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

April 1, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The First Affiliated Hospital Of Bengbu Medical College
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102200
        • Beijing Tsinghua Changgung Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China, 528200
        • Foshan Nanhai District People's Hospital
        • Contact:
          • Zongmian Zhang, Bachelor
          • Phone Number: 13590550630
          • Email: mian74@qq.com
      • Guangzhou, Guangdong, China, 510120
        • The First Clinical College of Guangzhou Medical University
        • Contact:
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
        • Contact:
        • Contact:
      • Zhuhai, Guangdong, China, 519000
        • The Fifth Affiliated Hospital, Sun Yat-sen University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan provincial people's hospital
        • Contact:
      • Zhengzhou, Henan, China, 450007
        • Zhengzhou Central Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • The Fifth Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410005
        • People's Hospital of Hunan Province
        • Contact:
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225000
        • Northern Jiangsu People's Hospital
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
      • Xi'an, Shaanxi, China, 710100
        • Xi'an Chest Hospital
      • Xianyang, Shaanxi, China, 712000
        • Yan'an University Xianyang Hospital
        • Contact:
          • Jianhou Jia, Master
          • Phone Number: 13892007197
          • Email: jjh20@126.com
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Pulmonary Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610031
        • Chengdu Third People's Hospital
        • Contact:
          • Guoping Li, Doctor
          • Phone Number: 18982791605
          • Email: lzlgp@163.com
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610051
        • Nuclear Industry 416 Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital
        • Contact:
      • Tianjin, Tianjin Municipality, China, 300191
        • Tianjin First Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years old (based on the date of signing the informed consent form);
  • The subject (or their guardian) voluntarily signed the informed consent form；
  • Acute pulmonary infection with hospitalization duration exceeding 48 hours or within 7 days after discharge; or acute pulmonary infection patients who have undergone mechanical ventilation via oral or nasal tracheal intubation for at least 48 hours;
  • Chest imaging examination (X-ray or CT) within 72 hours prior to randomization reveals characteristics of new or worsening pulmonary infiltration;
  • At least one of the following physical signs or laboratory abnormalities: ① fever (temperature ≥38℃); ② hypothermia (temperature ≤35℃); ③ elevated peripheral white blood cell count (WBC ≥10×10^9/L); ④ decreased white blood cell count (WBC ≤4.5×10^9/L); ⑤ more than 15% of immature neutrophils such as band forms in peripheral blood;
  • At least one of the following clinical symptoms is present: ① new or acute worsening of pulmonary symptoms or signs, such as cough, dyspnea, increased respiratory rate (respiratory rate > 25 breaths per minute), expectoration, or the need for mechanical ventilation; ② hypoxemia (arterial blood gas oxygen partial pressure below 60 mmHg at standard atmospheric pressure, or a progressive decrease in the ratio of oxygen partial pressure to inspired oxygen concentration (PaO2/FiO2)); ③ deteriorating oxygenation requiring replacement of ventilation support system to improve oxygenation, or a change in the level of positive end-expiratory pressure support; ④ new respiratory secretions requiring suction;
  • A specific carbapenem-resistant Gram-negative bacterium was cultured from qualified lower respiratory tract specimens within the first five days/screening period, with in vitro susceptibility testing confirming resistance to carbapenems；
  • Female subjects without reproductive potential must meet at least one of the following criteria: a) cessation of regular menstruation for at least 12 consecutive months; b) having undergone hysterectomy and/or bilateral oophorectomy. Female subjects with reproductive potential must have a negative serum pregnancy test result at the screening visit and agree to use reliable contraception throughout the study period;
  • Male subjects must agree to adopt reliable contraceptive measures throughout the entire study period.

Exclusion Criteria:

  • Those who currently suffer from epilepsy/myasthenia gravis or have a history of seizures (excluding febrile seizures in childhood)/myasthenia gravis;
  • Those who are undergoing hemodialysis or peritoneal dialysis;
  • Combined infections with other lung microbiota: viral pneumonia, fungal pneumonia, pulmonary tuberculosis, atypical pathogen infections, etc；
  • Current concurrent infection of other parts/organs;
  • Patients with concurrent refractory septic shock, who still exhibit persistent hypotension despite adequate fluid resuscitation or vasopressor therapy prior to randomization;
  • Individuals with immune deficiency or compromised immune function, including but not limited to: human immunodeficiency virus infection, hematological malignancies, bone marrow transplantation, immunosuppressive therapy, and systemic corticosteroid treatment (defined as a daily dose equivalent to prednisone ≥20mg and a treatment duration >14 days);
  • During the screening period, any of the following laboratory abnormalities is present: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels are more than 5 times the upper limit of normal, or AST and/or ALT levels are more than 3 times the upper limit of normal and total bilirubin levels are more than 1.5 times the upper limit of normal, or neutrophil count < 1.0×10^9/L, or platelet count < 60×10^9/L; creatinine clearance rate (cLcr) ≤ 50 mL/min;
  • Suffering from lung diseases that can interfere with treatment response assessment;
  • Patients with lung abscess, empyema, and mechanical obstructive pneumonia;
  • New York Heart Association (NYHA) class III-IV heart failure;
  • Transplant patients；
  • Patients with an estimated survival time of less than 1 month according to the clinical judgment of the researchers;
  • Those who have allergic reactions to polymyxins or any β-lactams (such as carbapenems, penicillins, monocyclic lactams, cephalosporins);
  • Sbjects requiring >2 systemic antimicrobial drugs for the treatment of Gram-negative bacterial infections;
  • Patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 30;
  • Women who are pregnant or breastfeeding;
  • Use potentially effective antibiotics to treat carbapenem resistant gram-negative bacterial infections within 72 hours prior to randomization, and the treatment duration exceeds 24 hours；
  • When the culture results of samples from the first 5 days/screening period are available, it is found that the subject has Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia (HAP/VAP) caused by gram-negative bacteria that are expected to have no response to polymyxin drugs;
  • Subjects who have participated in other clinical trials within 30 days prior to the first dose of medication;
  • Other factors determined by the researcher that make the subject unsuitable for participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose TQD3524 + Meropenem for injection
TQD3524: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: TQD3524
After entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects .
Drug: Meropenem for injection
Meropenem for injection is a β-lactam.
Active Comparator: Colistimethate Sodium for Injection + Meropenem for injection (Low-dose control)
Colistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: Meropenem for injection
Meropenem for injection is a β-lactam.
Drug: Colistimethate 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.
Experimental: High-dose TQD3524 + Meropenem for injection
TQD3524: 3.75mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: TQD3524
After entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects .
Drug: Meropenem for injection
Meropenem for injection is a β-lactam.
Active Comparator: Colistimethate Sodium for Injection + Meropenem for injection (High-dose control)
Colistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: Meropenem for injection
Meropenem for injection is a β-lactam.
Drug: Colistimethate 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects who achieved clinical cure
Time Frame: Up to 28 days
The proportion of subjects who achieved clinical cure in the modified intention-to-treat (mITT) population at the treatment-end visit (TOC) based on clinical efficacy evaluation.
Up to 28 days
The percentage difference in subjects achieving clinical cure between the experimental group and the control group
Time Frame: Up to 28 days
During the TOC visit, the percentage difference in subjects achieving clinical cure between the modified intention-to-treat (mITT) populations of the test group and the control group.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The bacterial clearance rate
Time Frame: Up to 28 days
The bacterial clearance rate at the Time of Clinical Outcome (TOC) visit and the End of Treatment (EOT) visit in the microbiologically Improved Intent-to-Treat (micro-mITT) population and the Microbiologically Evaluable (ME) population.
Up to 28 days
The proportion of subjects who achieved clinical cure
Time Frame: Up to 21 days
The proportion of subjects in the mITT population who achieved clinical cure in the clinical efficacy evaluation at the EOT visit.
Up to 21 days
The proportion of subjects who achieved clinical cure
Time Frame: Up to 21 days
The proportion of subjects in the clinically evaluable (CE) population who achieved clinical cure in the clinical efficacy assessment at the EOT visit.
Up to 21 days
The proportion of subjects who achieved clinical cure
Time Frame: Up to 28 days
The proportion of subjects in the CE population who achieve clinical cure in the clinical efficacy evaluation during the TOC visit
Up to 28 days
All-cause mortality
Time Frame: Up to 28 days
All-cause mortality rate in the mITT population on Day 28 ± 2 after the first dose.
Up to 28 days
Average duration of mechanical ventilation
Time Frame: Up to 28 days
The average duration of mechanical ventilation in the mITT population.
Up to 28 days
Average length of hospital stay
Time Frame: Up to 28 days
The average length of hospital stay from the first dose to the end of the follow-up period in the mITT population.
Up to 28 days
Change in APACHE II score
Time Frame: Up to 28 days
Changes in APACHE II scores before and after treatment in the mITT population. The higher the score, the more severe the condition.
Up to 28 days
Change value of procalcitonin
Time Frame: Up to 28 days
Change in procalcitonin levels from baseline during TOC visits in the mITT population.
Up to 28 days
The proportion of patients experiencing adverse reactions
Time Frame: Up to 28 days
The proportion of patients experiencing adverse reactions.
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQD3524-II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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