A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
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.
1 other identifier
interventional
470
1 country
47
Brief Summary
This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2012
Typical duration for phase_4
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
April 9, 2018
CompletedApril 9, 2018
September 1, 2017
2.9 years
October 31, 2012
September 29, 2016
September 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population
The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population
The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Secondary Outcomes (2)
Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population
Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Microbiological Response at the Subject Level in the ME Population at the TOC Assessment
Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Other Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness
From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)
Study Arms (2)
Group A
EXPERIMENTALGroup B
ACTIVE COMPARATORInterventions
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.
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
You may qualify if:
- Hospitalized male or female subjects, at least 18 year of age.
- 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.
You may not qualify if:
- Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (47)
Anqing City Hospital
Anqing, Anhui, 246003, China
Department of Hepatobiliary Surgery, Peking University People's Hospital
Xicheng District, Beijing Municipality, 100044, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000, China
Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital of JiNan University/General Surgery
Guangzhou, Guangdong, 510630, China
The First Hospital of Shantou University School of Medicine
Shantou, Guangdong, 515041, China
Shenzhen Second People's Hosptial/Department of hepatobiliary surgery
Shenzhen, Guangdong, 518039, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
HaiKou Municipal People's Hospital
Haikou, Hainan, 570208, China
Hainan Provincial People's Hospital
Haikou, Hainan, 570311, China
The Third People's Hospital of Hainan Province/department of general surgery
Sanya, Hainan, 572000, China
Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Zhongnan Hospital of Wuhan University/Intensive Care Unit
Wuhan, Hubei, 430071, China
Xiangya Hospital Central-South University/General Surgery
Changsha, Hunan, 410008, China
The Third Xiangya Hospital of Central South University/Department of General Surgery
Changsha, Hunan, 410013, China
The Third Hospital of Changsha/Department of Surgery
Changsha, Hunan, 410015, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014000, China
The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department
Jiangyin, Jiangsu, 214400, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Yangzhou No.1 People's Hospital
Yangzhou, Jiangsu, 225001, China
Jilin Province People's Hospital
Changchun, Jilin, 130021, China
The First Hospital of Jilin University/Surgery
Changchun, Jilin, 130021, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256603, China
Shanghai Fengxian District Central Hospital, Department of Surgery
Shanghai, Shanghai Municipality, 201400, China
Department of General Surgery, Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
General Hospital of Chengdu Military Region of PLA
Chengdu, Sichuan, 610083, China
First people's Hospital of Kunming
Kunming, Yunnan, 650011, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000, China
Lishui People's Hospital/Intensive Care Unit
Lishui, Zhejiang, 323000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
China Meitan General Hospital/General Surgery Department
Beijing, 100028, China
Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University
Beijing, 100038, China
Navy General Hospital PLA China/Genaral Surgery Department
Beijing, 100048, China
Peking University Third Hospital
Beijing, 100191, China
Department of General Surgery, Peking Union Medical College Hospital
Beijing, 100730, China
Institute of Antibiotics, Hua Shan Hospital, Fudan University
Shanghai, 200040, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,
Shanghai, 201700, China
Tianjin Union Medical Center
Tianjin, 300000, China
Department of General Surgery, Tianjin Medical University General Hospital
Tianjin, 300052, China
Tianjin Nankai Hospital
Tianjin, 300100, China
Related Publications (1)
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.
PMID: 30584308DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 5, 2012
Study Start
November 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
April 9, 2018
Results First Posted
April 9, 2018
Record last verified: 2017-09