Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Clinical response: Cure=all initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR)improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.
|Study Start Date:||November 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
|Toyota-shi, Aichi, Japan, 471-8513|
|Kurume-shi, Fukuoka, Japan, 830-8543|
|Yanagawa-shi, Fukuoka, Japan, 832-0059|
|Asahikawa-shi, Hokkaido, Japan, 070-8644|
|Tokai-mura, Ibaraki, Japan, 319-1113|
|Yokohama-shi, Kanagawa, Japan, 236-0051|
|Yokohama-shi, Kanagawa, Japan, 230-0012|
|Suwa-shi, Nagano, Japan, 392-8510|
|Kiyose-shi, Tokyo, Japan, 204-8585|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|