambroise Paré | ROUX Damien | 18/04/2025 07:55:57 | Contacter | ||
AP-HP - Hôpital Avicenne | ROUX Damien | 18/04/2025 07:55:57 | Contacter | ||
AP-HP - Hôpital Europeen Georges Pompidou | ROUX Damien | 18/04/2025 07:55:57 | Contacter | ||
AP-HP - Hôpital La Pitié-Salpêtrière | ROUX Damien | 18/04/2025 07:55:57 | Contacter | ||
AP-HP - Hôpital Louis Mourier | ROUX Damien | 18/04/2025 07:55:57 | Contacter | ||
HOPITAL NOVO | RADJOU Aguila | 14/02/2025 09:03:14 | Contacter | ||
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
CENTRE HOSPITALIER SUD FRANCILIEN | Contact (sur clinicalTrials) | ||||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Centre Hospitalier Intercommunal Saint-Germain-en-Laye - 78003 - Poissy - France | Contact (sur clinicalTrials) | ||||
Médecin Intensive Réanimation - Hôpital Delafontaine - 93200 - Saint-Denis - France | Daniel DA SILVA | Contact (sur clinicalTrials) | |||
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry - 62660 - Béthune - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée - 85000 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Centre Hospitalier Léon Binet - 77160 - Provins - France | Mohamed FEJJAL | Contact (sur clinicalTrials) | |||
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers - 49100 - Angers - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois - 54000 - Nancy - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Hôpital Bretonneau - 37000 - Tours - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Hôpital François Mitterrand - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Hôpital Michallon - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
Médecine Intensive Réanimation - Nouvel Hôpital Civil - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Réanimation et Surveillance continue - Centre Hospitalier de Melun - 77000 - Melun - France | Contact (sur clinicalTrials) | ||||
Réanimation médicale - Centre Hospitalier de Longjumeau - 91160 - Longjumeau - France | Contact (sur clinicalTrials) | ||||
Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied - 63003 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
Réanimation Médicale - Hôpital de la Pitié Salpêtrière - 75013 - Paris - France | Charles Edouard LUYT | Contact (sur clinicalTrials) | |||
Réanimation Médicale - Hôpital Robert Salengro - 59037 - Lille - France | Saad NSEIR | Contact (sur clinicalTrials) | |||
Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec - 44093 - Nantes - France | Karim LAKHAL | Contact (sur clinicalTrials) | |||
Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré - 92100 - Boulogne-Billancourt - France | Contact (sur clinicalTrials) | ||||
Réanimation Polyvalente - Centre Hospitalier Annecy Genevois - 74370 - Épagny - France | Noémie ZUCMAN | Contact (sur clinicalTrials) | |||
Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne - 42270 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
Réanimation Polyvalente - Hôpital Sainte Musse - 83056 - Toulon - France | Contact (sur clinicalTrials) | ||||
Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet - 49300 - Cholet - France | Contact (sur clinicalTrials) |
Critères
Tous
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
- 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
- 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