NCT06198764

A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection

A Multicenter, Randomized, Open, Parallel Controlled Clinical Study to Evaluate the Efficacy and Safety of Colistimethate Sodium for Injection in the Treatment of Carbapenem Resistant Gram-negative Infections in Chinese Adults.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A clinical study to evaluate Colistimethate Sodium for Injection combination with Meropenem versus Coly-Mycin® M Parenteral combined with Meropenem in the treatment of Carbapenem resistant gram-negative bacteria infection. A total of 80 patients will be enrolled in the study.

Conditions

• Mental Health Issue

Interventions

Type	Name	Description
DRUG	Colistimethate sodium for injection	Colistimethate Sodium for Injection is the Prodrug of Polymyxin E, which is hydrolyzed into Polymyxin E after entering the human body to play a bactericidal role.Polymyxin selectively acts on gram-negative aerobic bacteria with hydrophobic outer membrane, leading to cell death by destroying the cell membrane.
DRUG	Meropenem for Injection	Meropenem is a broad-spectrum carbapenem antibiotic that inhibits the synthesis of bacterial cell walls by penetrating the cell wall and reaching its target, the penicillin-binding protein, to ultimately produce antibacterial effects.
DRUG	Coly Mycin M Injectable Product	Coly Mycin M is the originally marketed colistimethate sodium for injection.

Timeline

• Start date: 2023-07-06
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-01-10
• Last updated: 2024-01-10

Locations

32 sites across 1 country: China