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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT00079989 |
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Date of registration:
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19/03/2004 |
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Primary sponsor: |
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Public title:
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Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
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Scientific title:
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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 |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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115 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00079989 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gram-Negative Bacterial Infections
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Intervention(s)
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Drug: tigecycline
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Secondary ID(s)
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3074A1-309
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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