• ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

  NCT07759934

  RecruitingInterventionalPhase 2Updated Aug 12, 2026
• Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.

  NCT07086391

  RecruitingObservationalUpdated Jul 25, 2025
• Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults

  NCT01940731

  Unknown statusInterventionalPhase 2Updated Sep 12, 2013
• A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection

  NCT06198764

  Unknown statusInterventionalPhase 3Updated Jan 10, 2024
• Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections

  NCT07089186

  RecruitingInterventionalPhase 3Updated Jul 30, 2025
• Inhaled Polymyxin E to Prevent VAP

  NCT06819462

  Not yet recruitingInterventionalNot ApplicableUpdated Feb 11, 2025

ClinicalTrials.gov ID

NCT07512596

Lead Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

48Estimated

Last Update Posted

Jul 17, 2026Actual

Start Date

Jul 2026Estimated

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

Official Title

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

Brief 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.

• Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia

• TQD3524
• Meropenem for injection
• Colistimethate Sodium for Injection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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;
• Individuals with allergic reactions to polymyxins or carbapenems;
• 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY

13673999263@163.com13673999263