Nebulized and Intravenous Colistin in Ventilator Associated-pneumonia (NCT02906722) | Clinical Trial Compass
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.
1This trial was terminated before it finished — do you know why it was stopped early, and does that affect how much we can trust the safety and effectiveness data that was collected?
2Since this study was testing both nebulized and intravenous colistin together for ventilator-associated pneumonia caused by multidrug-resistant bacteria, is combining these two delivery methods something you would still consider for my situation, or has other evidence since changed that approach?
3Colistin is known to have serious side effects like kidney toxicity — given that this trial was Phase 3 and was terminated, what do we actually know about how safe this combination was for the patients who did participate?
4Are there currently approved or better-studied treatment options for multidrug-resistant gram-negative ventilator-associated pneumonia that my care team would recommend over an approach based on an incomplete trial like this one?
5If I am on a ventilator and develop a resistant bacterial pneumonia, how would my doctors decide between standard antibiotic regimens and something like the nebulized-plus-IV colistin approach that this trial was investigating?
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
1
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.