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Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™)

BACKGROUND: Telavancin (TLV) is a lipoglycopeptide antibacterial active against a wide range of Gram-positive pathogens, including methicillin-sensitive and -resistant Staphylococcus aureus (MSSA and MRSA). Bone and joint infections represent a complex set of diseases requiring prolonged antimicrobi...

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Autores principales: Sims, Charles, Bressler, Adam, Lacy, Melinda, Osmukhina, Anna, Castaneda-Ruiz, Bibiana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632217/
http://dx.doi.org/10.1093/ofid/ofx163.052
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author Sims, Charles
Bressler, Adam
Lacy, Melinda
Osmukhina, Anna
Castaneda-Ruiz, Bibiana
author_facet Sims, Charles
Bressler, Adam
Lacy, Melinda
Osmukhina, Anna
Castaneda-Ruiz, Bibiana
author_sort Sims, Charles
collection PubMed
description BACKGROUND: Telavancin (TLV) is a lipoglycopeptide antibacterial active against a wide range of Gram-positive pathogens, including methicillin-sensitive and -resistant Staphylococcus aureus (MSSA and MRSA). Bone and joint infections represent a complex set of diseases requiring prolonged antimicrobial therapy and are commonly caused by Gram-positive pathogens, including S. aureus. METHODS: The Telavancin Observational Use Registry (TOUR™) is a multicenter chart review study designed to characterize infection types, pathogens, and outcomes of patients treated with TLV in clinical practice. Data from TOUR were used to characterize a subset of bone and joint patients. Clinical data including patient demographics, pathogens, outcomes, and adverse events (AEs) were analyzed. Clinical outcomes were determined by investigators’ assessment. RESULTS: As of March 31, 2017, data for more than 1000 patients were collected from 46 sites. Of these, 286 patients were treated for bone and joint infections. Among these 286 patients, median age was 57 years (range 18−92 years) and 27% (n = 76) were aged ≥65 years, 66% (n = 189) were male, and 84% (n = 241) were White. The median body mass index was 30.0 kg/m(2) (range 19.2−62.7 kg/m(2)). MRSA was the most commonly isolated pathogen at baseline (38%; n = 108). The median TLV daily dose and duration of treatment were 750 mg (range 300−1500 mg) or 8.3 mg/kg (range 3.7−16.9 mg/kg) and 26.5 days (range 1−119 days), respectively. Telavancin was used as second-line therapy in 71% (n = 202) of patients, and the majority of patients (66%; n = 189) were treated as outpatients. Overall, 71% (n = 203) of patients were cured or improved to step-down therapy, 9% (n = 25) failed treatment, 10% (n = 30) had an indeterminate clinical outcome at end of therapy (EOT), and 10% (n = 28) had missing or undocumented outcomes. Among the patients who had outcome assessment (n = 258) at EOT, 79% were cured or improved to step-down therapy and 10% failed therapy. AEs were reported in 45 patients; six reported a serious AE, and 32 had AEs leading to TLV discontinuation. CONCLUSION: In a real-world setting, once-daily TLV produced a positive clinical response in >70% of patients with difficult-to-treat bone and joint infections and may represent an alternative treatment option. DISCLOSURES: C. Sims, Theravance Biopharma US, Inc.: Investigator and Speaker’s Bureau, Research grant, Research support and Speaker honorarium. A. Bressler, Theravance Biopharma US, Inc.: Investigator, Scientific Advisor, Shareholder and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium. M. Lacy, Theravance Biopharma US, Inc.: Employee, Salary. A. Osmukhina, Theravance Biopharma US, Inc.: Employee and Shareholder, RSU, Stock Options and Salary. B. Castaneda-Ruiz, Theravance Biopharma US, Inc.: Employee and Shareholder, Salary
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spelling pubmed-56322172017-10-12 Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™) Sims, Charles Bressler, Adam Lacy, Melinda Osmukhina, Anna Castaneda-Ruiz, Bibiana Open Forum Infect Dis Abstracts BACKGROUND: Telavancin (TLV) is a lipoglycopeptide antibacterial active against a wide range of Gram-positive pathogens, including methicillin-sensitive and -resistant Staphylococcus aureus (MSSA and MRSA). Bone and joint infections represent a complex set of diseases requiring prolonged antimicrobial therapy and are commonly caused by Gram-positive pathogens, including S. aureus. METHODS: The Telavancin Observational Use Registry (TOUR™) is a multicenter chart review study designed to characterize infection types, pathogens, and outcomes of patients treated with TLV in clinical practice. Data from TOUR were used to characterize a subset of bone and joint patients. Clinical data including patient demographics, pathogens, outcomes, and adverse events (AEs) were analyzed. Clinical outcomes were determined by investigators’ assessment. RESULTS: As of March 31, 2017, data for more than 1000 patients were collected from 46 sites. Of these, 286 patients were treated for bone and joint infections. Among these 286 patients, median age was 57 years (range 18−92 years) and 27% (n = 76) were aged ≥65 years, 66% (n = 189) were male, and 84% (n = 241) were White. The median body mass index was 30.0 kg/m(2) (range 19.2−62.7 kg/m(2)). MRSA was the most commonly isolated pathogen at baseline (38%; n = 108). The median TLV daily dose and duration of treatment were 750 mg (range 300−1500 mg) or 8.3 mg/kg (range 3.7−16.9 mg/kg) and 26.5 days (range 1−119 days), respectively. Telavancin was used as second-line therapy in 71% (n = 202) of patients, and the majority of patients (66%; n = 189) were treated as outpatients. Overall, 71% (n = 203) of patients were cured or improved to step-down therapy, 9% (n = 25) failed treatment, 10% (n = 30) had an indeterminate clinical outcome at end of therapy (EOT), and 10% (n = 28) had missing or undocumented outcomes. Among the patients who had outcome assessment (n = 258) at EOT, 79% were cured or improved to step-down therapy and 10% failed therapy. AEs were reported in 45 patients; six reported a serious AE, and 32 had AEs leading to TLV discontinuation. CONCLUSION: In a real-world setting, once-daily TLV produced a positive clinical response in >70% of patients with difficult-to-treat bone and joint infections and may represent an alternative treatment option. DISCLOSURES: C. Sims, Theravance Biopharma US, Inc.: Investigator and Speaker’s Bureau, Research grant, Research support and Speaker honorarium. A. Bressler, Theravance Biopharma US, Inc.: Investigator, Scientific Advisor, Shareholder and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium. M. Lacy, Theravance Biopharma US, Inc.: Employee, Salary. A. Osmukhina, Theravance Biopharma US, Inc.: Employee and Shareholder, RSU, Stock Options and Salary. B. Castaneda-Ruiz, Theravance Biopharma US, Inc.: Employee and Shareholder, Salary Oxford University Press 2017-10-04 /pmc/articles/PMC5632217/ http://dx.doi.org/10.1093/ofid/ofx163.052 Text en © The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Abstracts
Sims, Charles
Bressler, Adam
Lacy, Melinda
Osmukhina, Anna
Castaneda-Ruiz, Bibiana
Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™)
title Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™)
title_full Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™)
title_fullStr Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™)
title_full_unstemmed Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™)
title_short Clinical Experience with Telavancin for the Treatment of Patients with Bone and Joint Infections: Preliminary Results from the Telavancin Observational Use Registry (TOUR™)
title_sort clinical experience with telavancin for the treatment of patients with bone and joint infections: preliminary results from the telavancin observational use registry (tour™)
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632217/
http://dx.doi.org/10.1093/ofid/ofx163.052
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