Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria

Phase 2 Not yet recruiting 48 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria.

Timeline

Start: 2026-07
Primary completion: 2027-07
Completion: 2027-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Colistimethate	Unknown	2.5 mg/kg	Intravenous
Comparator	Colistimethate	Unknown	70 mg	Intravenous
Subject	TQD3524	Unknown	2.5 mg/kg	Intravenous
Subject	TQD3524	Unknown	3.75 mg/kg	Intravenous
Subject	TQD3524	Unknown	70 mg	Intravenous
Background	Meropenem	Small molecule	2 g	Intravenous

Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria

Summary

Timeline

Drugs

Indications