Telavancin Observational Use Registry (TOUR) (TOUR)
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ClinicalTrials.gov Identifier: NCT02288234
Recruitment Status :
Active, not recruiting
First Posted : November 11, 2014
Last Update Posted : July 21, 2017
Theravance Biopharma R & D, Inc.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
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.
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.
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]
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study will aim to enroll approximately 1,000 patients from 50-60 hospital sites or outpatient infusion centers.
-received at least 1 dose of telavancin since January 1, 2015
Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015