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

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.

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Key information

Conditions

Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tigecycline

Drug

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Mar 23, 2004
Registry last updated: Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed