Cargando…
A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline
BACKGROUND: Eravacycline is a novel fluorocycline approved for treatment of intraabdominal infections, with a broad spectrum of activity against a range of pathogens including multidrug-resistant species, including ESBL- or KPC-producing isolates. It is approved for twice-daily dosing with no need f...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7680490/ https://www.ncbi.nlm.nih.gov/pubmed/33063176 http://dx.doi.org/10.1007/s40121-020-00351-0 |
_version_ | 1783612444940173312 |
---|---|
author | Van Hise, Nicholas Petrak, Russell M. Skorodin, Nathan C. Fliegelman, Robert M. Anderson, Michael Didwania, Vishal Han, Alice Shah, Kairav Chundi, Vishnu Hines, David Roig, Ingrid Kalra, Apoorv |
author_facet | Van Hise, Nicholas Petrak, Russell M. Skorodin, Nathan C. Fliegelman, Robert M. Anderson, Michael Didwania, Vishal Han, Alice Shah, Kairav Chundi, Vishnu Hines, David Roig, Ingrid Kalra, Apoorv |
author_sort | Van Hise, Nicholas |
collection | PubMed |
description | BACKGROUND: Eravacycline is a novel fluorocycline approved for treatment of intraabdominal infections, with a broad spectrum of activity against a range of pathogens including multidrug-resistant species, including ESBL- or KPC-producing isolates. It is approved for twice-daily dosing with no need for adjustment in renal dysfunction. In the concomitant administration with CYP 3A4-inducing drugs, eravacycline dosing should be modified. OBJECTIVE: To evaluate the efficacy and safety of eravacycline in a range of infections such as intraabdominal infections, pneumonia and diabetic foot infections in seriously ill patients. METHODS: A retrospective observational cohort study using electronic patient records of 50 consecutive patients administered eravacycline during inpatient acute care admission or as part of outpatient antibiotic therapy (OPAT). RESULTS: Therapy of 1.5 mg/kg q24h was initiated in the hospital in most patients, although some of the less sick were managed in the office or OPAT setting. All patients concluded their management outside of the hospital. Of the 50 patients, 47 (94%) achieved clinical resolution of their infection and 3 (6%) clinical failures occurred. Only three (6%) patients did not have comorbidities, three had a single comorbidity (6%), and the majority (88%) of patients had two or more comorbidities. Most common infections were intraabdominal (36%), pneumonia (18%), diabetic foot (12%), spontaneous bacterial peritonitis (8%) and empyema (8%). Almost half of infections had more than one pathogen isolated, and resistant isolates were frequent. The drug was well tolerated with only two reports of nausea, which did not result in treatment discontinuation, and in 30 days of post-eravacycline therapy only one case of Clostridiodes difficile. CONCLUSIONS: In this real-world setting, eravacycline demonstrated a similar high level of clinical efficacy as seen in clinical trials, 94%, in a variety of infections, including against multidrug-resistant bacteria, and was well tolerated. |
format | Online Article Text |
id | pubmed-7680490 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-76804902020-11-23 A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline Van Hise, Nicholas Petrak, Russell M. Skorodin, Nathan C. Fliegelman, Robert M. Anderson, Michael Didwania, Vishal Han, Alice Shah, Kairav Chundi, Vishnu Hines, David Roig, Ingrid Kalra, Apoorv Infect Dis Ther Original Research BACKGROUND: Eravacycline is a novel fluorocycline approved for treatment of intraabdominal infections, with a broad spectrum of activity against a range of pathogens including multidrug-resistant species, including ESBL- or KPC-producing isolates. It is approved for twice-daily dosing with no need for adjustment in renal dysfunction. In the concomitant administration with CYP 3A4-inducing drugs, eravacycline dosing should be modified. OBJECTIVE: To evaluate the efficacy and safety of eravacycline in a range of infections such as intraabdominal infections, pneumonia and diabetic foot infections in seriously ill patients. METHODS: A retrospective observational cohort study using electronic patient records of 50 consecutive patients administered eravacycline during inpatient acute care admission or as part of outpatient antibiotic therapy (OPAT). RESULTS: Therapy of 1.5 mg/kg q24h was initiated in the hospital in most patients, although some of the less sick were managed in the office or OPAT setting. All patients concluded their management outside of the hospital. Of the 50 patients, 47 (94%) achieved clinical resolution of their infection and 3 (6%) clinical failures occurred. Only three (6%) patients did not have comorbidities, three had a single comorbidity (6%), and the majority (88%) of patients had two or more comorbidities. Most common infections were intraabdominal (36%), pneumonia (18%), diabetic foot (12%), spontaneous bacterial peritonitis (8%) and empyema (8%). Almost half of infections had more than one pathogen isolated, and resistant isolates were frequent. The drug was well tolerated with only two reports of nausea, which did not result in treatment discontinuation, and in 30 days of post-eravacycline therapy only one case of Clostridiodes difficile. CONCLUSIONS: In this real-world setting, eravacycline demonstrated a similar high level of clinical efficacy as seen in clinical trials, 94%, in a variety of infections, including against multidrug-resistant bacteria, and was well tolerated. Springer Healthcare 2020-10-15 2020-12 /pmc/articles/PMC7680490/ /pubmed/33063176 http://dx.doi.org/10.1007/s40121-020-00351-0 Text en © The Author(s) 2020 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Original Research Van Hise, Nicholas Petrak, Russell M. Skorodin, Nathan C. Fliegelman, Robert M. Anderson, Michael Didwania, Vishal Han, Alice Shah, Kairav Chundi, Vishnu Hines, David Roig, Ingrid Kalra, Apoorv A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline |
title | A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline |
title_full | A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline |
title_fullStr | A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline |
title_full_unstemmed | A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline |
title_short | A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline |
title_sort | real-world assessment of clinical outcomes and safety of eravacycline: a novel fluorocycline |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7680490/ https://www.ncbi.nlm.nih.gov/pubmed/33063176 http://dx.doi.org/10.1007/s40121-020-00351-0 |
work_keys_str_mv | AT vanhisenicholas arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT petrakrussellm arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT skorodinnathanc arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT fliegelmanrobertm arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT andersonmichael arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT didwaniavishal arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT hanalice arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT shahkairav arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT chundivishnu arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT hinesdavid arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT roigingrid arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT kalraapoorv arealworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT vanhisenicholas realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT petrakrussellm realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT skorodinnathanc realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT fliegelmanrobertm realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT andersonmichael realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT didwaniavishal realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT hanalice realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT shahkairav realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT chundivishnu realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT hinesdavid realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT roigingrid realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline AT kalraapoorv realworldassessmentofclinicaloutcomesandsafetyoferavacyclineanovelfluorocycline |