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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9138055 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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