Nebulized and Intravenous Colistin in Ventilator Associated-pneumonia

• Status: Terminated
• Trial end date: 2018-06-19
• Target enrollment: 0
• Participant gender: All

Summary

Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Colistin

Criteria

Inclusion criteria

• Age older than 18 yr

• Invasive mechanical ventilation for more than 48 h Tracheostomized patients receiving intermittent mechanical ventilation can be included

• VAP caused by Gram-negative MDR bacteria resistant to all β-lactams and fluoroquinolones

Exclusion criteria

• Extrapulmonary Gram-negative MDR infection requiring intravenous colimycin

• VAP associated with bacteremia requiring combined treatment by nebulized and intravenous colimycin

• Hypersensitivity to colistimethate, colistin base, polymyxins and/or their excipients

• Porphyria

• Severe hypoxemia defined as PaO2 / FiO2< 100; if veno-venous ECMO is initiated, the patient can be included

• Severe brain injury (initial Glasgow coma score < 8) during the first 7 days before randomization

• Myasthenia

• cystic fibrosis

• Refusal to participate in the study

• Participation in any clinical study of a therapeutic investigational product within 30 days prior to the first day of inclusion

• No affiliation to social health insurance

• Patient under guardianship

• Pregnancy