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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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ClinicalTrials.gov Identifier: NCT01721408
Recruitment Status : Completed
First Posted : November 5, 2012
Last Update Posted : March 23, 2016
Information provided by (Responsible Party):

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : November 2012
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of Participants with Clinical Response at Test-of-Cure (TOC) Visit [ Time Frame: 14-21 days after last dose of therapy ]

Secondary Outcome Measures :
  1. Clinical response at the test-of-cure assessment for the microbiologically evaluable (ME) population [ Time Frame: 14-21 days after last dose of therapy ]
  2. Microbiological response by baseline isolate for the ME and m-mITT populations [ Time Frame: 14-21 days after last dose of therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721408

  Show 48 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01721408     History of Changes
Other Study ID Numbers: B1811185
First Posted: November 5, 2012    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Communicable Diseases
Intraabdominal Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action