Telavancin Observational Use Registry (TOUR)
Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hospital Acquired Pneumonia; Complicated Skin and Skin Structure Infections; Ventilator Associated Bacterial Pneumonia
Phase: N/A
Status: Recruiting
Sponsored by: Theravance Biopharma Antibiotics, Inc. Official(s) and/or principal investigator(s): Jon Bruss, Study Director, Affiliation: Theravance Biopharma Antibiotics, Inc.
Overall contact: Jon Bruss, M.D., Phone: 650-808-6000
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 in the U. S. who are receiving clinician
directed telavancin therapy.
Clinical Details
Official title: Telavancin Observational Use Registry (TOUR)
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Time to clinical response
Secondary outcome: Collecting AEs of special interest
Detailed description:
This is a concurrent, 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 in the U. S. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical decision prior to enrollment to initiate treatment with telavancin as part
of routine clinical practice
- Received at least one dose of telavancin, is continuing treatment with telavancin at
the time of enrollment, and has not been treated with telavancin for more than 5 days
prior to enrollment
- Patient and/or legal representative is willing and able to provide informed consent
Exclusion Criteria:
- Concurrent participation in any antibacterial clinical trial
Locations and Contacts
Jon Bruss, M.D., Phone: 650-808-6000
Newland Medical Associates, Southfield, Michigan 48075, United States; Recruiting Vilma Drelickman, MD, Phone: 248-552-0620
Additional Information
Starting date: November 2014
Last updated: April 13, 2015
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