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Telavancin Observational Use Registry (TOUR) (TOUR)

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ClinicalTrials.gov Identifier: NCT02288234
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief 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 who are receiving clinician directed telavancin therapy.

Condition or disease Intervention/treatment
Hospital Acquired Bacterial Pneumonia Complicated Skin and Skin Structure Infections Ventilator Associated Bacterial Pneumonia Gram Positive Infection Drug: 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.

Study Type : Observational
Actual Enrollment : 1063 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Telavancin Observational Use Registry (TOUR)
Actual Study Start Date : November 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Vibativ
This is an observational study for patients who were already prescribed Vibativ.
Drug: Vibativ
This is an observational study for patients who were already prescribed Vibativ.
Other Name: telavancin




Primary Outcome Measures :
  1. 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 :
  1. Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs) [ Time Frame: 30 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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
Investigators
Study Director: Medical Monitor Theravance Biopharma

Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02288234     History of Changes
Other Study ID Numbers: 0120
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Theravance Biopharma:
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