Using cotrimoxazole to treat pneumonia in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Réanimation Médicale - Hôpital de la Pitié Salpêtrière
  Paris, France Recruiting
• Réanimation Médicale - Hôpital Européen Georges Pompidou
  Paris, France Recruiting
• Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
  Amiens, France Active not recruiting
• Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers
  Angers, France Active not recruiting
• Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry
  Béthune, France Active not recruiting
• Réanimation Médico-chirurgicale - Hôpital Avicenne
  Bobigny, France Not yet recruiting

Study contacts

• Study coordinator: Damien Roux, MD-PhD
• Email: damien.roux@aphp.fr
• Phone: 01.47.60.63.29

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.