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Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

Primary Purpose

Gram-Positive Bacterial Infections, Cross Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tigecycline
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-Positive Bacterial Infections focused on measuring Bacterial Infections

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics Exclusion Criteria: Subjects who are moribund with an expected survival of less than 2 weeks. Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2004
    Last Updated
    February 7, 2013
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00081744
    Brief Title
    Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects
    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
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gram-Positive Bacterial Infections, Cross Infection
    Keywords
    Bacterial Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    850 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tigecycline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics Exclusion Criteria: Subjects who are moribund with an expected survival of less than 2 weeks. Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16236177
    Citation
    Oliva ME, Rekha A, Yellin A, Pasternak J, Campos M, Rose GM, Babinchak T, Ellis-Grosse EJ, Loh E; 301 Study Group. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]. BMC Infect Dis. 2005 Oct 19;5:88. doi: 10.1186/1471-2334-5-88.
    Results Reference
    result
    PubMed Identifier
    19036670
    Citation
    Fomin P, Koalov S, Cooper A, Babinchak T, Dartois N, De Vane N, Castaing N, Tellado J; 301 And 306 Study Groups. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience. J Chemother. 2008 Oct;20 Suppl 1:12-9. doi: 10.1179/joc.2008.20.Supplement-1.12.
    Results Reference
    derived

    Learn more about this trial

    Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

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