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Telavancin Observational Use Registry (TOUR)

Sponsor
Cumberland Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02288234
Collaborator
(none)
1,063
Enrollment
1
Location
35
Actual Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.

Condition or Disease Intervention/Treatment Phase

Detailed Description

This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.

Study Design

Study Type:
Observational
Actual Enrollment :
1063 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Telavancin Observational Use Registry (TOUR)
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Vibativ

This is an observational study for patients who were already prescribed Vibativ.

Drug: Vibativ
This is an observational study for patients who were already prescribed Vibativ.
Other Names:
  • telavancin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to clinical response [6 months]

      defined as the number of days between initiation of telavancin therapy and date of cure, where cure is defined as the resolution of the signs and symptoms of infection and/or no need for additional antibiotic therapy, or clearance of the infection with a negative culture result [Mohr 2009]

    Secondary Outcome Measures

    1. Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs) [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -received at least 1 dose of telavancin since January 1, 2015

    Exclusion Criteria:
    • Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Newland Medical Associates Southfield Michigan United States 48075

    Sponsors and Collaborators

    • Cumberland Pharmaceuticals

    Investigators

    • Study Director: Medical Monitor, Cumberland Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cumberland Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02288234
    Other Study ID Numbers:
    • 0120
    First Posted:
    Nov 11, 2014
    Last Update Posted:
    Jan 15, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Cumberland Pharmaceuticals
    Registry
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Pneumonia
    Pneumonia, Bacterial
    Telavancin

    Study Results

    No Results Posted as of Jan 15, 2019