Actively Recruiting
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit Multicentric Non-inferiority Randomised Controlled Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-20
628
Participants Needed
30
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of cotrimoxazole compared to standard antibiotic therapy for treating ventilator-associated pneumonia (VAP) caused by Enterobacteriaceae in adult patients in intensive care units (ICU). This multicenter randomized trial aims to determine if cotrimoxazole is not inferior to the best standard care in terms of survival 28 days after treatment begins. Patients with confirmed VAP and susceptibility to cotrimoxazole are included, with specific attention to those with or without septic shock and COVID-19 pneumonia. Participants are randomly assigned to receive either cotrimoxazole or standard antibiotic treatment, such as beta-lactams or fluoroquinolones, for a total of 7 days including initial empiric treatment. The antibiotic dosing and administration are adjusted based on current ICU recommendations. The treatment period can last up to 28 days or until death or ICU discharge if earlier. The study is not blinded due to variable therapies in the control group. During the study, patients are monitored daily until death, ICU discharge, or day 28 for vital signs, antibiotic use, new infections, and Clostridium difficile infection. Clinical and radiological evaluations occur at day 7, and weekly screening for multidrug-resistant bacteria is performed. Survival status is followed up to 90 days through phone or hospital interview. An independent committee reviews clinical and radiological outcomes without knowledge of treatment assignment to ensure unbiased assessment.
CONDITIONS
Brief 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
- On mechanical ventilation for at least five days
- Microbiologically confirmed ventilator-associated pneumonia with a lung sample
- Infection caused by Enterobacteriaceae susceptible to cotrimoxazole
- Treated for at least 24 hours with appropriate empiric antibiotic therapy
- Stable blood pressure and respiratory parameters (no recent increase in support medications)
You will not qualify if you...
- Haemodynamic instability with increasing catecholamine dose in the last 24 hours
- Allergy or contraindications to cotrimoxazole including liver failure, severe kidney dysfunction without dialysis, G6PD deficiency, or hypersensitivity to sulphonamides
- Known macrocytic anemia or treatment with methotrexate
- Infection requiring prolonged antibiotic therapy (e.g., empyema, lung abscess)
- Cystic fibrosis
- Immunosuppression such as neutropenia, low CD4 count in HIV, or immunosuppressive therapy
- Cardiac arrest without awakening
- Moribund state likely to die within 24 hours
- Limitation of life support measures at screening
- Participation in another interventional VAP study
- Pregnancy or breastfeeding
- Legal restrictions on freedom or protective measures
- No health insurance affiliation
- Refusal to participate by patient or representative
- Previous inclusion in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 28 days or until ICU discharge or death
Participants receive either cotrimoxazole or standard antibiotic therapy for ventilator-associated pneumonia in the ICU.
Daily visits during ICU stay up to 28 days
Duration - Up to 90 days after treatment start
Participants are monitored after treatment for vital status and clinical outcomes up to 90 days after inclusion.
Follow-up phone or hospital visits as applicable
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
A
Aline DECHANET
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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