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

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

This study has been completed.

Study NCT00081744. Last updated on May 17, 2006. Information provided by Wyeth

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Safety/Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Gram-Positive Bacterial Infections
Cross Infection

Intervention ^†

Drug: Tigecycline

MEDLINE PMIDs

16236177

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

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

Gender

Both

Ages

8 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00081744

Organization ID

3074A1-301

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

May 2006

First Received Date ^†

April 19, 2004

Last Updated Date

May 17, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.