Telavancin Observational Use Registry (TOUR) (TOUR)

January 14, 2019 updated by: Cumberland Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1063

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Newland Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will aim to enroll approximately 1,000 patients from 50-60 hospital sites or outpatient infusion centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to clinical response
Time Frame: 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]
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumberland Pharmaceuticals

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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