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

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

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00081744

Purpose

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

Condition	Intervention	Phase
Gram-Positive Bacterial Infections Cross Infection	Drug: Tigecycline	Phase III

MedlinePlus related topics:

Bacterial Infections

ChemIDplus related topics:

Tigecycline Cilastatin Cilastatin sodium Imipenem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Safety/Efficacy Study

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081744

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Publications of Results:

Study ID Numbers:	3074A1-301
First Received:	April 19, 2004
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00081744
Health Authority:	United States: Food and Drug Administration