The Telavancin Observational Use Registry (TOUR™): Methodology and Preliminary Clinical Experience

Background: Telavancin (TLV) is a lipoglycopeptide antibacterial active against Gram-positive pathogens, including methicillin-sensitive and -resistant Staphylococcus aureus (MSSA and MRSA). Telavancin is administered once-daily, intravenously, and is suitable for both inpatient and outpatient use. There is a need to characterize real-world usage in patients treated with TLV.

Methods: The Telavancin Observational Use Registry (TOUR™) is a multicenter study designed to characterize TLV prescribing patterns in clinical practice. Data are obtained from medical charts through standardized case report forms to characterize infection types, pathogens, and outcomes. Efficacy and safety are assessed for up to 30 days after TLV treatment and clinical success is based on the investigator’s assessment of the medical chart. The TOUR study will obtain data from 50–60 US hospitals and outpatient infusion centers. Patients who received at least 1 dose of TLV are eligible for inclusion. Descriptive analyses will be performed to assess patient demographics, clinical outcomes, and renal adverse events. Results will be stratified by infection type.

Results: At the cutoff date of April 28, 2016, data for 200 patients had been collected from 25 sites. Of these patients, 25% were ≥65 years (median age 55, range 15–92), 54% were male, and 84% were white. The primary infections in these patients included complicated skin and skin structure infection (44%); bone and joint infections (30%); bacteremia (13%); pneumonia (6%); and other types (7%). The predominant pathogens were MRSA (51%), MSSA (15%), and coagulase negative staphylococci (10%). The median TLV dose and duration of treatment were 750 mg (range 100–2000 mg) and 16 days (range 1−299 days), respectively. Positive clinical response (cured or improved to step-down oral therapy) was observed in 74% of patients while 9% of patients failed treatment and 17% were non-evaluable.

Conclusion: The TOUR study has identified TLV usage in bone and joint infections and bacteremia in addition to labeled indications. This study will continue to enroll patients, and will further characterize patterns of TLV usage in the real world, including both inpatient and outpatient settings.