Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01721408
First received: October 31, 2012
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.


Condition Intervention Phase
Intra-abdominal Infection
Drug: Tigecycline
Drug: Imipenem/cilastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants with Clinical Response at Test-of-Cure (TOC) Visit [ Time Frame: 14-21 days after last dose of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response at the test-of-cure assessment for the microbiologically evaluable (ME) population [ Time Frame: 14-21 days after last dose of therapy ] [ Designated as safety issue: No ]
  • Microbiological response by baseline isolate for the ME and m-mITT populations [ Time Frame: 14-21 days after last dose of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 470
Study Start Date: November 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: 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.
Active Comparator: Group B Drug: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721408

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
China, Beijing
Department of Hepatobiliary Surgery, Peking University People's Hospital Recruiting
Xicheng District, Beijing, China, 100044
China, Guangdong
Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
China, Hainan
The Third People's Hospital of Hainan Province/department of general surgery Not yet recruiting
Sanya, Hainan, China, 572000
China, Hubei
Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
China, Hunan
The Third Xiangya Hospital of Central South University/Department of General Surgery Recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
The Second Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215004
The First Affiliated Hospital of Soochow University/General Surgery Department Recruiting
Suzhou, Jiangsu, China, 215006
China, Sichuan
Department of General Surgery, Sichuan Provincial People's Hospital Recruiting
Chengdu, Sichuan, China, 610072
General Hospital of Chengdu Military Region of PLA Recruiting
Chengdu, Sichuan, China, 610083
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
China
Peking University Third Hospital Recruiting
Beijing, China, 100191
Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University Recruiting
Beijing, China, 100038
Department of Hepatology, Peking University People's Hospital Baitasi Branch Recruiting
Beijing, China, 100034
Department of General Surgery, Peking Union Medical College Hospital Terminated
Beijing, China, 100730
Institute of Antibiotics, Hua Shan Hospital, Fudan University Recruiting
Shanghai, China, 200040
Renji Hospital Shanghai Jiaotong University School of Medicne Not yet recruiting
Shanghai, China, 200127
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200092
Zhongshan Hospital, Fudan University/Department of General Surgery Not yet recruiting
Shanghai, China, 200032
Department of General Surgery, Tianjin Medical University General Hospital Recruiting
Tianjin, China, 300052
Tianjin Nankai Hospital Recruiting
Tianjin, China, 300100
Tianjin Union Medical Center Recruiting
Tianjin, China, 300000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01721408     History of Changes
Other Study ID Numbers: B1811185
Study First Received: October 31, 2012
Last Updated: November 20, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Infection
Intraabdominal Infections
Cilastatin
Imipenem
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014