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

NCT06198764 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06198764 on ClinicalTrials.gov