Back to resultsStudy Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Primary Purpose
Community-Acquired Infections
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tigecycline
Sponsored by
About this trial
This is an interventional treatment trial for Community-Acquired Infections
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00575094
First Posted
December 13, 2007
Last Updated
June 2, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00575094
Brief Title
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
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tigecycline
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Toyota-shi
State/Province
Aichi
ZIP/Postal Code
471-8513
Country
Japan
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-8543
Country
Japan
City
Yanagawa-shi
State/Province
Fukuoka
ZIP/Postal Code
832-0059
Country
Japan
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
City
Tokai-mura
State/Province
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
230-0012
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
City
Suwa-shi
State/Province
Nagano
ZIP/Postal Code
392-8510
Country
Japan
City
Kiyose-shi
State/Province
Tokyo
ZIP/Postal Code
204-8585
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
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