Clinical trial NCT00575094: Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community-Acquired Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized Japanese descent subjects known or suspected to have CAP with a severity that requires IV antibiotic treatment.
* Chest radiograph within 48 hours before the first dose of IV test article showing the presence of a new infiltrate.
* The presence of fever or hypothermia within 24 hours before the first administration of test article, and of at least two signs/symptoms of CAP within 24 hours before the first administration of test article.

Exclusion Criteria:

* 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.
* Hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of safety and efficacy of tigecycline.
* Known or suspected hypersensitivity to tigecycline or tetracyclines, or contraindication for these antibiotics.

Primary outcomes:
measure: Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toyota-shi
country: Japan
state: Aichi
city: Kurume-shi
country: Japan
state: Fukuoka
city: Yanagawa-shi
country: Japan
state: Fukuoka
city: Asahikawa-shi
country: Japan
state: Hokkaido
city: Tokai-mura
country: Japan
state: Ibaraki
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Suwa-shi
country: Japan
state: Nagano
city: Kiyose-shi
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: