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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00081744

Collaborator

(none)

850

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gram-Positive Bacterial Infections Cross Infection	Drug: Tigecycline	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

850 participants

Allocation:

Randomized

Masking:

Double

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 :

Nov 1, 2002

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts 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