Clinical Trial: Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3, Multicenter, Open-label Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects With Community-acquired Pneumonia
Brief Summary: To purpose of this study is to assess the safety and tolerability of intravenous (IV) tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia (CAP).
Detailed Summary: This is a multicenter, open-label study evaluating the safety and efficacy of tigecycline in the treatment of Japanese subjects with CAP. Subjects with clinical signs and symptoms of CAP who meet the eligibility requirements will be considered for enrollment. Qualifying subjects will be assigned to receive tigecycline via IV administration for 7 to 14 consecutive days. The exact duration of administration of the study drug will be at the discretion of the investigator, based on the subject's condition. Subjects will be followed for safety until the test-of-cure (TOC) assessment 10 to 21 days after the last dose of therapy, and for efficacy until TOC assessment.
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome: Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. [ Time Frame: 8 weeks ]
Original Primary Outcome: Evaluate the safety, efficacy, and tolerability of tigecycline in the treatment of Japanese subjects with CAP [ Time Frame: 15 months ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: December 13, 2007
Date Started: November 2007
Date Completion:
Last Updated: June 2, 2011
Last Verified: June 2011