Telavancin Observational Use Registry (TOUR)

NCT02288234 | Completed

• 1 other identifier: 0120
• Study Type: observational
• Target: 1,063
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Registry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)

  30 days

Study Arms (1)

Vibativ

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

Drug: Vibativ

Interventions

Vibativ DRUG

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

Also known as: telavancin

Vibativ

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• received at least 1 dose of telavancin since January 1, 2015

You may not qualify if:

• Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

Newland Medical Associates

Southfield, Michigan, 48075, United States

Location

Related Publications (2)

• Sims CR, Bressler AM, Graham DR, Lacy MK, Lombardi DA, Castaneda-Ruiz B. Real-World Clinical Use and Outcomes of Telavancin for the Treatment of Bone and Joint Infections: Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2021 Dec;8(4):509-518. doi: 10.1007/s40801-021-00255-6. Epub 2021 May 26.

  PMID: 34041706 DERIVED

• Reilly J, Jacobs MA, Friedman B, Cleveland KO, Lombardi DA, Castaneda-Ruiz B. Clinical Experience with Telavancin for the Treatment of Patients with Bacteremia and Endocarditis: Real-World Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2020 Sep;7(3):179-189. doi: 10.1007/s40801-020-00191-x.

  PMID: 32372280 DERIVED

MeSH Terms

Interventions

telavancin

Study Officials

• Medical Monitor

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 11, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

US (1)