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

A Phase 3, Multicenter, Open-label Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects With Community-acquired Pneumonia

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 Overview

• Status: Completed
• Conditions: Community-Acquired Infections
• Intervention / Treatment: Drug: tigecycline

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Toyota-shi, Aichi, Japan, 471-8513
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-8543
    • Yanagawa-shi, Fukuoka, Japan, 832-0059
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8644
  • Ibaraki
    • Tokai-mura, Ibaraki, Japan, 319-1113
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 230-0012
    • Yokohama-shi, Kanagawa, Japan, 236-0051
  • Nagano
    • Suwa-shi, Nagano, Japan, 392-8510
  • Tokyo
    • Kiyose-shi, Tokyo, Japan, 204-8585

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.	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.	8 weeks

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 17, 2007

Study Record Updates

• Last Update Posted (Estimate): June 3, 2011
• Last Update Submitted That Met QC Criteria: June 2, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Community-Acquired Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Tigecycline
• Other Study ID Numbers: 3074A1-3331