Actively Recruiting
A Retrospective, Observational, 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
Led by TTY Biopharm · Updated on 2026-03-09
480
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical and microbiological responses, mortality rates, and safety of intravenous polymyxin B and colistin methanesulfonate (CMS) treatments in patients with carbapenem-resistant gram-negative bacterial infections. This retrospective, observational post-marketing study includes subgroup analyses based on infection sites, pathogens involved, and patients' baseline kidney function to better understand treatment effects. The study observes patients who have received either polymyxin B or CMS intravenously for at least 72 hours within seven days of infection onset. It compares clinical and microbiological response rates at the end of treatment plus seven days and tracks mortality at 14 and 28 days from treatment start. The study examines these outcomes across different infection sites, pathogens, and kidney function levels. Participants' medical records will be reviewed to assess treatment responses, mortality, and safety outcomes. Researchers will analyze clinical and microbiological data at various time points, including Day 7, Day 14, Day 28, end of treatment, and follow-up. The primary measures include clinical response rates, microbiological response rates, and mortality rates related to infection and all causes. The study does not involve new treatments but collects data retrospectively from past intravenous polymyxin B or CMS use.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years of age or older
- Diagnosed with bacterial pneumonia, bacteremia, or serious infection caused by carbapenem-resistant gram-negative bacteria (CR-GNB)
- Received intravenous polymyxin B or colistin methanesulfonate treatment for at least 72 hours
- Treatment started within 7 days from the infection onset day
- For pneumonia, must meet clinical criteria for hospital-acquired or ventilator-associated bacterial pneumonia
- For bacteremia/sepsis, documented bloodstream infection caused by carbapenem-resistant gram-negative pathogen or systemic infection meeting clinical criteria
You will not qualify if you...
- Bacteremia caused by urinary tract infection
- Carbapenem-resistant gram-negative bacteria known to be resistant to polymyxin B or colistin methanesulfonate
- Infectious diseases caused by Proteus spp., Providencia spp., Morganella spp., Serratia marcescens, Burkholderia spp., or Neisseria spp.
- Intravenous treatment with polymyxin B or colistin for more than 28 days
- Inability to evaluate treatment efficacy and safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 72 hours, up to 28 days
Participants receive intravenous polymyxin B or colistin methanesulfonate treatment for their carbapenem-resistant gram-negative bacterial infection.
Visits aligned with treatment duration to monitor clinical and microbiological response
Duration - Up to 28 days from start of treatment
Participants are monitored for clinical response, microbiological response, and mortality outcomes up to 28 days after the start of treatment.
Visits on Day 7, Day 14, Day 28, End of Treatment, and Test of Cure (End of Treatment + 7 days)
Trial Site Locations
Total: 1 location
1
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
A
Angel Chen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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