Actively Recruiting
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-20
628
Participants Needed
30
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, with all bacteria susceptible to empiric therapy in polymicrobial cases
- Stability or improvement in hemodynamic (catecholamine dose) and respiratory (FIO2) parameters
You will not qualify if you...
- Hemodynamic instability with increasing catecholamine dose in the last 24 hours
- Contraindications to cotrimoxazole including allergy, advanced liver failure, severe renal dysfunction without hemodialysis, G6PD deficiency, hypersensitivity to sulphonamides, known macrocytic anemia, or methotrexate treatment
- Infections requiring prolonged antibiotic therapy such as pleural empyema, lung abscess, or necrotizing pneumonia
- Cystic fibrosis
- Immunosuppression including neutropenia, HIV with CD4 count below 200/mm3, immunosuppressive or corticosteroid therapy above 0.5 mg/kg/day before ICU admission
- Cardiac arrest without awakening
- Moribund state expected to die within 24 hours
- Limitation of life support with comfort care only at screening
- Participation in another interventional study on VAP care
- Pregnancy or breastfeeding
- Subject deprived of freedom or under legal protection
- No health insurance affiliation
- Refusal to participate by patient or legal representative
- Previous inclusion in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, France, 80054
Active, Not Recruiting
2
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers
Angers, France, 49100
Active, Not Recruiting
3
Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry
Béthune, France, 62660
Active, Not Recruiting
4
Réanimation Médico-chirurgicale - Hôpital Avicenne
Bobigny, France, 93000
Not Yet Recruiting
5
Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33000
Active, Not Recruiting
6
Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré
Boulogne-Billancourt, France, 92100
Active, Not Recruiting
7
Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet
Cholet, France, 49300
Active, Not Recruiting
8
Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied
Clermont-Ferrand, France, 63003
Active, Not Recruiting
9
Médecine Intensive Réanimation - Hôpital Louis Mourier
Colombes, France, 92700
Active, Not Recruiting
10
Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Active, Not Recruiting
11
Médecine Intensive Réanimation - Hôpital François Mitterrand
Dijon, France, 21079
Active, Not Recruiting
12
Réanimation Polyvalente - Centre Hospitalier Annecy Genevois
Épagny, France, 74370
Not Yet Recruiting
13
Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France, 85000
Active, Not Recruiting
14
Médecine Intensive Réanimation - Hôpital Michallon
La Tronche, France, 38700
Active, Not Recruiting
15
Réanimation Médicale - Hôpital Robert Salengro
Lille, France, 59037
Not Yet Recruiting
16
Réanimation médicale - Centre Hospitalier de Longjumeau
Longjumeau, France, 91160
Active, Not Recruiting
17
Réanimation et Surveillance continue - Centre Hospitalier de Melun
Melun, France, 77000
Active, Not Recruiting
18
Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois
Nancy, France, 54000
Active, Not Recruiting
19
Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec
Nantes, France, 44093
Not Yet Recruiting
20
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Active, Not Recruiting
21
Réanimation Médicale - Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
22
Réanimation Médicale - Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
23
Centre Hospitalier Intercommunal Saint-Germain-en-Laye
Poissy, France, 78003
Active, Not Recruiting
24
Médecine Intensive Réanimation - Hôpital René Dubos
Pontoise, France, 93500
Active, Not Recruiting
25
Médecine Intensive Réanimation - Centre Hospitalier Léon Binet
Provins, France, 77160
Not Yet Recruiting
26
Médecin Intensive Réanimation - Hôpital Delafontaine
Saint-Denis, France, 93200
Not Yet Recruiting
27
Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne
Saint-Priest-en-Jarez, France, 42270
Active, Not Recruiting
28
Médecine Intensive Réanimation - Nouvel Hôpital Civil
Strasbourg, France, 67091
Active, Not Recruiting
29
Réanimation Polyvalente - Hôpital Sainte Musse
Toulon, France, 83056
Active, Not Recruiting
30
Médecine Intensive Réanimation - Hôpital Bretonneau
Tours, France, 37000
Active, Not Recruiting
Research Team
D
Damien Roux, MD-PhD
CONTACT
A
Aline DECHANET
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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