Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects - Full Text View

Purpose

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).

Condition	Intervention	Phase
Community-Acquired Infections	Drug: tigecycline	Phase 3

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Tigecycline

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

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.

Enrollment:	9
Study Start Date:	November 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575094

Locations

Japan

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

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00575094 History of Changes
Other Study ID Numbers:	3074A1-3331
Study First Received:	December 13, 2007
Results First Received:	March 31, 2009
Last Updated:	June 2, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Community-Acquired Infections
Infection
Tigecycline
Minocycline

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013