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.
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;
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;
Parallel
TQD3524
DrugAfter entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects .
Meropenem for injection
DrugMeropenem for injection is a β-lactam.
Colistimethate Sodium for Injection
DrugColistimethate 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.
The proportion of subjects who achieved clinical cure
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.
The percentage difference in subjects achieving clinical cure between the experimental group and the control group
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.
The bacterial clearance rate
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.
The proportion of subjects who achieved clinical cure
The proportion of subjects in the mITT population who achieved clinical cure in the clinical efficacy evaluation at the EOT visit.
The proportion of subjects who achieved clinical cure
The proportion of subjects in the clinically evaluable (CE) population who achieved clinical cure in the clinical efficacy assessment at the EOT visit.
The proportion of subjects who achieved clinical cure
The proportion of subjects in the CE population who achieve clinical cure in the clinical efficacy evaluation during the TOC visit
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