Real-World Clinical Use and Outcomes of Telavancin for the Treatment of Bone and Joint Infections: Results from the Telavancin Observational Use Registry (TOUR™)

Abstract

Background: Additional antibiotic options are needed to treat bone and joint infections caused by penicillin-resistant Gram-positive pathogens.

Objective: This subanalysis of the Telavancin Observational Use Registry (TOUR™) aimed to record real-world telavancin usage patterns in patients with bone and joint infections treated with telavancin.

Methods: TOUR was a multicenter observational-use registry study conducted at 45 US sites between January 2015 and March 2017. Patient characteristics, infection type, infecting pathogen(s), previous treatment, telavancin dosing and duration, clinical response, and adverse event data were collected by retrospective medical chart reviews. As such, inclusion/exclusion criteria were limited, and any patient receiving at least one dose of telavancin at the discretion of the treating physician was eligible. Patients were assessed as either positive clinical response, failed treatment, or indeterminate outcome.

Results: Of the 1063 patients enrolled in TOUR, 27.4% (291/1063) were patients with bone and joint infections including osteomyelitis (with or without prosthetic material), acute septic arthritis, and prosthetic joint infections. Most of these patients had osteomyelitis without prosthetic material (191/291; 66.0%). Among patients assessed at the end of treatment, 211/268 (78.7%) achieved a positive clinical response, 26/268 (9.7%) failed treatment, and 31/268 (11.6%) had an indeterminate outcome. The most frequent pathogen was methicillin-resistant Staphylococcus aureus (110/291; 37.8%). The median (interquartile range [IQR as Q1, Q3]) telavancin dose was 750.0 mg (IQR, 750, 750 mg) or 8.2 mg/kg (IQR, 6.8, 9.7 mg/kg) administered for a median of 26 days (IQR, 12, 42 days). These assessments were recorded in the registry ≥ 30 days after the last dose of telavancin was administered.

Conclusions: Real-world data from the TOUR study show that clinicians are using once-daily telavancin with positive clinical outcomes for the treatment of bone and joint infections caused by Gram-positive pathogens.

Clinical trial registration: This trial was registered with ClinicalTrials.gov (NCT02288234) on 11 November, 2014.

Conflict of interest statement

Charles R. Sims has received research support and speaker honoraria from Theravance Biopharma R&D, Inc. Adam M. Bressler has received fees for participating in advisory boards and speaker bureaus for Theravance Biopharma R&D, Inc. Donald R. Graham has received grants or research support from Apex Bioscience, Aronex, Inc., Arpida, Artisan Pharmaceutical, Astra Zeneca, Aventis, Basilea, Inc., Bayer Corp., Biocryst, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, CEM-102, Centocor, Cerexa, Chiron, Inc., Cubist, Inc., Forest Pharmaceuticals, Genomics, Gilead, GlaxoSmithKline, Incyte Corp., InsMed, Johnson & Johnson, Liposomal Company, Inc., The Medicines Company, Merck & Co., Miles Pharmaceuticals, Novartis Pharmaceuticals, Optimer Pharmaceuticals, Ortho-McNeil, Parke-Davis, Peninsula Pharmaceuticals, Pfizer, Rib-X, Roche Pharmaceuticals, R. W. Johnson, Inc., Salix Pharmaceuticals, Sanofi Pasteur, Schering-Plough, Sequus, Inc., Serono, Targanta, Theravance Biopharma R&D, Inc., Tibotec, Trius Therapeutics, Vertex, and Xoma Corp., and consulting fees from Bristol-Myers Squibb, City of Springfield, Oscient Pharmaceuticals, Memorial Medical Center, Illinois Department of Human Services, Division of Mental Health, Rhone-Poulenc Rorer, Saint John’s Hospital, Sangamon County Department of Public Health, Illinois, Vibra Hospital, Springfield, and various home care programs, nursing homes, and tuberculosis programs. Melinda K. Lacy and David A. Lombardi DL and ML are employees of Theravance Biopharma US, Inc., and may hold stock. Bibiana Castaneda-Ruiz is a former employee of Theravance Biopharma US, Inc., and may hold stock.

© 2021. The Author(s).

Figures

Fig. 1

Clinical outcomes after telavancin treatment of bone and joint infections a overall, b by infection subtype, c by infecting pathogen, and d by baseline creatinine clearance. Positive clinical response includes patients deemed cured or improved to oral step-down therapy. aVancomycin-sensitive Enterococcus faecium (vancomycin minimum inhibitory concentration = 2 µg/mL) with methicillin-resistant Staphylococcus aureus (MRSA) [vancomycin minimum inhibitory concentration = 2 µg/mL] coinfection; Enterobacter cloacae and Citrobacter freundii also detected at baseline. bOne patient assessed at the end of treatment had creatinine clearance (CrCl) < 30 mL/min and had a positive clinical outcome; four patients assessed at the end of treatment were receiving dialysis at baseline, of whom one had a positive clinical response, two experienced treatment failure, and one had an indeterminate outcome. MSSA methicillin-susceptible Staphylococcus aureus