[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520050":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":232,"collaborators":25,"id":236,"slug":237,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":25,"eligibilityCriteria":242,"healthyVolunteers":238,"sex":243,"minAge":244,"maxAge":245,"enrollmentInfo":246,"targetDuration":25,"studyType":249,"phases":250,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"Southeast University, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"colistin group","EXPERIMENTAL","For patients in this group, colistin based therapy is used. Colistin combined with metroperan or imipenem（MIC≤8mg\u002FL），or colistin combined with tigecycline, or colistin combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.\n\nAt the beginning of the intravenous use of Colistimethate Sodium for Injection，the load dose is 300mg CBA(about 9 million U)，and after 12-24 hours，the first maintenance dose should be given. The daily maintenance dose was 300-360mg CBA(9 million-10.9 million U), divided into two times (1\u002F12h), for each time, 0.5-1 hour is needed to complete the infusion.\n\nDrug: colistin, other name: Colistimethate Sodium for Injection",[13],"Drug: treatment with or without colistin",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","ACTIVE_COMPARATOR","For patients in this group,best available treatment without colistin is used. Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem（MIC≤8mg\u002FL）, tigecycline combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.Dose of other drugs are listed below: 1-2g meropenem should be given every 8 hours，1g Imipenem every 8 hours or 6 hours，0.8g Amikacin everyday，2.5g ceftazidime-avibactam every 8 hours. A load dose of 200mg tigecycline is needed, followed by 100mg every 12 hours.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","treatment with or without colistin","For patients in this treatment group, colistin based therapy is used. Colistin combined with metroperan or imipenem（MIC≤8mg\u002FL），or colistin combined with tigecycline, or colistin combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae. For patients in the control, best available treatment without colistin is uesed; Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem（MIC≤8mg\u002FL）, tigecycline combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Yingzi Huang, MD","Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University","STUDY_CHAIR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+86-025-83262552","yz_huang@126.com",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":38},"Jianfeng Xie, MD","xie820405@126.com",[40,58,67,81,95,108,121,134,146,155,168,181,194,207,220],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Anhui Provincial People's Hospital","RECRUITING","Hefei","Anhui","230000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],117.28083,31.86389,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":25,"email":25},"Aijun, Pan","+8613866668786",{"facility":59,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"The First Hospital of Anhui Medical University",{"type":49,"coordinates":61},[51,52],{"lat":52,"lon":51},[64],{"name":65,"role":33,"phone":66,"phoneExt":25,"email":25},"Min Shao","+8615656065677",{"facility":68,"status":42,"city":69,"state":70,"zip":71,"country":46,"countryCode":47,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Jinjiang Municipal Hospitall","Jinjiang","Fujian","362200",{"type":49,"coordinates":73},[74,75],118.57415,24.81978,{"lat":75,"lon":74},[78],{"name":79,"role":33,"phone":80,"phoneExt":25,"email":25},"Sen Lin","+8618065956302",{"facility":82,"status":42,"city":83,"state":84,"zip":85,"country":46,"countryCode":47,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Huai'an First People's Hospital","Huai'an","Jiangsu","223000",{"type":49,"coordinates":87},[88,89],119.01917,33.58861,{"lat":89,"lon":88},[92],{"name":93,"role":33,"phone":94,"phoneExt":25,"email":25},"Xiangcheng Zhang","+8615896169171",{"facility":96,"status":42,"city":97,"state":84,"zip":98,"country":46,"countryCode":47,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The First Hospital of Lianyungang","Lianyungang","222000",{"type":49,"coordinates":100},[101,102],119.21556,34.59845,{"lat":102,"lon":101},[105],{"name":106,"role":33,"phone":107,"phoneExt":25,"email":25},"Suxia Liu","+8618961326708",{"facility":109,"status":42,"city":110,"state":84,"zip":111,"country":46,"countryCode":47,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Zhongda Hospital Affiliated to Southeast University","Nanjing","210000",{"type":49,"coordinates":113},[114,115],118.77778,32.06167,{"lat":115,"lon":114},[118],{"name":119,"role":33,"phone":120,"phoneExt":25,"email":35},"Yingzi