Back to resultsA Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Primary Purpose
Intra-abdominal Infection
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tigecycline
Imipenem/cilastatin
Sponsored by
About this trial
This is an interventional treatment trial for Intra-abdominal Infection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Anqing City Hospital
- Department of Hepatobiliary Surgery, Peking University People's Hospital
- Zhongshan Hospital Xiamen University
- Zhangzhou Municipal Hospital of Fujian Province
- Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University
- The First Affiliated Hospital of JiNan University/General Surgery
- The First Hospital of Shantou University School of Medicine
- Shenzhen Second People's Hosptial/Department of hepatobiliary surgery
- Affiliated Hospital of Guilin Medical University
- HaiKou Municipal People's Hospital
- Hainan Provincial People's Hospital
- The Third People's Hospital of Hainan Province/department of general surgery
- Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Zhongnan Hospital of Wuhan University/Intensive Care Unit
- Xiangya Hospital Central-South University/General Surgery
- The Third Xiangya Hospital of Central South University/Department of General Surgery
- The Third Hospital of Changsha/Department of Surgery
- Baotou Central Hospital
- The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department
- The Second Affiliated Hospital of Soochow University
- The First Affiliated Hospital of Soochow University
- Yangzhou No.1 People's Hospital
- Jilin Province People's Hospital
- The First Hospital of Jilin University/Surgery
- The Second Hospital of Jilin University
- Qinghai Provincial People's Hospital
- Binzhou Medical University Hospital
- Shanghai Fengxian District Central Hospital, Department of Surgery
- Department of General Surgery, Sichuan Provincial People's Hospital
- General Hospital of Chengdu Military Region of PLA
- First people's Hospital of Kunming
- The First Affiliated Hospital of College of Medicine, Zhejiang University
- Taizhou Hospital of Zhejiang Province
- Lishui People's Hospital/Intensive Care Unit
- The First Affiliated Hospital of Wenzhou Medical University
- China Meitan General Hospital/General Surgery Department
- Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University
- Navy General Hospital PLA China/Genaral Surgery Department
- Peking University Third Hospital
- Department of General Surgery, Peking Union Medical College Hospital
- Institute of Antibiotics, Hua Shan Hospital, Fudan University
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,
- Tianjin Union Medical Center
- Department of General Surgery, Tianjin Medical University General Hospital
- Tianjin Nankai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) 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).
Microbiological Response at the Subject Level in the ME Population at the TOC Assessment
The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01721408
Brief Title
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-abdominal Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Imipenem/cilastatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population
Description
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).
Time Frame
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)
Title
Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population
Description
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).
Time Frame
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)
Title
Microbiological Response at the Subject Level in the ME Population at the TOC Assessment
Description
The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.
Time Frame
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 Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness
Description
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Time Frame
From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Anqing City Hospital
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246003
Country
China
Facility Name
Department of Hepatobiliary Surgery, Peking University People's Hospital
City
Xicheng District
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Zhangzhou Municipal Hospital of Fujian Province
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Facility Name
Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The First Affiliated Hospital of JiNan University/General Surgery
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
The First Hospital of Shantou University School of Medicine
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Shenzhen Second People's Hosptial/Department of hepatobiliary surgery
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518039
Country
China
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Facility Name
HaiKou Municipal People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570208
Country
China
Facility Name
Hainan Provincial People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
The Third People's Hospital of Hainan Province/department of general surgery
City
Sanya
State/Province
Hainan
ZIP/Postal Code
572000
Country
China
Facility Name
Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Zhongnan Hospital of Wuhan University/Intensive Care Unit
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Xiangya Hospital Central-South University/General Surgery
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Third Xiangya Hospital of Central South University/Department of General Surgery
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The Third Hospital of Changsha/Department of Surgery
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410015
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014000
Country
China
Facility Name
The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Yangzhou No.1 People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Hospital of Jilin University/Surgery
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Qinghai Provincial People's Hospital
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810007
Country
China
Facility Name
Binzhou Medical University Hospital
City
Bin Zhou
State/Province
Shandong
ZIP/Postal Code
256603
Country
China
Facility Name
Shanghai Fengxian District Central Hospital, Department of Surgery
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201400
Country
China
Facility Name
Department of General Surgery, Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
General Hospital of Chengdu Military Region of PLA
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
Facility Name
First people's Hospital of Kunming
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650011
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
Lishui People's Hospital/Intensive Care Unit
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
China Meitan General Hospital/General Surgery Department
City
Beijing
ZIP/Postal Code
100028
Country
China
Facility Name
Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University
City
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
Navy General Hospital PLA China/Genaral Surgery Department
City
Beijing
ZIP/Postal Code
100048
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Department of General Surgery, Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Institute of Antibiotics, Hua Shan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,
City
Shanghai
ZIP/Postal Code
201700
Country
China
Facility Name
Tianjin Union Medical Center
City
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Department of General Surgery, Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Nankai Hospital
City
Tianjin
ZIP/Postal Code
300100
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30584308
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1811185&StudyName=A%20Study%20To%20Determine%20The%20Efficacy%20And%20Safety%20Of%20Tigecycline%20Compared%20With%20Imipenem/Cliastatin%20to%20Treat%20Complicated%20Intra-Abdominal%20Infection
Description
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A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
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