Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
NCT00081575
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- Male and female subjects ≥ 18 years of age and in Bulgaria only ≤ 70 years of age
- Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment for at least 7 days
- The presence of fever (within 24 hours before randomization)
- Any concomitant condition that, in the opinion of the investigator, would preclude an
evaluation of a response or make it unlikely that the contemplated course of therapy
could be completed (eg, life expectancy <30 days).
- Hospitalization within 14 days before the onset of symptoms.
- Residence in a long-term care facility or nursing home ≥14 days before the onset of
symptoms.
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Descriptive Information | ||||
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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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
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. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 434 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | March 2005 | |||
Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Germany, Hungary, India, Latvia, Lithuania, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00081575 | |||
Other Study ID Numbers ICMJE | 3074A1-313 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |