A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
NCT ID: NCT01721408
Last Updated: 2018-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
470 participants
INTERVENTIONAL
2012-11-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
Tigecycline
every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.
Group B
Imipenem/cilastatin
every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.
Interventions
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Tigecycline
every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.
Imipenem/cilastatin
every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.
Eligibility Criteria
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Inclusion Criteria
* Complicated intra-abdominal infection is present at most under two weeks duration.
* Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.
Exclusion Criteria
* Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
* Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anqing City Hospital
Anqing, Anhui, China
Department of Hepatobiliary Surgery, Peking University People's Hospital
Xicheng District, Beijing Municipality, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of JiNan University/General Surgery
Guangzhou, Guangdong, China
The First Hospital of Shantou University School of Medicine
Shantou, Guangdong, China
Shenzhen Second People's Hosptial/Department of hepatobiliary surgery
Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
HaiKou Municipal People's Hospital
Haikou, Hainan, China
Hainan Provincial People's Hospital
Haikou, Hainan, China
The Third People's Hospital of Hainan Province/department of general surgery
Sanya, Hainan, China
Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University/Intensive Care Unit
Wuhan, Hubei, China
Xiangya Hospital Central-South University/General Surgery
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University/Department of General Surgery
Changsha, Hunan, China
The Third Hospital of Changsha/Department of Surgery
Changsha, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department
Jiangyin, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Yangzhou No.1 People's Hospital
Yangzhou, Jiangsu, China
Jilin Province People's Hospital
Changchun, Jilin, China
The First Hospital of Jilin University/Surgery
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Shanghai Fengxian District Central Hospital, Department of Surgery
Shanghai, Shanghai Municipality, China
Department of General Surgery, Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
General Hospital of Chengdu Military Region of PLA
Chengdu, Sichuan, China
First people's Hospital of Kunming
Kunming, Yunnan, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
Lishui People's Hospital/Intensive Care Unit
Lishui, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
China Meitan General Hospital/General Surgery Department
Beijing, , China
Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University
Beijing, , China
Navy General Hospital PLA China/Genaral Surgery Department
Beijing, , China
Peking University Third Hospital
Beijing, , China
Department of General Surgery, Peking Union Medical College Hospital
Beijing, , China
Institute of Antibiotics, Hua Shan Hospital, Fudan University
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,
Shanghai, , China
Tianjin Union Medical Center
Tianjin, , China
Department of General Surgery, Tianjin Medical University General Hospital
Tianjin, , China
Tianjin Nankai Hospital
Tianjin, , China
Countries
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References
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Chen Y, Zhu D, Zhang Y, Zhao Y, Chen G, Li P, Xu L, Yan P, Hickman MA, Xu X, Tawadrous M, Wible M. A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China. Ther Clin Risk Manag. 2018 Nov 30;14:2327-2339. doi: 10.2147/TCRM.S171821. eCollection 2018.
Related Links
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Other Identifiers
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B1811185
Identifier Type: -
Identifier Source: org_study_id
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