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The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections

BACKGROUND: Oritavancin (ORI) is a long-acting lipoglycopeptide indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible Gram-positive (GP) pathogens. METHODS: Data collected from a retrospective o...

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Autores principales: Redell, Mark, Sierra-Hoffman, Miguel, Assi, Maha, Bochan, Markian, Chansolme, David, Gandhi, Anurag, Sheridan, Kathleen, Soosaipillai, Ivan, Walsh, Thomas, Massey, Jill
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6903788/
https://www.ncbi.nlm.nih.gov/pubmed/31844635
http://dx.doi.org/10.1093/ofid/ofz479
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author Redell, Mark
Sierra-Hoffman, Miguel
Assi, Maha
Bochan, Markian
Chansolme, David
Gandhi, Anurag
Sheridan, Kathleen
Soosaipillai, Ivan
Walsh, Thomas
Massey, Jill
author_facet Redell, Mark
Sierra-Hoffman, Miguel
Assi, Maha
Bochan, Markian
Chansolme, David
Gandhi, Anurag
Sheridan, Kathleen
Soosaipillai, Ivan
Walsh, Thomas
Massey, Jill
author_sort Redell, Mark
collection PubMed
description BACKGROUND: Oritavancin (ORI) is a long-acting lipoglycopeptide indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible Gram-positive (GP) pathogens. METHODS: Data collected from a retrospective observational program (2014–2017), Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME), describe the utilization, outcomes, and adverse events (AEs) associated with ORI in 440 patients treated at 26 US sites for ABSSSI and other GP infections. RESULTS: Clinical success in evaluable patients receiving at least 1 dose of oritavancin was 88.1% (386/438). In a subgroup of patients who received ORI for skin and soft tissue infections (n = 401) and bacteremia (n = 7), clinical success was achieved in 89.0% and 100%, respectively. A cohort of 32 patients received 2–10 ORI doses separated by no more than 14 days for complicated GP infections. Clinical success was observed in 30 of 32 patients (93.8%), including 10 of 11 (90.9%) patients with bone and joint infections and 7 of 8 (87.5%) patients with osteomyelitis. In the safety evaluable population, the overall rate of AEs was 6.6%. CONCLUSIONS: We describe results from a real-world program that includes the largest multicenter, retrospective, observational study in patients who received at least 1 dose of ORI for the treatment of GP infections. This study confirms that ORI is an effective, well-tolerated antibiotic used in single and multiple doses for the treatment of ABSSSIs and complicated GP infections.
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spelling pubmed-69037882019-12-16 The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections Redell, Mark Sierra-Hoffman, Miguel Assi, Maha Bochan, Markian Chansolme, David Gandhi, Anurag Sheridan, Kathleen Soosaipillai, Ivan Walsh, Thomas Massey, Jill Open Forum Infect Dis Major Articles BACKGROUND: Oritavancin (ORI) is a long-acting lipoglycopeptide indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible Gram-positive (GP) pathogens. METHODS: Data collected from a retrospective observational program (2014–2017), Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME), describe the utilization, outcomes, and adverse events (AEs) associated with ORI in 440 patients treated at 26 US sites for ABSSSI and other GP infections. RESULTS: Clinical success in evaluable patients receiving at least 1 dose of oritavancin was 88.1% (386/438). In a subgroup of patients who received ORI for skin and soft tissue infections (n = 401) and bacteremia (n = 7), clinical success was achieved in 89.0% and 100%, respectively. A cohort of 32 patients received 2–10 ORI doses separated by no more than 14 days for complicated GP infections. Clinical success was observed in 30 of 32 patients (93.8%), including 10 of 11 (90.9%) patients with bone and joint infections and 7 of 8 (87.5%) patients with osteomyelitis. In the safety evaluable population, the overall rate of AEs was 6.6%. CONCLUSIONS: We describe results from a real-world program that includes the largest multicenter, retrospective, observational study in patients who received at least 1 dose of ORI for the treatment of GP infections. This study confirms that ORI is an effective, well-tolerated antibiotic used in single and multiple doses for the treatment of ABSSSIs and complicated GP infections. Oxford University Press 2019-11-04 /pmc/articles/PMC6903788/ /pubmed/31844635 http://dx.doi.org/10.1093/ofid/ofz479 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Major Articles
Redell, Mark
Sierra-Hoffman, Miguel
Assi, Maha
Bochan, Markian
Chansolme, David
Gandhi, Anurag
Sheridan, Kathleen
Soosaipillai, Ivan
Walsh, Thomas
Massey, Jill
The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections
title The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections
title_full The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections
title_fullStr The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections
title_full_unstemmed The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections
title_short The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections
title_sort chrome study, a real-world experience of single- and multiple-dose oritavancin for treatment of gram-positive infections
topic Major Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6903788/
https://www.ncbi.nlm.nih.gov/pubmed/31844635
http://dx.doi.org/10.1093/ofid/ofz479
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