About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- TQD3524
- Meropenem for injection
- Colistimethate Sodium for Injection