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Completed

NCT Number: NCT02288234

Telavancin Observational Use Registry (TOUR)

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Newland Medical Associates

Southfield, Michigan, 48075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibativ

Drug

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

Other names: telavancin

Primary outcomes

  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 outcomes

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

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Acronym: TOUR

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2014
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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