Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment … (NCT07512596) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
China48 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 formï¼›
* 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: ①fever (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: ①new 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 oxyg…
What they're measuring
1
The proportion of subjects who achieved clinical cure
Timeframe: Up to 28 days
2
The percentage difference in subjects achieving clinical cure between the experimental group and the control group
Timeframe: Up to 28 days
Trial details
NCT IDNCT07512596
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.