Telavancin Observational Use Registry (TOUR)

Completed

• Conditions: Hospital Acquired Bacterial Pneumonia; Complicated Skin and Skin Structure Infections; Ventilator Associated Bacterial Pneumonia; Gram Positive Infection
• Interventions: Drug: Vibativ

• Registration Number: NCT02288234
• Lead Sponsor: Cumberland Pharmaceuticals

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.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Primary Completion: 2017-06
• Study Completion: 2017-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1063

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vibativ	Vibativ	This is an observational study for patients who were already prescribed Vibativ.

Primary Outcome Measures

Name	Time	Method
Time to clinical response	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

Name	Time	Method
Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)	30 days

Trial Locations

Locations (1)

Newland Medical Associates; 🇺🇸 Southfield, Michigan, United States