Home › Trials › NCT05696093

Using cotrimoxazole to treat pneumonia in ICU patients

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

PHASE3 · Assistance Publique - Hôpitaux de Paris · NCT05696093

This study is testing if cotrimoxazole can effectively treat pneumonia in ICU patients on ventilators, compared to standard antibiotics, to see if it helps them recover better.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment628 (estimated)
Ages18 Years and up
SexAll
SponsorAssistance Publique - Hôpitaux de Paris (other)
Drugs / interventionsmethotrexate
Locations30 sites (Amiens and 29 other locations)
Trial IDNCT05696093 on ClinicalTrials.gov

What this trial studies

This multicentre randomized non-inferiority trial evaluates the efficacy of cotrimoxazole as a de-escalation treatment for adult patients with ventilator-associated pneumonia (VAP) in intensive care units. Patients with microbiologically confirmed VAP due to Enterobacteriaceae susceptible to cotrimoxazole will be randomly assigned to receive either cotrimoxazole or standard antibiotic therapy for a total of 7 days. The study aims to optimize antibiotic administration based on the latest recommendations and will involve daily follow-ups until patient discharge or death. The trial will assess clinical outcomes, including vital status and potential new infections.

Who should consider this trial

Good fit: Ideal candidates are adult ICU patients on mechanical ventilation for at least five days with microbiologically confirmed VAP due to susceptible Enterobacteriaceae.

Not a fit: Patients with hemodynamic instability or contraindications to cotrimoxazole will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and targeted approach to managing ventilator-associated pneumonia in ICU patients.

How similar studies have performed: Other studies have explored antibiotic de-escalation strategies, but the specific use of cotrimoxazole in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Amiens and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ventilator Associated Pneumonia, intensive care unit, de-escalation, cotrimoxazole

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.