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

This study has been completed.

First Received on April 19, 2004. Last Updated on May 17, 2006 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Imipenem Cilastatin sodium Cilastatin Tigecycline

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor, MD

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Cross Infection
Gram-Positive Bacterial Infections
Infection
Cilastatin
Imipenem
Tigecycline

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012