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

Phase 3

Completed

• Conditions: Gram-Negative Bacterial Infections

• Registration Number: NCT00079989
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2004-03-19
• Study First Submitted QC: 2004-03-22
• Study First Posted: 2004-03-23
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified