Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection

Recruiting 404 enrolled Southeast University, China

RandomizedParallel-groupOpen-labelTreatment

Summary

Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.

Timeline

Start: 2023-11-27
Primary completion: 2025-12-31
Completion: 2025-12-31

Publications

Li X, Zhang C, Li J, Chen T, Xie J, Huang Y. Multicentre open-label randomised controlled trial comparing the efficacy and safety of colistin-based combination therapy with the best available therapy for treating hospital-acquired pneumonia or bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (COUNT-CRE): a study protocol. BMJ Open. 2025 Jul 16;15(7):e092157. doi: 10.1136/bmjopen-2024-092157.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colistin	Other / unclassified	300 mg	Intravenous
Subject	Colistin	Other / unclassified	360 mg	Intravenous
Background	Amikacin	Small molecule	0.8 g	—
Background	Ceftazidime-avibactam	Other / unclassified	2.5 g	—
Background	IMIPENEM ANHYDROUS	Small molecule	1 g	—
Background	Meropenem	Small molecule	1 g	—
Background	Meropenem	Small molecule	2 g	—
Background	Tigecycline	Small molecule	100 mg	—
Background	metroperan	Unknown	—	—

Indications

No indication recorded.