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A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice

The antibiotic dalbavancin is approved for intravenous treatment of adults with acute bacterial skin and skin structure infections. This study aimed to observe the use, effectiveness, and safety of dalbavancin in clinical practice in Germany. It was a multicentre, prospective, and retrospective regi...

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Autores principales: Hanses, Frank, Dolff, Sebastian, Trauth, Janina, Seimetz, Michael, Hagel, Stefan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9138055/
https://www.ncbi.nlm.nih.gov/pubmed/35625206
http://dx.doi.org/10.3390/antibiotics11050563
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author Hanses, Frank
Dolff, Sebastian
Trauth, Janina
Seimetz, Michael
Hagel, Stefan
author_facet Hanses, Frank
Dolff, Sebastian
Trauth, Janina
Seimetz, Michael
Hagel, Stefan
author_sort Hanses, Frank
collection PubMed
description The antibiotic dalbavancin is approved for intravenous treatment of adults with acute bacterial skin and skin structure infections. This study aimed to observe the use, effectiveness, and safety of dalbavancin in clinical practice in Germany. It was a multicentre, prospective, and retrospective registry and consecutively enrolled patients treated with dalbavancin. Each patient was observed from the first to the last dose of dalbavancin, with a 30-day follow-up. Patient inclusion was planned for 2 years, but was terminated early due to low recruitment. All analyses were descriptive. Between November 2018 and December 2019, nine patients were enrolled. Only three patients were treated for the approved indication. Outcome was assessed by the physicians as ‘success’ in five (55.6%) patients, ‘failure’ in one (11.1%) patient, and non-evaluable in three (33.3%) patients. Although the success rate of dalbavancin was lower than reported previously, this may be due to the severity of underlying infections and patients’ high Charlson Comorbidity Index. None of the two reported adverse events were considered related to dalbavancin. These findings were in line with real-world data for dalbavancin from other countries, supporting the drug’s positive benefit–risk profile and suggesting frequent off-label use in German routine practice.
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spelling pubmed-91380552022-05-28 A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice Hanses, Frank Dolff, Sebastian Trauth, Janina Seimetz, Michael Hagel, Stefan Antibiotics (Basel) Article The antibiotic dalbavancin is approved for intravenous treatment of adults with acute bacterial skin and skin structure infections. This study aimed to observe the use, effectiveness, and safety of dalbavancin in clinical practice in Germany. It was a multicentre, prospective, and retrospective registry and consecutively enrolled patients treated with dalbavancin. Each patient was observed from the first to the last dose of dalbavancin, with a 30-day follow-up. Patient inclusion was planned for 2 years, but was terminated early due to low recruitment. All analyses were descriptive. Between November 2018 and December 2019, nine patients were enrolled. Only three patients were treated for the approved indication. Outcome was assessed by the physicians as ‘success’ in five (55.6%) patients, ‘failure’ in one (11.1%) patient, and non-evaluable in three (33.3%) patients. Although the success rate of dalbavancin was lower than reported previously, this may be due to the severity of underlying infections and patients’ high Charlson Comorbidity Index. None of the two reported adverse events were considered related to dalbavancin. These findings were in line with real-world data for dalbavancin from other countries, supporting the drug’s positive benefit–risk profile and suggesting frequent off-label use in German routine practice. MDPI 2022-04-22 /pmc/articles/PMC9138055/ /pubmed/35625206 http://dx.doi.org/10.3390/antibiotics11050563 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Hanses, Frank
Dolff, Sebastian
Trauth, Janina
Seimetz, Michael
Hagel, Stefan
A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice
title A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice
title_full A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice
title_fullStr A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice
title_full_unstemmed A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice
title_short A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice
title_sort multicentre, prospective, and retrospective registry to characterize the use, effectiveness, and safety of dalbavancin in german clinical practice
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9138055/
https://www.ncbi.nlm.nih.gov/pubmed/35625206
http://dx.doi.org/10.3390/antibiotics11050563
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