Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05696093 En recrutement IDF

Titre

Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial (COTRIVAP)

Type

Interventional

Pathologie

Pneumopathie infectieuse
Pneumopathie infectieuse sous ventilation assistée

Phase

Phase 3

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

octobre 2023

Date de fin

décembre 2026

Dernière mise à jour

29 juin 2024

Résumé

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

Détail

Voir le détail Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP. Selection of patients will be done by physicians in ICU. All clinically suspected VAP will be confirmed with a lung sample (preferably bronchoalveolar lavage or protected distal specimen, otherwise endotracheal aspiration). Patients with a microbiologically confirmed VAP due to an Enterobacteriaceae susceptible to cotrimoxazole and at least one antibiotic of the empiric antibiotic therapy (based on international recommendations) will be included. After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by presence of septic shock at VAP diagnosis and by presence of COVID-19 pneumonia on ICU admission, through a centralized 24 hours internet service (CleanWEB™) to cotrimoxazole, or best standard of care (either a beta-lactam or a fluoroquinolone), after randomization for a total duration of 7 days (including empiric initial appropriate treatment). Posology and modalities of antibiotic administration will be optimized based on most recent recommendations for ICU patients. Because antibiotic therapy will be variable in the control group, single or double blind is not appropriate. Daily follow-up until death or ICU discharge or day 28 will be performed (vital status, antibiotic therapy, new infection, Clostridium-difficile infection). Clinical (arterial blood gas, temperature, haematology, tracheal secretions) and radiological cure (chest X-ray) will be assessed at Day 7. Systematic MDR bacteria screening will be performed weekly and at ICU discharge. Vital status will be assessed at day 90. Alive patients leaving ICU before 90 days will be contacted by phone (if discharge at home) or by interview at hospital (if transferred in a different ward). Assessment of the clinical and radiological cure by an independent committee (1 specialist in infectious disease and 1 intensivist), blinded of the randomization arm (PROBE methodology). Fermer le détail

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	En recrutement IDF	12/04/2024 09:28:16	Contacter
AP-HP - Hôpital Avicenne	ROUX Damien	En recrutement IDF	12/04/2024 09:28:16	Contacter
AP-HP - Hôpital Europeen Georges Pompidou	ROUX Damien	En recrutement IDF	12/04/2024 09:28:16	Contacter
AP-HP - Hôpital La Pitié-Salpêtrière	ROUX Damien	En recrutement IDF	12/04/2024 09:28:16	Contacter
AP-HP - Hôpital Louis Mourier	ROUX Damien	En recrutement IDF	12/04/2024 09:28:16	Contacter
HOPITAL NOVO	RADJOU	En recrutement IDF	04/07/2024 11:04:57	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		Active, sans recrutement		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	Recrutement non commencé		Contact (sur clinicalTrials)
Médecin Intensive Réanimation - Hôpital Delafontaine - 93200 - Saint-Denis - France	Daniel DA SILVA	Recrutement non commencé		Contact (sur clinicalTrials)
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière - 75013 - Paris - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry - 62660 - Béthune - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée - 85000 - La Roche-sur-Yon - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Centre Hospitalier Léon Binet - 77160 - Provins - France	Mohamed FEJJAL	Recrutement non commencé		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie - 80054 - Amiens - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers - 49100 - Angers - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois - 54000 - Nancy - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin - 33000 - Bordeaux - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Hôpital Bretonneau - 37000 - Tours - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Hôpital François Mitterrand - 21079 - Dijon - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Hôpital Michallon - 38700 - La Tronche - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Intensive Réanimation - Nouvel Hôpital Civil - 67091 - Strasbourg - France		Active, sans recrutement		Contact (sur clinicalTrials)
Réanimation et Surveillance continue - Centre Hospitalier de Melun - 77000 - Melun - France		Active, sans recrutement		Contact (sur clinicalTrials)
Réanimation médicale - Centre Hospitalier de Longjumeau - 91160 - Longjumeau - France		Active, sans recrutement		Contact (sur clinicalTrials)
Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied - 63003 - Clermont-Ferrand - France		Active, sans recrutement		Contact (sur clinicalTrials)
Réanimation Médicale - Hôpital de la Pitié Salpêtrière - 75013 - Paris - France	Charles Edouard LUYT	En recrutement		Contact (sur clinicalTrials)
Réanimation Médicale - Hôpital Robert Salengro - 59037 - Lille - France	Saad NSEIR	Recrutement non commencé		Contact (sur clinicalTrials)
Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec - 44093 - Nantes - France	Karim LAKHAL	Recrutement non commencé		Contact (sur clinicalTrials)
Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré - 92100 - Boulogne-Billancourt - France		Active, sans recrutement		Contact (sur clinicalTrials)
Réanimation Polyvalente - Centre Hospitalier Annecy Genevois - 74370 - Épagny - France	Noémie ZUCMAN	Recrutement non commencé		Contact (sur clinicalTrials)
Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne - 42270 - Saint-Priest-en-Jarez - France		Active, sans recrutement		Contact (sur clinicalTrials)
Réanimation Polyvalente - Hôpital Sainte Musse - 83056 - Toulon - France		Active, sans recrutement		Contact (sur clinicalTrials)
Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet - 49300 - Cholet - France		Active, sans recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT05696093 - Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial (COTRIVAP)

Informations générales
Etablissements
Critères
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