Huang","+86-25-83262552",{"facility":122,"status":42,"city":123,"state":84,"zip":124,"country":46,"countryCode":47,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Affiliated Hospital of Nantong University","Nantong","226000",{"type":49,"coordinates":126},[127,128],120.87472,32.03028,{"lat":128,"lon":127},[131],{"name":132,"role":33,"phone":133,"phoneExt":25,"email":25},"Hongsheng Zhao","+8613962918910",{"facility":135,"status":42,"city":136,"state":84,"zip":137,"country":46,"countryCode":47,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Suzhou Municipal Hospitial","Suzhou","215000",{"type":49,"coordinates":139},[140,141],120.59538,31.30408,{"lat":141,"lon":140},[144],{"name":145,"role":33,"phone":25,"phoneExt":25,"email":25},"Liu Jun",{"facility":147,"status":42,"city":136,"state":84,"zip":137,"country":46,"countryCode":47,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"The First Affiliated Hospital of Soochow University",{"type":49,"coordinates":149},[140,141],{"lat":141,"lon":140},[152],{"name":153,"role":33,"phone":154,"phoneExt":25,"email":25},"Jun Jin","+8613806214010",{"facility":156,"status":42,"city":157,"state":84,"zip":158,"country":46,"countryCode":47,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"JiangsuTaizhou People's Hospital","Taizhou","225300",{"type":49,"coordinates":160},[161,162],119.90812,32.49069,{"lat":162,"lon":161},[165],{"name":166,"role":33,"phone":167,"phoneExt":25,"email":25},"Jilu Ye","+8613852609309",{"facility":169,"status":42,"city":170,"state":84,"zip":171,"country":46,"countryCode":47,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Wuxi No.2 People's Hospital","Wuxi","214000",{"type":49,"coordinates":173},[174,175],120.28857,31.56887,{"lat":175,"lon":174},[178],{"name":179,"role":33,"phone":180,"phoneExt":25,"email":25},"Liang Luo","+8615961790376",{"facility":182,"status":42,"city":183,"state":84,"zip":184,"country":46,"countryCode":47,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Xuzhou Central Hospital","Xuzhou","221000",{"type":49,"coordinates":186},[187,188],117.28386,34.20442,{"lat":188,"lon":187},[191],{"name":192,"role":33,"phone":193,"phoneExt":25,"email":25},"Jiaqiong Li","+8618952170393",{"facility":195,"status":42,"city":196,"state":84,"zip":197,"country":46,"countryCode":47,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Yancheng No.1 People's Hospital","Yancheng","224000",{"type":49,"coordinates":199},[200,201],120.1573,33.3575,{"lat":201,"lon":200},[204],{"name":205,"role":33,"phone":206,"phoneExt":25,"email":25},"Genghua Mu","+8613815584925",{"facility":208,"status":42,"city":209,"state":84,"zip":210,"country":46,"countryCode":47,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Northern Jiangsu People's Hospital","Yangzhou","225000",{"type":49,"coordinates":212},[213,214],119.43583,32.39722,{"lat":214,"lon":213},[217],{"name":218,"role":33,"phone":219,"phoneExt":25,"email":25},"Ruiqiang Zheng","+8613952721411",{"facility":221,"status":42,"city":222,"state":84,"zip":171,"country":46,"countryCode":47,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Yixing People's Hospital","Yixing",{"type":49,"coordinates":224},[225,226],119.82016,31.36059,{"lat":226,"lon":225},[229],{"name":230,"role":33,"phone":231,"phoneExt":25,"email":25},"Junjie Lu","+8613606157979",{"type":233,"investigatorFullName":234,"investigatorTitle":235,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Jianfeng Xie","Principal Investigator","100520050","efficacy-and-safety-of-colistimethate-sodium-for-injection-in-the-treatment-of-carbapenem-resistant-enterobacteriaceae-infection-100520050",false,"NCT06051513","Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection","Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection：a Prospective, Open-label, Randomized Controlled, Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Patients who can provide written informed consent or their informed consent can be provided by legal guardian\n2. Patients who are hospitalized\n3. Adults ≥18 years and ≤85 years of age\n4. Patients suspected of or diagnosed with hospital-acquired pneumonia (HAP, in a patient hospitalised for more than 48 hours or developing within 7 days after discharge from a hospital) or bloodstream infection caused carbapenem-resistant enterobacteriaceae (CRE) based on the culture results of the sample collected 5 days before the randomization or rapid diagnostic detection.