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Telavancin Observational Use Registry (TOUR) (TOUR)

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.
 
ClinicalTrials.gov Identifier: NCT02288234
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Study Description
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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 Design
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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


Groups and Cohorts
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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
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United States, Michigan
Newland Medical Associates
Southfield, Michigan, United States, 48075
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
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Study Director: Medical Monitor Cumberland Pharmaceuticals, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02288234    
Other Study ID Numbers: 0120
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by Cumberland Pharmaceuticals:
Registry
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Pneumonia
Pneumonia, Bacterial
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
 Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents