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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Treatment groups

48 Participants
are divided into 4 treatment groups