A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin … (NCT06966284) | Clinical Trial Compass
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A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection
Taiwan480 participantsStarted 2025-11-26
Plain-language summary
This is a retrospective, observational, post-marketing study to evaluate the clinical response, microbiological response, mortality, and safety of intravenous polymyxin B and colistin methanesulfonate in patients with carbapenem-resistant gram-negative bacterial infection. Subgroup analysis by sites of infection, infectious pathogens, and baseline renal function will also be performed.
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
. Patient ≥ 18 years of age.
. Patient diagnosed with bacterial pneumonia and/or bacteremia, or other physician judged serious infection (except urinary tract infection, UTI) caused by Carbapenem-Resistant Gram-Negative Bacteria (CR-GNB).
. Patient received intravenous polymyxin B or CMS treatment for ≥72 h.
. Administration of polymyxin B or CMS within 7 days from the infection onset day.
Exclusion criteria
. Patient with bacteremia caused by urinary tract infection.
. CR-GNB known to be resistant to polymyxin B or CMS.
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
1
Clinical response rate of polymyxin B and CMS treatment groups at TOC
Timeframe: TOC: End of Treatment + 7 days
2
Microbiological response rate of polymyxin B and CMS treatment groups at TOC
Timeframe: TOC: End of Treatment + 7 days
3
All-cause mortality of of polymyxin B and CMS treatment groups at Day 28
Timeframe: Day 28 from start of treatment
4
Clinical response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Timeframe: End of Treatment + 7 days
5
Microbiological response rate of polymyxin B group by sites of infection and infectious pathogens at TOC
Timeframe: End of Treatment + 7 days
6
Infection-related mortality of two treatment groups at Day 28
. Patient has infectious disease (s) caused by the following gram-negative bacteria which are known to have no response to polymyxin B and/or colistin treatment: Proteus spp., Providencia spp., Morganella spp., Serratia marcescens, Burkholderia spp., and Neisseria spp.
. Intravenous administration of polymyxin B or colistin more than 28 days.
. Both the treatment efficacy and safety could not be evaluated.