Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-02.
Status change: Not Yet Recruiting → Recruiting 2026-03-05
Trial Details
NCT Number NCT06966284
Lead Sponsor TTY Biopharm
Conditions Bacteremia Caused by Gram-Negative Bacteria, Bacterial Pneumonia
Enrollment 480 participants
Start Date 2025-11-26
Primary Completion 2028-11-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-09