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Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons

BACKGROUND: Oseltamivir has been registered for use as post-exposition prophylaxis (PEP) following exposure to influenza, based on studies among healthy adults. Effectiveness among frail elderly nursing home populations still needs to be properly assessed. METHODS: We conducted a randomised double-b...

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Autores principales: van der Sande, Marianne AB, Meijer, Adam, Şen-Kerpiclik, Fatmagül, Enserink, Remko, Cools, Herman JM, Overduin, Piet, Ferreira, José M, Veldman-Ariessen, Marie-José
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159638/
https://www.ncbi.nlm.nih.gov/pubmed/25210532
http://dx.doi.org/10.1186/1742-7622-11-13
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author van der Sande, Marianne AB
Meijer, Adam
Şen-Kerpiclik, Fatmagül
Enserink, Remko
Cools, Herman JM
Overduin, Piet
Ferreira, José M
Veldman-Ariessen, Marie-José
author_facet van der Sande, Marianne AB
Meijer, Adam
Şen-Kerpiclik, Fatmagül
Enserink, Remko
Cools, Herman JM
Overduin, Piet
Ferreira, José M
Veldman-Ariessen, Marie-José
author_sort van der Sande, Marianne AB
collection PubMed
description BACKGROUND: Oseltamivir has been registered for use as post-exposition prophylaxis (PEP) following exposure to influenza, based on studies among healthy adults. Effectiveness among frail elderly nursing home populations still needs to be properly assessed. METHODS: We conducted a randomised double-blind placebo-controlled trial of PEP with either oseltamivir (75 mg once daily) or placebo among nursing home units where influenza virus was detected; analysis was unblinded. The primary outcome was laboratory-confirmed influenza among residents in units on PEP; the secondary outcome was clinical diagnosis of influenza-like illness (ILI). RESULTS: 42 nursing homes were recruited, in which 17 outbreaks occurred from 2009 through 2013, two caused by influenza virus B, the others caused by influenza virus A(H3N2). Randomisation was successful in 15 outbreaks, with a few chance differences in baseline indicators. Six outbreaks were assigned to oseltamivir and nine to placebo. Influenza virus positive secondary ILI cases were detected in 2/6 and 2/9 units respectively (ns); secondary ILI cases occurred in 2/6 units on oseltamivir, and 5/9 units on placebo (ns). Logistical challenges in ensuring timely administration were considerable. CONCLUSION: We did not find statistical evidence that PEP with oseltamivir given to nursing home residents in routine operational settings exposed to influenza reduced the risk of new influenza infections within a unit nor that of developing ILI. Power however was limited due to far fewer outbreaks in nursing homes than expected since the 2009 pandemic. (RCT nr NL92738)
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spelling pubmed-41596382014-09-11 Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons van der Sande, Marianne AB Meijer, Adam Şen-Kerpiclik, Fatmagül Enserink, Remko Cools, Herman JM Overduin, Piet Ferreira, José M Veldman-Ariessen, Marie-José Emerg Themes Epidemiol Research Article BACKGROUND: Oseltamivir has been registered for use as post-exposition prophylaxis (PEP) following exposure to influenza, based on studies among healthy adults. Effectiveness among frail elderly nursing home populations still needs to be properly assessed. METHODS: We conducted a randomised double-blind placebo-controlled trial of PEP with either oseltamivir (75 mg once daily) or placebo among nursing home units where influenza virus was detected; analysis was unblinded. The primary outcome was laboratory-confirmed influenza among residents in units on PEP; the secondary outcome was clinical diagnosis of influenza-like illness (ILI). RESULTS: 42 nursing homes were recruited, in which 17 outbreaks occurred from 2009 through 2013, two caused by influenza virus B, the others caused by influenza virus A(H3N2). Randomisation was successful in 15 outbreaks, with a few chance differences in baseline indicators. Six outbreaks were assigned to oseltamivir and nine to placebo. Influenza virus positive secondary ILI cases were detected in 2/6 and 2/9 units respectively (ns); secondary ILI cases occurred in 2/6 units on oseltamivir, and 5/9 units on placebo (ns). Logistical challenges in ensuring timely administration were considerable. CONCLUSION: We did not find statistical evidence that PEP with oseltamivir given to nursing home residents in routine operational settings exposed to influenza reduced the risk of new influenza infections within a unit nor that of developing ILI. Power however was limited due to far fewer outbreaks in nursing homes than expected since the 2009 pandemic. (RCT nr NL92738) BioMed Central 2014-09-10 /pmc/articles/PMC4159638/ /pubmed/25210532 http://dx.doi.org/10.1186/1742-7622-11-13 Text en Copyright © 2014 van der Sande et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
van der Sande, Marianne AB
Meijer, Adam
Şen-Kerpiclik, Fatmagül
Enserink, Remko
Cools, Herman JM
Overduin, Piet
Ferreira, José M
Veldman-Ariessen, Marie-José
Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons
title Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons
title_full Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons
title_fullStr Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons
title_full_unstemmed Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons
title_short Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons
title_sort effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159638/
https://www.ncbi.nlm.nih.gov/pubmed/25210532
http://dx.doi.org/10.1186/1742-7622-11-13
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