RecruitingPhase 2NCT07512596

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

Randomized, Double-blind, Parallel-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Polymyxin E2 Mesylate Intravenous Infusion Combined With Nebulized Inhalation in the Treatment of Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Gram-negative Bacteria


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

48 participants

Start Date

Jul 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Colistimethate Sodium for Injection, a drug called Meropenem for injection, and others for people with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. The study is currently recruiting participants at 27 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQD3524

After entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects .

DRUGMeropenem for injection

Meropenem for injection is a β-lactam.

DRUGColistimethate Sodium for Injection

Colistimethate Sodium for Injection is a prodrug of polymyxin E. After entering the body, polymyxin E mesylate is hydrolyzed to polymyxin E (colistin), which exerts bactericidal activity.


Locations(27)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Foshan Nanhai District People's Hospital

Foshan, Guangdong, China

The First Clinical College of Guangzhou Medical University

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, Guangdong, China

The Second Hospital Of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Zhengzhou Central Hospital

Zhengzhou, Henan, China

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

People's Hospital of Hunan Province

Changsha, Hunan, China

The Third Hospital of Changsha

Changsha, Hunan, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Xi'an Chest Hospital

Xi'an, Shaanxi, China

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Chengdu Third People's Hospital

Chengdu, Sichuan, China

Nuclear Industry 416 Hospital

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07512596