Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
ACTIVE_NOT_RECRUITING
Amiens
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers
ACTIVE_NOT_RECRUITING
Angers
Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry
ACTIVE_NOT_RECRUITING
Béthune
Réanimation Médico-chirurgicale - Hôpital Avicenne
NOT_YET_RECRUITING
Bobigny
Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin
ACTIVE_NOT_RECRUITING
Bordeaux
Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré
ACTIVE_NOT_RECRUITING
Boulogne-billancourt
Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet
ACTIVE_NOT_RECRUITING
Cholet
Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied
ACTIVE_NOT_RECRUITING
Clermont-ferrand
Médecine Intensive Réanimation - Hôpital Louis Mourier
ACTIVE_NOT_RECRUITING
Colombes
Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien
ACTIVE_NOT_RECRUITING
Corbeil-essonnes
Médecine Intensive Réanimation - Hôpital François Mitterrand
ACTIVE_NOT_RECRUITING
Dijon
Réanimation Polyvalente - Centre Hospitalier Annecy Genevois
NOT_YET_RECRUITING
Épagny
Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée
ACTIVE_NOT_RECRUITING
La Roche-sur-yon
Médecine Intensive Réanimation - Hôpital Michallon
ACTIVE_NOT_RECRUITING
La Tronche
Réanimation Médicale - Hôpital Robert Salengro
NOT_YET_RECRUITING
Lille
Réanimation médicale - Centre Hospitalier de Longjumeau
ACTIVE_NOT_RECRUITING
Longjumeau
Réanimation et Surveillance continue - Centre Hospitalier de Melun
ACTIVE_NOT_RECRUITING
Melun
Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois
ACTIVE_NOT_RECRUITING
Nancy
Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec
NOT_YET_RECRUITING
Nantes
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
ACTIVE_NOT_RECRUITING
Paris
Réanimation Médicale - Hôpital de la Pitié Salpêtrière
RECRUITING
Paris
Réanimation Médicale - Hôpital Européen Georges Pompidou
RECRUITING
Paris
Centre Hospitalier Intercommunal Saint-Germain-en-Laye
ACTIVE_NOT_RECRUITING
Poissy
Médecine Intensive Réanimation - Hôpital René Dubos
ACTIVE_NOT_RECRUITING
Pontoise
Médecine Intensive Réanimation - Centre Hospitalier Léon Binet
NOT_YET_RECRUITING
Provins
Médecin Intensive Réanimation - Hôpital Delafontaine
NOT_YET_RECRUITING
Saint-denis
Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne
ACTIVE_NOT_RECRUITING
Saint-priest-en-jarez
Médecine Intensive Réanimation - Nouvel Hôpital Civil
ACTIVE_NOT_RECRUITING
Strasbourg
Réanimation Polyvalente - Hôpital Sainte Musse
ACTIVE_NOT_RECRUITING
Toulon
Médecine Intensive Réanimation - Hôpital Bretonneau
ACTIVE_NOT_RECRUITING
Tours
Contact Information
Primary
Damien Roux, MD-PhD
damien.roux@aphp.fr
01.47.60.63.29
Backup
Aline DECHANET
aline.dechanet@aphp.fr
01.40.25.78.30
Time Frame
Start Date: 2023-10-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 628
Treatments
Experimental: cotrimoxazole
Use of cotrimoxazole for enterobacterial VAP. Posology and modalities of antibiotic administration will be optimized based on most recent recommendations for ICU patient. They will receive the treatment for 28 days or until death or until ICU discharge if its before 28days.
Active_comparator: standard antibiotic therapy
Use of standard antibiotic therapy enterobacterial VAP. Posology and modalities of antibiotic administration will be optimized based on most recent recommendations for ICU patient. They will receive the treatment for 28 days or until death or until ICU discharge if its before 28days.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris