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

This study has been completed.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: March 19, 2004
Last updated: February 7, 2013
Last verified: February 2013
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 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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:

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

Enrollment: 115
Study Start Date: December 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00079989

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00079989     History of Changes
Other Study ID Numbers: 3074A1-309
Study First Received: March 19, 2004
Last Updated: February 7, 2013

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

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2017