Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00081575
First received: April 15, 2004
Last updated: October 9, 2007
Last verified: October 2007
Tracking Information | |||||
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First Received Date ICMJE | April 15, 2004 | ||||
Last Updated Date | October 9, 2007 | ||||
Start Date ICMJE | September 2003 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00081575 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia | ||||
Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia | ||||
Brief Summary | To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00081575 | ||||
Other Study ID Numbers ICMJE | 3074A1-313 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
Verification Date | October 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |