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Tests treatment safety and results for Ventilator Associated Pneumonia
Official title Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
ClinicalTrials.gov ID: NCT05696093
What this study is testing
What is cotrimoxazole?
cotrimoxazole is an investigational medicine, given as an once-weekly, being studied as a potential treatment for ventilator associated pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- Stability of haemodynamic (stability or decrease in catecholamine dose) and respiratory (stability or improvement of FIO2) parameters
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Béthune, France
- Bobigny, France
- Bordeaux, France
- Boulogne-Billancourt, France
- Cholet, France
- Clermont-Ferrand, France
- Colombes, France
- Corbeil-Essonnes, France
- Dijon, France
- Épagny, France
- La Roche-sur-Yon, France
- La Tronche, France
- Lille, France
- Longjumeau, France
- Melun, France
- Nancy, France
- Nantes, France
- Paris, France
+ 8 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Béthune, France; Bobigny, France; Bordeaux, France; Boulogne-Billancourt, France and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.