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

Community-Acquired Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575094
• Other study ID #: 3074A1-3331
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2007
• Last updated: June 2, 2011
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: June 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-Acquired Infections

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No