Status:
COMPLETED
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Gram-Negative Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00079989
Start Date
December 1 2003
End Date
November 1 2005
Last Update
February 8 2013
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