Actively Recruiting
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
Led by TTY Biopharm · Updated on 2026-03-09
480
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 and/or bacteremia, or other serious infection caused by carbapenem-resistant gram-negative bacteria
- Carbapenem-resistant gram-negative bacteria defined as resistant to at least one carbapenem antibiotic or producing carbapenemase
- Diagnosed hospital-acquired or ventilator-associated bacterial pneumonia meeting clinical and imaging criteria
- Diagnosed bloodstream infection or sepsis caused by carbapenem-resistant gram-negative bacteria, excluding urinary tract infection
- Received intravenous polymyxin B or colistin methanesulfonate treatment for at least 72 hours
- Treatment started within 7 days from the infection onset date (specimen collection date)
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 gram-negative bacteria not responsive to polymyxin B or colistin, including Proteus spp., Providencia spp., Morganella spp., Serratia marcescens, Burkholderia spp., and Neisseria spp.
- Intravenous polymyxin B or colistin treatment longer than 28 days
- Inability to evaluate treatment efficacy and safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
A
Angel Chen
CONTACT
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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