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Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study

BACKGROUND: Levonadifloxacin is a novel broad-spectrum antibiotic belonging to the benzoquinolizine subclass of quinolones. It is available in intravenous as well as oral formulation for the treatment of infections caused by common Gram-positive bacterial pathogens including methicillin-resistant St...

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Autores principales: Mehta, Yatin, Sutar, Anand R., Zirpe, Kapil, Kothari, Jay Narendra, Alapati, Chakravarthi, Pathak, Manu, Nagvekar, Vasant C., Mehta, Kapil Dev, Debnath, Khokan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8848560/
https://www.ncbi.nlm.nih.gov/pubmed/35265478
http://dx.doi.org/10.4103/ijabmr.ijabmr_602_21
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author Mehta, Yatin
Sutar, Anand R.
Zirpe, Kapil
Kothari, Jay Narendra
Alapati, Chakravarthi
Pathak, Manu
Nagvekar, Vasant C.
Mehta, Kapil Dev
Debnath, Khokan
author_facet Mehta, Yatin
Sutar, Anand R.
Zirpe, Kapil
Kothari, Jay Narendra
Alapati, Chakravarthi
Pathak, Manu
Nagvekar, Vasant C.
Mehta, Kapil Dev
Debnath, Khokan
author_sort Mehta, Yatin
collection PubMed
description BACKGROUND: Levonadifloxacin is a novel broad-spectrum antibiotic belonging to the benzoquinolizine subclass of quinolones. It is available in intravenous as well as oral formulation for the treatment of infections caused by common Gram-positive bacterial pathogens including methicillin-resistant Staphylococcus aureus (MRSA). PATIENTS AND METHODS: This study retrospectively assessed the real-world safety and efficacy of levonadifloxacin (oral and/or IV) in the treatment of 1229 patients across various clinical conditions. Study outcomes were clinical and microbiological success at the end of therapy. RESULTS: The mean duration of levonadifloxacin therapy was 7.2 days, with a time to clinical improvement averaging at 4 days. Three hundred and three patients received oral therapy, 875 received IV, and 51 received a combination of IV followed by oral therapy. Patients were prescribed levonadifloxacin for skin and soft-tissue infections, diabetic foot infections, septicemia, catheter-related bloodstream infections, bone and joint infections, febrile neutropenia, and respiratory infections including COVID-19 pneumonia. High clinical success rates of 98.3%, 93.7%, and 96.1% with oral, IV, and IV followed by oral levonadifloxacin, respectively, were obtained. Only 11 mild adverse events were reported in 9 patients which included constipation, diarrhea, hyperglycemia, nausea, fatigue, and vomiting. Overall, 96.3% and 97.3% of investigators rated the efficacy and safety of levonadifloxacin as “good to excellent.” CONCLUSIONS: An excellent safety and efficacy profile of levonadifloxacin was observed in this study making it a suitable treatment option for management of various bacterial infections, including those caused by resistant Gram-positive pathogens such as MRSA and quinolone-resistant S. aureus.
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spelling pubmed-88485602022-03-08 Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study Mehta, Yatin Sutar, Anand R. Zirpe, Kapil Kothari, Jay Narendra Alapati, Chakravarthi Pathak, Manu Nagvekar, Vasant C. Mehta, Kapil Dev Debnath, Khokan Int J Appl Basic Med Res Original Article BACKGROUND: Levonadifloxacin is a novel broad-spectrum antibiotic belonging to the benzoquinolizine subclass of quinolones. It is available in intravenous as well as oral formulation for the treatment of infections caused by common Gram-positive bacterial pathogens including methicillin-resistant Staphylococcus aureus (MRSA). PATIENTS AND METHODS: This study retrospectively assessed the real-world safety and efficacy of levonadifloxacin (oral and/or IV) in the treatment of 1229 patients across various clinical conditions. Study outcomes were clinical and microbiological success at the end of therapy. RESULTS: The mean duration of levonadifloxacin therapy was 7.2 days, with a time to clinical improvement averaging at 4 days. Three hundred and three patients received oral therapy, 875 received IV, and 51 received a combination of IV followed by oral therapy. Patients were prescribed levonadifloxacin for skin and soft-tissue infections, diabetic foot infections, septicemia, catheter-related bloodstream infections, bone and joint infections, febrile neutropenia, and respiratory infections including COVID-19 pneumonia. High clinical success rates of 98.3%, 93.7%, and 96.1% with oral, IV, and IV followed by oral levonadifloxacin, respectively, were obtained. Only 11 mild adverse events were reported in 9 patients which included constipation, diarrhea, hyperglycemia, nausea, fatigue, and vomiting. Overall, 96.3% and 97.3% of investigators rated the efficacy and safety of levonadifloxacin as “good to excellent.” CONCLUSIONS: An excellent safety and efficacy profile of levonadifloxacin was observed in this study making it a suitable treatment option for management of various bacterial infections, including those caused by resistant Gram-positive pathogens such as MRSA and quinolone-resistant S. aureus. Wolters Kluwer - Medknow 2022 2022-01-31 /pmc/articles/PMC8848560/ /pubmed/35265478 http://dx.doi.org/10.4103/ijabmr.ijabmr_602_21 Text en Copyright: © 2022 International Journal of Applied and Basic Medical Research https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Original Article
Mehta, Yatin
Sutar, Anand R.
Zirpe, Kapil
Kothari, Jay Narendra
Alapati, Chakravarthi
Pathak, Manu
Nagvekar, Vasant C.
Mehta, Kapil Dev
Debnath, Khokan
Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study
title Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study
title_full Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study
title_fullStr Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study
title_full_unstemmed Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study
title_short Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study
title_sort prescription-event monitoring study on safety and efficacy of levonadifloxacin (oral and i.v.) in management of bacterial infections: findings of real-world observational study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8848560/
https://www.ncbi.nlm.nih.gov/pubmed/35265478
http://dx.doi.org/10.4103/ijabmr.ijabmr_602_21
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