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Telavancin Observational Use Registry (TOUR) (TOUR)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02288234
First Posted: November 11, 2014
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Telavancin Observational Use Registry (TOUR)

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):

Primary Outcome Measures:
  • 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]


Secondary Outcome Measures:
  • Collecting Renal AEs [ Time Frame: 30 days ]

Estimated Enrollment: 1000
Actual Study Start Date: November 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients receiving Vibativ

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288234


Locations
United States, Michigan
Newland Medical Associates
Southfield, Michigan, United States, 48075
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Bibiana Castaneda, MD Theravance Biopharma R & D, Inc.
  More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02288234     History of Changes
Other Study ID Numbers: 0120
First Submitted: November 5, 2014
First Posted: November 11, 2014
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):
Registry

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents