[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hospital-acquired-bacterial-pneumoniaventilator-associated-bacterial-pneumonia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hospital-acquired-bacterial-pneumoniaventilator-associated-bacterial-pneumonia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100632354","phase-2-study-on-the-safety-and-efficacy-of-polymyxin-e2-methanesulfonate-for-injection-in-the-treatment-of-hospital-acquired-bacterial-pneumoniaventilator-associated-bacterial-pneumonia-caused-by-carbapenem-resistant-gram-negative-bacteria-100632354",false,"NCT07512596","Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia\u002FVentilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria","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\u002FVentilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Gram-negative Bacteria","Inclusion Criteria:\n\n* Age ≥ 18 years old (based on the date of signing the informed consent form);\n* The subject (or their guardian) voluntarily signed the informed consent form；\n* 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;\n* Chest imaging examination (X-ray or CT) within 72 hours prior to randomization reveals characteristics of new or worsening pulmonary infiltration;\n* 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\u002FL); ④ decreased white blood cell count (WBC ≤4.5×10\\^9\u002FL); ⑤ more than 15% of immature neutrophils such as band forms in peripheral blood;\n* 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\u002FFiO2)); 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;\n* A specific carbapenem-resistant Gram-negative bacterium was cultured from qualified lower respiratory tract specimens within the first five days\u002Fscreening period, with in vitro susceptibility testing confirming resistance to carbapenems；\n* 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\u002For 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;\n* Male subjects must agree to adopt reliable contraceptive measures throughout the entire study period.\n\nExclusion Criteria:\n\n* Those who currently suffer from epilepsy\u002Fmyasthenia gravis or have a history of seizures (excluding febrile seizures in childhood)\u002Fmyasthenia gravis;\n* Those who are undergoing hemodialysis or peritoneal dialysis;\n* Combined infections with other lung microbiota: viral pneumonia, fungal pneumonia, pulmonary tuberculosis, atypical pathogen infections, etc；\n* Current concurrent infection of other parts\u002Forgans;\n* Patients with concurrent refractory septic shock, who still exhibit persistent hypotension despite adequate fluid resuscitation or vasopressor therapy prior to randomization;\n* 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);\n* During the screening period, any of the following laboratory abnormalities is present: aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) levels are more than 5 times the upper limit of normal, or AST and\u002For 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 \\\u003C 1.0×10\\^9\u002FL, or platelet count \\\u003C 60×10\\^9\u002FL; creatinine clearance rate (cLcr) ≤ 50 mL\u002Fmin;\n* Suffering from lung diseases that can interfere with treatment response assessment;\n* Patients with lung abscess, empyema, and mechanical obstructive pneumonia;\n* New York Heart Association (NYHA) class III-IV heart failure;\n* Transplant patients；\n* Patients with an estimated survival time of less than 1 month according to the clinical judgment of the researchers;\n* Those who have allergic reactions to polymyxins or any β-lactams (such as carbapenems, penicillins, monocyclic lactams, cephalosporins);\n* Sbjects requiring \\>2 systemic antimicrobial drugs for the treatment of Gram-negative bacterial infections;\n* Patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 30;\n* Women who are pregnant or breastfeeding;\n* 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；\n* When the culture results of samples from the first 5 days\u002Fscreening period are available, it is found that the subject has Hospital-Acquired Pneumonia\u002FVentilator-Associated Pneumonia (HAP\u002FVAP) caused by gram-negative bacteria that are expected to have no response to polymyxin drugs;\n* Subjects who have participated in other clinical trials within 30 days prior to the first dose of medication;\n* Other factors determined by the researcher that make the subject unsuitable for participating in this study.","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia\u002FVentilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria.",[26],"Hospital-acquired Bacterial Pneumonia\u002FVentilator-associated Bacterial Pneumonia","NOT_YET_RECRUITING","2026-04-01",{"date":30,"type":31},"2026-04-06","ACTUAL",{"date":33,"type":20},"2026-04",{"date":35,"type":20},"2027-07",{"name":37,"class":38},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",26]