\n\n   Rapid testing of respiratory or blood specimens should be used to enable early identification of CRE infection pneumonia. Patients can be randomized based on the results of the rapid test while awaiting results of cultures from the local laboratory. However, if the sample does not grow CRE in the local microbiology laboratory culture, these patients will be withdrawn from the study drug treatment.\n\n   Patients with HAP should fulfil one of the following systemic signs: 1)Fever (temperature \\>38°C) or hypothermia (rectal\u002Fcore temperature \\\u003C35°C);2)White blood cell (WBC) count \\>10,000 cells\u002Fmm3, or WBC count \\\u003C4500 cells\u002Fmm3, or \\>15% band forms and fulfil at least two of the following respiratory signs or symptoms:1)a new onset of cough (or worsening of cough);2)production of purulent sputum or endotracheal secretions;3)auscultatory findings consistent with pneumonia\u002Fpulmonary consolidation (e.g., rales, rhonchi, bronchial breath sounds, dullness to percussion, egophony);4)dyspnoea, tachypnoea or hypoxaemia (O2 saturation \\\u003C90% or pO2 \\\u003C60 mmHg while breathing room air).\n\n   Patients with bloodstream infection should fulfil one of the following criterion:1)fever(≥38 ℃);2)chills;3)hypotension(systolic \\\u003C90 mmHg, requiring vasopressors to maintain mean arterial pressure ≥60 mmHg,decreased by 30mmHg from baseline) ,and isolation of CRE from at least two blood culture collected from two different sites.\n5. Respiratory or blood specimen obtained for culture within 5 days prior to randomization, and after the onset of signs and symptoms of HAP or bloodstream infection (ideally before receipt of any systemic antibiotics).\n6. Patients whose APACHE II score is between 10 and 30.\n\nExclusion Criteria:\n\n1. Patients who received polymyxin for more than 48 hours in the 72 hours prior to randomization.\n2. Patients who received antibiotics more than 24 hours in the 72 hours prior to randomization, and after treatment，conditions of patients improved.\n3. Patient with history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to Colistimethate Sodium for Injection or other ingredients of it.\n4. Evidence of active concurrent pneumonia requiring additional antimicrobials treatment caused by Streptococcus pneumoniae，Haemophilus influenzae，Methicillin-resistant staphylococcus aureus，Vancomycin-resistant enterococcus，Mycoplasma pneumonia，Legionella pneumophila, respiratory syncytial virus, influenza virus, parainfluenza virus, Middle East Respiratory Virus, Mycobacteria, Aspergillus, Mucormycosis, Candida,etc. If these organisms are identified but it is deemed by the Investigator that no treatment is warranted and their presence does not significantly change the prognosis of the patient, then the patient may be considered for this study.\n5. Patients who are diagnosed with primary lung cancer (including small cell lung cancer\u002Fnon-small cell lung cancer patients) or other malignancy transferred to the lungs or other known post obstructive pneumonia. Patients who is known or suspected of active tuberculosis, cystic fibrosis, lung abscess, pyothorax or obstructive pneumonia.\n6. Patients with hematological malignancy such as leukemia, lymphoma and multiple myeloma.\n7. Patients with lung\u002Fheart transplantation or stem cell transplantation.\n8. Patient was immunocompromised and at risk of infection by opportunistic pathogens including, but not limited to the following:1) HIV (AIDS or CD4 \\\u003C200). 2) chemoradiotherapy within 3 months prior to randomisation. 3) Immunosuppressive therapy including maintenance corticosteroids (0.5 mg\u002Fkg prednisone per day or other equivalent glucocorticoid). 4) Absolute neutrophil count \\\u003C500\u002Fmm3.\n9. Patients with chronic liver failure with portal hypertension, acute hepatic failure or acute decompensation of chronic hepatic failure.\n10. Patients who participated in other clinical trials within three months.\n11. Patient was pregnant or breastfeeding. If either urine or serum β-hCG test was positive, the patient was excluded.\n12. Patient who have been previously enrolled in this study.\n13. Patients who have condionts that may affect the trial.\n14. Other conditions exist researchers thought are not suitable.","ALL","18 Years","85 Years",{"count":247,"type":248},404,"ESTIMATED","INTERVENTIONAL",[251],"NA","Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.",[254],"Carbapenem-Resistant Enterobacteriaceae Infection",[256,257,258,259],"Colistimethate Sodium for Injection","Hospital-acquired pneumonia","Bloodstream infection","Carbapenem-resistant Enterobacteriaceae","2025-05-14",{"date":262,"type":263},"2025-05-18","ACTUAL",{"date":265,"type":263},"2023-11-27",{"date":267,"type":248},"2025-12-31",{"name":5,"class":6},15]