Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called cotrimoxazole as a treatment for ventilator-associated pneumonia (a type of lung infection that can occur in patients on mechanical ventilation) in adults in the intensive care unit (ICU). Researchers want to see if cotrimoxazole works as well as standard antibiotics for this condition. The trial is currently recruiting participants who are adults aged 65 and older, have been on a ventilator for at least five days, and have a confirmed diagnosis of this type of pneumonia.

To join the trial, participants need to have specific types of bacteria causing their infection that are known to respond well to cotrimoxazole. They should also have been treated with appropriate antibiotics for at least 24 hours and show signs of stability in their blood pressure and breathing. However, individuals who have certain health issues, allergies to the medication, or who are in a very critical state may not be eligible. Those who participate can expect to receive either cotrimoxazole or the standard antibiotics as part of their treatment, helping researchers learn more about the best ways to treat this serious infection.

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Eligibility 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