TerminatedPhase 3

Nebulized and Intravenous Colistin in Ventilator Associated-pneumonia

Stopped: Lack of inclusion

France7 participantsStarted 2017-07-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical cure of VAP caused by Gram-negative multidrug resistant bacteria

Timeframe: At end of therapy visit (day11) or before day11 if treatment is considered as failed.

Trial details

NCT IDNCT02906722

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-27

View on ClinicalTrials.gov More Ventilator-associated Pneumonia trials