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COTRIVAP - Efficacy of cotrimoxazole as a de-escalation treatment of Ventilator-Associated Pneumonia in intensive care unit
EU CTIS ID: 2023-505108-52-00
What this study is testing
To demonstrate that cotrimoxazole is non-inferior to best standard of care for the treatment of VAP in ICU.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Adult (age ≥ 18 years)
- 2) Under mechanical ventilation for at least five days
- 3) Microbiologically confirmed VAP preferably on a distal lung sample (bronchoalveolar lavage or protected distal specimen) otherwise endotracheal aspiration
- 4) Enterobacteriaceae susceptible to cotrimoxazole, and for polymicrobial VAP, all bacteria susceptible to
- 5) Treated for at least 24 48 to 72 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
You likely can't join if
- 1) Known contra-indication to cotrimoxazole: o allergy, o advanced liver insufficiency, o renal dysfunction with clearance <15 mL/min/1.73 m² without hemodialysis o G6PD deficiency o history of hypersensitivity to one of the components (in particular, hypersensitivity to sulphonamides) o known macrocytic anaemia defined by VGM > 100 fl and haemoglobin < 11 g/dl o treatment with methotrexate
- 6) Moribund state (patient likely to die within 24h)
- 8) Enrolment to another interventional study on VAP care/management
- 9) Pregnancy or breastfeeding
- 10) Subject deprived of freedom, subject under a legal protective measure
- 11) No affiliation to any health insurance system
See the full eligibility criteria
- 1) Adult (age ≥ 18 years)
- 2) Under mechanical ventilation for at least five days
- 3) Microbiologically confirmed VAP preferably on a distal lung sample (bronchoalveolar lavage or protected distal specimen) otherwise endotracheal aspiration
- 4) Enterobacteriaceae susceptible to cotrimoxazole, and for polymicrobial VAP, all bacteria susceptible to
- 5) Treated for at least 24 48 to 72 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
- 1) Known contra-indication to cotrimoxazole: o allergy, o advanced liver insufficiency, o renal dysfunction with clearance <15 mL/min/1.73 m² without hemodialysis o G6PD deficiency o history of hypersensitivity to one of the components (in particular, hypersensitivity to sulphonamides) o known macrocytic anaemia defined by VGM > 100 fl and haemoglobin < 11 g/dl o treatment with methotrexate
- 6) Moribund state (patient likely to die within 24h)
- 8) Enrolment to another interventional study on VAP care/management
- 9) Pregnancy or breastfeeding
- 10) Subject deprived of freedom, subject under a legal protective measure
- 11) No affiliation to any health insurance system
- 12) Refusal to participate to the study (patient or legal representative or family member or close relative if present)
- 13) Patients previously included in the study
- 2) Infection requiring prolonged antibiotic-therapy (pleural empyema, lung abscess, necrotizing pneumonia, etc…)
- 3) Cystic fibrosis
- 4) Immunosuppression (neutropenia, HIV with CD4 lymphocytes below 200/mm3, immunosuppressive therapy or corticosteroid therapy >0.5 mg/kg/j before ICU admission)
- 5) Cardiac arrest without awakening
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.