Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms

This study has been completed.

First Received: March 19, 2004 Last Updated: October 9, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00079989

Purpose

To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.

Condition	Intervention	Phase
Gram-Negative Bacterial Infections	Drug: tigecycline	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety/Efficacy Study
Official Title:	A Phase 3, Open-Label, Noncomparative Study of Tigecycline for the Treatment of Subjects With Selected Serious Infections Due to Resistant Gram-Negative Organisms Such as Enterobacter Species, Acinetobacter Baumannii, and Klebsiella Pneumoniae

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Pneumonia

Drug Information available for: Tigecycline

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects aged 18 years or older
Isolation of a resistant gram-negative pathogen, eg, Enterobacter species, Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate of a polymicrobial infection
Resistant gram-negative organisms are defined by the likely presence of ESBL or related mechanisms which limit the therapeutic alternatives for the treatment of complicated infections

Exclusion Criteria:

Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
Anticipated length of antibiotic therapy < 7 days
Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079989

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3074A1-309
Study First Received:	March 19, 2004
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00079989 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Tigecycline

Therapeutic Uses
Infection
Pharmacologic Actions
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on November 27, 2009