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Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00079885
Collaborator
(none)
430
Enrollment
20
Duration (Months)

Study Details

Study Description

Brief Summary

To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
430 participants
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
Study Start Date :
Nov 1, 2003
Actual Primary Completion Date :
Jul 1, 2005
Actual Study Completion Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female subjects ≥ 18 years of ag.

    • Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated

    • The presence of fever (within 24 hours prior to randomization), defined as oral temperature >38°C/100.4°F, axillary temperature >38.1°C/100.6°F, tympanic temperature

    38.5°C/ 101.2°F, or a rectal/core temperature >39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature <35°C/95°

    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 (eg, life expectancy <30 days)

    • Hospitalization within 14 days prior to the onset of symptoms

    • Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

    • Study Director: Medical Monitor, MD, Wyeth is now a wholly owned subsidiary of Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wyeth is now a wholly owned subsidiary of Pfizer
    ClinicalTrials.gov Identifier:
    NCT00079885
    Other Study ID Numbers:
    • 3074A1-308
    First Posted:
    Mar 19, 2004
    Last Update Posted:
    Feb 8, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
    Bacterial Pneumonia
    Additional relevant MeSH terms:
    Pneumonia
    Pneumonia, Bacterial
    Cross Infection
    Tigecycline

    Study Results

    No Results Posted as of Feb 8, 2013