Telavancin Observational Use Registry (TOUR)

NCT ID: NCT02288234

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1063 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hospital Acquired Bacterial Pneumonia Complicated Skin and Skin Structure Infections Ventilator Associated Bacterial Pneumonia Gram Positive Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Vibativ

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

Vibativ

Intervention Type DRUG

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

Interventions

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Vibativ

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

Intervention Type DRUG

Other Intervention Names

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telavancin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Cumberland Pharmaceuticals, Inc.

Locations

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Newland Medical Associates

Southfield, Michigan, United States

Site Status

Countries

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United States

References

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Sims CR, Bressler AM, Graham DR, Lacy MK, Lombardi DA, Castaneda-Ruiz B. Real-World Clinical Use and Outcomes of Telavancin for the Treatment of Bone and Joint Infections: Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2021 Dec;8(4):509-518. doi: 10.1007/s40801-021-00255-6. Epub 2021 May 26.

Reference Type DERIVED
PMID: 34041706 (View on PubMed)

Reilly J, Jacobs MA, Friedman B, Cleveland KO, Lombardi DA, Castaneda-Ruiz B. Clinical Experience with Telavancin for the Treatment of Patients with Bacteremia and Endocarditis: Real-World Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2020 Sep;7(3):179-189. doi: 10.1007/s40801-020-00191-x.

Reference Type DERIVED
PMID: 32372280 (View on PubMed)

Other Identifiers

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0120

Identifier Type: -

Identifier Source: org_study_id

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