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1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study.
BACKGROUND: outpatient management of low-risk fever and neutropenia should be implemented if close monitoring is accessible and patient compliance is feasible.In this study, we aimed to assess the efficacy and safety of single-agent Levofloxacin versus the Augmentin /ciprofloxacin regimen used in ou...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678580/ http://dx.doi.org/10.1093/ofid/ofad500.1487 |
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author | Khedr, Reham Abdelaziz, Ebtihal mahellawy, hadir Al El-Deen, Nashwa Ezz |
author_facet | Khedr, Reham Abdelaziz, Ebtihal mahellawy, hadir Al El-Deen, Nashwa Ezz |
author_sort | Khedr, Reham |
collection | PubMed |
description | BACKGROUND: outpatient management of low-risk fever and neutropenia should be implemented if close monitoring is accessible and patient compliance is feasible.In this study, we aimed to assess the efficacy and safety of single-agent Levofloxacin versus the Augmentin /ciprofloxacin regimen used in our institute. METHODS: This is a randomized prospective interventional 2 arm study of low-risk febrile neutropenia patients presenting to the emergency department at the National Cancer Institute, Cairo University starting from December 2021 to July 2022. Eligible patients were children< 18 years with Low-risk febrile neutropenia without an aetiological diagnosis.Patients were randomized to double-agent ciprofloxacin and amoxicillin-clavulanic acid in comparison to single-agent levofloxacin. Follow up of the outpatient cases on; Day 1, Day 3, and Day 7 for Resolution of infection and stopping of antibiotics regardless of neutropenia. Drug-related side effects encountered in both arms of the study were reported. A decision analytic model was created to compare the two different treatment strategies Outcome measures were quality-adjusted FN episodes, costs, and incremental cost-effectiveness ratios (ICER). The clinical parameters of the model were derived mainly from data collected at National Cancer Institute. Health effects were expressed in terms of QALY gain.One-way sensitivity analysis (DSA) was conducted. RESULTS: 200 patients (100 in each group) were enrolled. 100% of patients achieved marrow recovery in both arms by D7. Fever subsided in 100% on the Levofloxacin arm compared to 60% in the other group. only 1 patient on the double agent arm was upgraded to HR.Levofloxacin was tolerable in all patients with no significant side effects, while patients in the double agent arm; 4 had diarrhea, 2 nausea, and 2 complained of a bad drug taste. Levofloxacin is the dominant strategy versus Augmentin/ciprofloxacin with incremental QALY 0.0001and lower cost 62.4996 L.E in the treatment of home-based care of febrile neutropenia with a willingness to pay threshold of 77,520 LE per QALY (1 GDP/CAPITA) [Figure: see text] Figure 1 CONCLUSION: Levofloxacin is cost effective and can be administered safely in children with low-risk FN, however close follow-up for long-term side effects and emerging bacterial resistance is warranted. DISCLOSURES: All Authors: No reported disclosures |
format | Online Article Text |
id | pubmed-10678580 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-106785802023-11-27 1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study. Khedr, Reham Abdelaziz, Ebtihal mahellawy, hadir Al El-Deen, Nashwa Ezz Open Forum Infect Dis Abstract BACKGROUND: outpatient management of low-risk fever and neutropenia should be implemented if close monitoring is accessible and patient compliance is feasible.In this study, we aimed to assess the efficacy and safety of single-agent Levofloxacin versus the Augmentin /ciprofloxacin regimen used in our institute. METHODS: This is a randomized prospective interventional 2 arm study of low-risk febrile neutropenia patients presenting to the emergency department at the National Cancer Institute, Cairo University starting from December 2021 to July 2022. Eligible patients were children< 18 years with Low-risk febrile neutropenia without an aetiological diagnosis.Patients were randomized to double-agent ciprofloxacin and amoxicillin-clavulanic acid in comparison to single-agent levofloxacin. Follow up of the outpatient cases on; Day 1, Day 3, and Day 7 for Resolution of infection and stopping of antibiotics regardless of neutropenia. Drug-related side effects encountered in both arms of the study were reported. A decision analytic model was created to compare the two different treatment strategies Outcome measures were quality-adjusted FN episodes, costs, and incremental cost-effectiveness ratios (ICER). The clinical parameters of the model were derived mainly from data collected at National Cancer Institute. Health effects were expressed in terms of QALY gain.One-way sensitivity analysis (DSA) was conducted. RESULTS: 200 patients (100 in each group) were enrolled. 100% of patients achieved marrow recovery in both arms by D7. Fever subsided in 100% on the Levofloxacin arm compared to 60% in the other group. only 1 patient on the double agent arm was upgraded to HR.Levofloxacin was tolerable in all patients with no significant side effects, while patients in the double agent arm; 4 had diarrhea, 2 nausea, and 2 complained of a bad drug taste. Levofloxacin is the dominant strategy versus Augmentin/ciprofloxacin with incremental QALY 0.0001and lower cost 62.4996 L.E in the treatment of home-based care of febrile neutropenia with a willingness to pay threshold of 77,520 LE per QALY (1 GDP/CAPITA) [Figure: see text] Figure 1 CONCLUSION: Levofloxacin is cost effective and can be administered safely in children with low-risk FN, however close follow-up for long-term side effects and emerging bacterial resistance is warranted. DISCLOSURES: All Authors: No reported disclosures Oxford University Press 2023-11-27 /pmc/articles/PMC10678580/ http://dx.doi.org/10.1093/ofid/ofad500.1487 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Abstract Khedr, Reham Abdelaziz, Ebtihal mahellawy, hadir Al El-Deen, Nashwa Ezz 1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study. |
title | 1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study. |
title_full | 1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study. |
title_fullStr | 1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study. |
title_full_unstemmed | 1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study. |
title_short | 1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study. |
title_sort | 1653. cost effectiveness of levofloxacin vs amoxicillin/clavulanate and ciprofloxacin in the outpatient management of low-risk febrile neutropaenia in children with cancer: a randomised control study. |
topic | Abstract |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678580/ http://dx.doi.org/10.1093/ofid/ofad500.1487 |
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