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.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01721408
First received: October 31, 2012
Last updated: May 22, 2013
Last verified: May 2013
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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: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721408
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| China, Guangdong | |
| Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University | Not yet recruiting |
| Guangzhou, Guangdong, China, 510120 | |
| China, Hunan | |
| The Third Xiangya Hospital of Central South University | Recruiting |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| The Second Affiliated Hospital of Soochow University/General Surgery Department | Recruiting |
| Suzhou, Jiangsu, China, 215004 | |
| China, Sichuan | |
| Department of General Surgery, Sichuan Provincial People's Hospital | Recruiting |
| Chengdu, Sichuan, China, 610072 | |
| China, Zhejiang | |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310003 | |
| China | |
| Peking University Third Hospital | Recruiting |
| Beijing, China, 100191 | |
| Institute of Antibiotics, Hua Shan Hospital, Fudan University | Not yet recruiting |
| Shanghai, China, 200040 | |
| Renji Hospital Shanghai Jiao Tong University School of Medicine | Not yet recruiting |
| Shanghai, China, 200127 | |
| Zhongshan Hospital, Fudan University | Not yet recruiting |
| Shanghai, China, 200032 | |
| 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: | May 22, 2013 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cilastatin Imipenem Tigecycline Minocycline Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013