NCT00575094

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 27, 2009

Completed
Last Updated

June 3, 2011

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

December 13, 2007

Results QC Date

March 31, 2009

Last Update Submit

June 2, 2011

Conditions

Community-Acquired Infections

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

tigecyclineDRUG

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Toyota-shi, Aichi-ken, 471-8513, Japan

Location

Unknown Facility

Kurume-shi, Fukuoka, 830-8543, Japan

Location

Unknown Facility

Yanagawa-shi, Fukuoka, 832-0059, Japan

Location

Unknown Facility

Asahikawa-shi, Hokkaido, 070-8644, Japan

Location

Unknown Facility

Funaishikawa, Ibaraki, 319-1113, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 230-0012, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 236-0051, Japan

Location

Unknown Facility

Suwa-shi, Nagano, 392-8510, Japan

Location

Unknown Facility

Kiyose-shi, Tokyo, 204-8585, Japan

Location

MeSH Terms

Conditions

Community-Acquired Infections

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 17, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

June 3, 2011

Results First Posted

May 27, 2009

Record last verified: 2011-06

Locations

JP(9)