Complicated Skin and Skin Structure Infections, Gram Positive Infection, Hospital Acquired Bacterial Pneumonia, Ventilator Associated Bacterial Pneumonia
Conditions
Keywords
Registry
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.
Interventions
DRUGVibativ
This is an observational study for patients who were already prescribed Vibativ.
Sponsors
Cumberland Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs) | 30 days |
Countries
United States
Outcome results
None listed