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Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00481962
Collaborator
(none)
180
Enrollment
1
Location
34
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost analysis from a hospital perspective (including length of stay, treatment costs, side effect management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10 score etc.); Efficacy of Tygacil under usual care conditions (cure rate).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

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:

    • Diagnosis of secondary peritonitis

    • Treatment in an ICU

    • Patient age >18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Multiple Cities Germany

    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
    • Principal Investigator: Trial Manager, For Germany, medinfoDEU@wyeth.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00481962
    Other Study ID Numbers:
    • 3074A1-102184
    First Posted:
    Jun 4, 2007
    Last Update Posted:
    Sep 28, 2009
    Last Verified:
    Sep 1, 2009
    Additional relevant MeSH terms:
    Peritonitis
    Tigecycline

    Study Results

    No Results Posted as of Sep 28, 2009