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RECRUITING

NCT05696093

PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Official title: Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

628

Start Date

2023-10-19

Completion Date

2026-12-31

Last Updated

2025-05-20

Healthy Volunteers

Conditions

Ventilator Associated Pneumonia

Interventions

DRUG

cotrimoxazole

Use of cotrimoxazole therapy for enterobacterial VAP

DRUG

standard antibiotic therapy

Use of standard antibiotic therapy for enterobacterial VAP

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

Locations (30)

Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie

Amiens, France

Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers

Angers, France

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

Réanimation Médicale - Hôpital de la Pitié Salpêtrière

Paris, France

Réanimation Médicale - Hôpital Européen Georges Pompidou

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

Médecine Intensive Réanimation - Nouvel Hôpital Civil

Strasbourg, France

Réanimation Polyvalente - Hôpital Sainte Musse

Toulon, France

Médecine Intensive Réanimation - Hôpital Bretonneau

Tours, France

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (30)