Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05696093

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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