[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608837":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":44,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":26},{"fullName":5,"class":6},"Henan University of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test group","EXPERIMENTAL","The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag\u002Ftime, 3 times\u002Fday).",[13],"Drug: Fei Re Qing Granules",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","The patients in the control group received routine standard treatments, and Placebo granules",[19],"Drug: Placebo of Feireqing Granules",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fei Re Qing Granules","Fei Re Qing Granules (Ingredients: Scutellaria baicalensis \\[Huang Qin\\], Trichosanthes kirilowii \\[Gua Lou\\], Forsythia suspensa \\[Lian Qiao\\], Fritillaria thunbergii \\[Zhe Bei Mu\\], etc.).\n\nRoutine standard treatments：Routine standard treatments according to clinical guidelines.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo of Feireqing Granules","Placebo of Feireqing Granules：The placebo granules are prepared using 5% of the active drug combined with pharmaceutical excipients, including starch, dextrin, microcrystalline cellulose, and food-grade coloring and flavoring agents, to ensure consistency in appearance, weight, color, and odor with the Fei Re Qing Granules.\n\nRoutine standard treatments：Routine standard treatments according to clinical guidelines.",[15],[32],{"name":33,"affiliation":34,"role":35},"Jiansheng Li, Doctor","The First Affiliated Hospital of Henan University of Traditional Chinese Medicine","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Zhenzhen Feng, Doctor","CONTACT","+86 15890658268","huxifzz@163.com",{"type":43,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[45,48,50,52,54],{"name":46,"class":47},"Henan Provincial Hospital of TCM","UNKNOWN",{"name":49,"class":6},"Third Affiliated Hospital of Henan University of Traditional Chinese Medicine",{"name":51,"class":6},"Henan Provincial People's Hospital",{"name":53,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":34,"class":6},"100608837","a-study-on-integrated-chinese-and-western-medicine-for-severe-pneumonia-caused-by-multidrug-resistant-gram-negative-bacterial-infections-100608837",false,"NCT07206745","A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections","Efficacy Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Meeting the diagnostic criteria for severe pneumonia, aged ≥18 years and \\\u003C80 years;\n* Microbiological culture confirming Gram-negative bacterial infection resistant to three or more classes of antibiotics, such as extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii (CRAB), and multidrug-resistant Pseudomonas aeruginosa (MDR-PA);\n* Written informed consent obtained from the patient or their legal representative.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Patients with impaired consciousness, dementia, psychiatric disorders, or other conditions that preclude effective communication and cooperation;\n* Patients with aspiration pneumonia, fungal pneumonia, viral pneumonia, pulmonary tuberculosis, or HIV-associated Pneumocystis jirovecii pneumonia;\n* Patients with severe hepatic or renal insufficiency, such as liver cirrhosis with Child-Pugh score of 10-15, or estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n* Patients with hematologic malignancies, solid organ transplantation, or congenital\u002Facquired diseases leading to immunodeficiency;\n* Patients with multidrug-resistant bacterial infections outside the lung (e.g., urinary tract, abdominal cavity, bloodstream);\n* Patients with severe cardiac dysfunction (NYHA class IV), malignant arrhythmias, or other hemodynamically unstable conditions;\n* Patients who have already received antimicrobial therapy for more than one week;\n* Patients who have participated in another drug clinical trial within one month prior to enrollment;\n* Patients with known allergy to the investigational drug.","ALL","18 Years","80 Years",{"count":66,"type":67},152,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study aims to evaluate the clinical efficacy of a traditional Chinese medicine formula granule (Feireqing Granules) in the treatment of severe pneumonia caused by multidrug-resistant Gram-negative bacterial infections (MDR-GNB severe pneumonia), to establish a therapeutic regimen, and to generate high-quality clinical evidence.",[73],"Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection",[75,76,77,78,23],"Severe pneumonia","multidrug-resistant Gram-negative bacterial infection","traditional Chinese medicine","randomized controlled trial","NOT_YET_RECRUITING","2025-09-26",{"date":82,"type":83},"2025-10-03","ACTUAL",{"date":85,"type":67},"2025-10-01",{"date":87,"type":67},"2027-12-31",{"name":5,"class":6}]