Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms (NCT00079989) | Clinical Trial Compass
CompletedPhase 3
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
115 participantsStarted 2003-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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)
Trial details
NCT IDNCT00079989
SponsorWyeth is now a wholly owned subsidiary of Pfizer