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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

Page last updated: August 23, 2015

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