Telavancin Observational Use Registry (TOUR)

Complicated Skin and Skin Structure Infections Clinical Trial

— TOUR  

Official title:

Telavancin Observational Use Registry (TOUR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288234
• Other study ID #: 0120
• Status: Completed
• Start date: November 2014
• Est. completion date: October 2017

Study information

• Verified date: January 2019
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1063
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Skin and Skin Structure Infections
• Gram Positive Infection
• Hospital Acquired Bacterial Pneumonia
• Infection
• Pneumonia
• Pneumonia, Bacterial
• Ventilator Associated Bacterial Pneumonia

Intervention

Drug:
• Vibativ
This is an observational study for patients who were already prescribed Vibativ.

Locations

Country	Name	City	State
United States	Newland Medical Associates	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical response	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]	6 months
Secondary	Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)		30 days