[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632354":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":43,"locations":49,"responsibleParty":411,"collaborators":34,"id":413,"slug":414,"hasResults":415,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":34,"eligibilityCriteria":419,"healthyVolunteers":415,"sex":420,"minAge":421,"maxAge":34,"enrollmentInfo":422,"targetDuration":34,"studyType":425,"phases":426,"briefSummary":428,"conditions":429,"keywords":34,"overallStatus":431,"whyStopped":34,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":441},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-dose TQD3524 + Meropenem for injection","EXPERIMENTAL","TQD3524: 2.5mg\u002Fkg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days",[13,14],"Drug: TQD3524","Drug: Meropenem for injection",{"label":16,"type":17,"description":18,"interventionNames":19},"Colistimethate Sodium for Injection + Meropenem for injection (Low-dose control)","ACTIVE_COMPARATOR","Colistimethate Sodium for Injection: 2.5mg\u002Fkg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days",[14,20],"Drug: Colistimethate Sodium for Injection",{"label":22,"type":10,"description":23,"interventionNames":24},"High-dose TQD3524 + Meropenem for injection","TQD3524: 3.75mg\u002Fkg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days",[13,14],{"label":26,"type":17,"description":18,"interventionNames":27},"Colistimethate Sodium for Injection + Meropenem for injection (High-dose control)",[14,20],[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","TQD3524","After entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects .",[22,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Meropenem for injection","Meropenem for injection is a β-lactam.",[26,16,22,9],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Colistimethate Sodium for Injection","Colistimethate 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.",[26,16],[44],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Yanbin Liu, Doctor","CONTACT","18980601983","dr_liuyanbin@foxmail.com",[50,68,83,98,113,127,144,158,173,188,199,210,220,235,246,257,272,287,302,308,322,337,348,363,374,385,400],{"facility":51,"status":34,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The First Affiliated Hospital of Bengbu Medical College","Bengbu","Anhui","233000","China","CN",{"type":58,"coordinates":59},"Point",[60,61],117.36083,32.94083,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":66,"phoneExt":34,"email":67},"Shibing Zhao, Master","13855212871","zhaoshibing523@163.com",{"facility":69,"status":34,"city":70,"state":71,"zip":72,"country":55,"countryCode":56,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Beijing Tsinghua Changgung 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Hospital","Xianyang","712000",{"type":58,"coordinates":313},[314,315],108.70261,34.33778,{"lat":315,"lon":314},[318],{"name":319,"role":46,"phone":320,"phoneExt":34,"email":321},"Jianhou Jia, Master","13892007197","jjh20@126.com",{"facility":323,"status":34,"city":324,"state":325,"zip":326,"country":55,"countryCode":56,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Shanghai General Hospital","Shanghai","Shanghai Municipality","200080",{"type":58,"coordinates":328},[329,330],121.45806,31.22222,{"lat":330,"lon":329},[333],{"name":334,"role":46,"phone":335,"phoneExt":34,"email":336},"Min Zhang, Doctor","13482345145","maggie_zhangmin@163.com",{"facility":338,"status":34,"city":324,"state":325,"zip":339,"country":55,"countryCode":56,"cosmosGeoPoint":340,"geoPoint":342,"contacts":343},"Shanghai Pulmonary Hospital","200433",{"type":58,"coordinates":341},[329,330],{"lat":330,"lon":329},[344],{"name":345,"role":46,"phone":346,"phoneExt":34,"email":347},"Haiwen Lu, 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Hospital","610072",{"type":58,"coordinates":378},[355,356],{"lat":356,"lon":355},[381],{"name":382,"role":46,"phone":383,"phoneExt":34,"email":384},"Chun Pan, Doctor","13814009925","panchun1982@gmail.com",{"facility":386,"status":34,"city":387,"state":388,"zip":389,"country":55,"countryCode":56,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Tianjin Medical University General Hospital","Tianjin","Tianjin Municipality","300052",{"type":58,"coordinates":391},[392,393],117.17667,39.14222,{"lat":393,"lon":392},[396],{"name":397,"role":46,"phone":398,"phoneExt":34,"email":399},"Jie Cao, Master","13132088076","jiecao13995@163.com",{"facility":401,"status":34,"city":387,"state":388,"zip":402,"country":55,"countryCode":56,"cosmosGeoPoint":403,"geoPoint":405,"contacts":406},"Tianjin First Central Hospital","300191",{"type":58,"coordinates":404},[392,393],{"lat":393,"lon":392},[407],{"name":408,"role":46,"phone":409,"phoneExt":34,"email":410},"HongMei Gao, Doctor","13072256661","ghm182@163.com",{"type":412,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","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* Individuals with allergic reactions to polymyxins or carbapenems;\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":423,"type":424},48,"ESTIMATED","INTERVENTIONAL",[427],"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.",[430],"Hospital-acquired Bacterial Pneumonia\u002FVentilator-associated Bacterial Pneumonia","NOT_YET_RECRUITING","2026-07-16",{"date":434,"type":435},"2026-07-17","ACTUAL",{"date":437,"type":424},"2026-07",{"date":439,"type":424},"2027-07",{"name":5,"class":6},27]