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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Gram-Positive Bacterial Infections Cross Infection

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tigecycline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No