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.

NCT06198764 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	80
Start date	2023-07-06
Completion	2026-03

Conditions

• Mental Health Issue

Interventions

• Colistimethate sodium for injection
• Meropenem for Injection
• Coly Mycin M Injectable Product

Primary outcomes

• Clinical cure rate (mITT) — At TOC visit, which is 7-14 days after the end of treatment.
  The proportion of patients in the modified intention to treat (mITT) population who achieved clinical cure at test of cure (TOC).

Countries

China