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
29 juin 2024
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 | Jan HAYON | 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
- 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)
- 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
- 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)
- 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