NCT06966284

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

A Retrospective, Observational, Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Infusions Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 480 (estimated)
• Sponsor: TTY Biopharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacteremia Caused by Gram-Negative Bacteria
• Bacterial Pneumonia

Timeline

• Start date: 2025-11-26
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2025-05-11
• Last updated: 2026-03-09

Locations

1 site across 1 country: Taiwan