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Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
This study has been completed.
Study NCT00079989   Information provided by Wyeth
First Received: March 19, 2004   Last Updated: October 9, 2007   History of Changes

March 19, 2004
October 9, 2007
 
 
 
 
Complete list of historical versions of study NCT00079989 on ClinicalTrials.gov Archive Site
 
 
 
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
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

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.

 
Phase III
Interventional
Treatment, Open Label, Safety/Efficacy Study
Gram-Negative Bacterial Infections
Drug: tigecycline
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00079989
 
3074A1-309
Wyeth
 
Study Director: Medical Monitor, MD Wyeth
Wyeth
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP