Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

NCT ID: NCT00575094

Last Updated: 2011-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-03-31

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.

Conditions

Community-Acquired Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

tigecycline

Dosage form: Tigecycline 50 mg for injection (Lyophilized powder in 5 mL vial) Dosage frequency: Tigecycline 100 mg loading followed by 50 mg every 12 hrs (bid) Duration of therapy: 7 to 14 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Wyeth

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Toyota-shi, Aichi-ken, Japan

Kurume-shi, Fukuoka, Japan

Yanagawa-shi, Fukuoka, Japan

Asahikawa-shi, Hokkaido, Japan

Funaishikawa, Ibaraki, Japan

Yokohama, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Suwa-shi, Nagano, Japan

Kiyose-shi, Tokyo, Japan

Countries

Japan

Other Identifiers

3074A1-3331

Identifier Type: -

Identifier Source: org_study_id