Giuseppe
Emeritus
[Source: PLoS ONE, full text: (LINK). Abstract, edited.]
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Treating and Preventing Influenza in Aged Care Facilities: A Cluster Randomised Controlled Trial
Robert Booy<SUP>1</SUP>, Richard I. Lindley<SUP>2</SUP><SUP>*</SUP>, Dominic E. Dwyer<SUP>3</SUP>, Jiehui K. Yin<SUP>1</SUP>, Leon G. Heron<SUP>1</SUP>, Cameron R. M. Moffatt<SUP>1</SUP>, Clayton K. Chiu<SUP>1</SUP>, Alexander E. Rosewell<SUP>1</SUP>, Anna S. Dean<SUP>1</SUP>, Timothy Dobbins<SUP>4</SUP>, David J. Philp<SUP>5</SUP>, Zhanhai Gao<SUP>6</SUP>, C. Raina MacIntyre<SUP>6</SUP>
<SUP></SUP>
1 National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The University of Sydney, Sydney, New South Wales, Australia, 2 Discipline of Medicine, The University of Sydney and The George Institute for Global Health, Sydney, New South Wales, Australia, 3 Centre for Infectious Diseases and Microbiology Laboratory Services, Institute of Clinical Pathology and Medical Research, Westmead Hospital and Sydney Institute for Emerging Infections and Biosecurity, The University of Sydney, Sydney, New South Wales, Australia, 4 Cancer Epidemiology and Services Research, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia, 5 School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia, 6 Faculty of Medicine, School of Public Health and Community Medicine, The University of New South Wales, Sydney, New South Wales, Australia
Abstract
Background
Influenza is an important cause of morbidity and mortality for frail older people. Whilst the antiviral drug oseltamivir (a neuraminidase inhibitor) is approved for treatment and prophylaxis of influenza during outbreaks, there have been no trials comparing treatment only (T) versus treatment and prophylaxis (T&P) in Aged Care Facilities (ACFs). Our objective was to compare a policy of T versus T&P for influenza outbreaks in ACFs.
Methods and Findings
We performed a cluster randomised controlled trial in 16 ACFs, that followed a policy of either ?T??oseltamivir treatment (75 mg twice a day for 5 days)?or ?T&P??treatment and prophylaxis (75 mg once a day for 10 days) for influenza outbreaks over three years, in addition to enhanced surveillance. The primary outcome measure was the attack rate of influenza. Secondary outcomes measures were deaths, hospitalisation, pneumonia and adverse events. Laboratory testing was performed to identify the viral cause of influenza-like illness (ILI) outbreaks. The study period 30 June 2006 to 23 December 2008 included three southern hemisphere winters. During that time, influenza was confirmed as the cause of nine of the 23 ILI outbreaks that occurred amongst the 16 ACFs. The policy of T&P resulted in a significant reduction in the influenza attack rate amongst residents: 93/255 (36%) in residents in T facilities versus 91/397 (23%) in T&P facilities (p = 0.002). We observed a non-significant reduction in staff: 46/216 (21%) in T facilities versus 47/350 (13%) in T&P facilities (p = 0.5). There was a significant reduction in mean duration of outbreaks (T = 24 days, T&P = 11 days, p = 0.04). Deaths, hospitalisations and pneumonia were non-significantly reduced in the T&P allocated facilities. Drug adverse events were common but tolerated.
Conclusion
Our trial lacked power but these results provide some support for a policy of ?treatment and prophylaxis? with oseltamivir in controlling influenza outbreaks in ACFs.
Trail Registration
Australian Clinical Trials Registry ACTRN12606000278538
Citation: Booy R, Lindley RI, Dwyer DE, Yin JK, Heron LG, et al. (2012) Treating and Preventing Influenza in Aged Care Facilities: A Cluster Randomised Controlled Trial. PLoS ONE 7(10): e46509. doi:10.1371/journal.pone.0046509
Editor: D. William Cameron, University of Ottawa, Canada
Received: March 5, 2012; Accepted: August 31, 2012; Published: October 17, 2012
Copyright: ? 2012 Booy et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This work was funded by the Australian Research Council, Linkage Project Scheme LP0668279 with the Moran Health Care Group as partner (http://www.arc.gov.au/). Roche (http://www.roche.com/) provided the oseltamivir and additional funding. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: Richard Lindley has been a paid consultant for CSL in his role of Chairman of Data Monitoring Committees for influenza vaccines. He currently holds the position of Moran Foundation for Older Australians Professor of Geriatric Medicine. The Moran Health Care group were the industrial partners for this study. Robert Booy has received funding from CSL, Roche, Sanofi, GlaxoSmithKline (GSK) and Wyeth to attend and present at scientific meetings; any funding received is directed to a research account at the Children's Hospital at Westmead. Leon Heron has performed consultancy work for Novartis for which payment was made to the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases. He has had travel expenses covered by GSK and Sanofi Pasteur and has conducted sponsored research and investigator-driven research with funding from GSK, Wyeth, Merck, CSL, Roche, and Sanofi Pasteur. David J. Philp's university has received support from GSK and CSL to perform work on pneumococcal transmission and HPV transmission and vaccination and has received payment from CSL for consultancy. The trial was also supported by Roche, but this support does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.
* E-mail: Richard.lindley@sydney.edu.au
-Robert Booy<SUP>1</SUP>, Richard I. Lindley<SUP>2</SUP><SUP>*</SUP>, Dominic E. Dwyer<SUP>3</SUP>, Jiehui K. Yin<SUP>1</SUP>, Leon G. Heron<SUP>1</SUP>, Cameron R. M. Moffatt<SUP>1</SUP>, Clayton K. Chiu<SUP>1</SUP>, Alexander E. Rosewell<SUP>1</SUP>, Anna S. Dean<SUP>1</SUP>, Timothy Dobbins<SUP>4</SUP>, David J. Philp<SUP>5</SUP>, Zhanhai Gao<SUP>6</SUP>, C. Raina MacIntyre<SUP>6</SUP>
<SUP></SUP>
1 National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The University of Sydney, Sydney, New South Wales, Australia, 2 Discipline of Medicine, The University of Sydney and The George Institute for Global Health, Sydney, New South Wales, Australia, 3 Centre for Infectious Diseases and Microbiology Laboratory Services, Institute of Clinical Pathology and Medical Research, Westmead Hospital and Sydney Institute for Emerging Infections and Biosecurity, The University of Sydney, Sydney, New South Wales, Australia, 4 Cancer Epidemiology and Services Research, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia, 5 School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia, 6 Faculty of Medicine, School of Public Health and Community Medicine, The University of New South Wales, Sydney, New South Wales, Australia
Abstract
Background
Influenza is an important cause of morbidity and mortality for frail older people. Whilst the antiviral drug oseltamivir (a neuraminidase inhibitor) is approved for treatment and prophylaxis of influenza during outbreaks, there have been no trials comparing treatment only (T) versus treatment and prophylaxis (T&P) in Aged Care Facilities (ACFs). Our objective was to compare a policy of T versus T&P for influenza outbreaks in ACFs.
Methods and Findings
We performed a cluster randomised controlled trial in 16 ACFs, that followed a policy of either ?T??oseltamivir treatment (75 mg twice a day for 5 days)?or ?T&P??treatment and prophylaxis (75 mg once a day for 10 days) for influenza outbreaks over three years, in addition to enhanced surveillance. The primary outcome measure was the attack rate of influenza. Secondary outcomes measures were deaths, hospitalisation, pneumonia and adverse events. Laboratory testing was performed to identify the viral cause of influenza-like illness (ILI) outbreaks. The study period 30 June 2006 to 23 December 2008 included three southern hemisphere winters. During that time, influenza was confirmed as the cause of nine of the 23 ILI outbreaks that occurred amongst the 16 ACFs. The policy of T&P resulted in a significant reduction in the influenza attack rate amongst residents: 93/255 (36%) in residents in T facilities versus 91/397 (23%) in T&P facilities (p = 0.002). We observed a non-significant reduction in staff: 46/216 (21%) in T facilities versus 47/350 (13%) in T&P facilities (p = 0.5). There was a significant reduction in mean duration of outbreaks (T = 24 days, T&P = 11 days, p = 0.04). Deaths, hospitalisations and pneumonia were non-significantly reduced in the T&P allocated facilities. Drug adverse events were common but tolerated.
Conclusion
Our trial lacked power but these results provide some support for a policy of ?treatment and prophylaxis? with oseltamivir in controlling influenza outbreaks in ACFs.
Trail Registration
Australian Clinical Trials Registry ACTRN12606000278538
Citation: Booy R, Lindley RI, Dwyer DE, Yin JK, Heron LG, et al. (2012) Treating and Preventing Influenza in Aged Care Facilities: A Cluster Randomised Controlled Trial. PLoS ONE 7(10): e46509. doi:10.1371/journal.pone.0046509
Editor: D. William Cameron, University of Ottawa, Canada
Received: March 5, 2012; Accepted: August 31, 2012; Published: October 17, 2012
Copyright: ? 2012 Booy et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This work was funded by the Australian Research Council, Linkage Project Scheme LP0668279 with the Moran Health Care Group as partner (http://www.arc.gov.au/). Roche (http://www.roche.com/) provided the oseltamivir and additional funding. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: Richard Lindley has been a paid consultant for CSL in his role of Chairman of Data Monitoring Committees for influenza vaccines. He currently holds the position of Moran Foundation for Older Australians Professor of Geriatric Medicine. The Moran Health Care group were the industrial partners for this study. Robert Booy has received funding from CSL, Roche, Sanofi, GlaxoSmithKline (GSK) and Wyeth to attend and present at scientific meetings; any funding received is directed to a research account at the Children's Hospital at Westmead. Leon Heron has performed consultancy work for Novartis for which payment was made to the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases. He has had travel expenses covered by GSK and Sanofi Pasteur and has conducted sponsored research and investigator-driven research with funding from GSK, Wyeth, Merck, CSL, Roche, and Sanofi Pasteur. David J. Philp's university has received support from GSK and CSL to perform work on pneumococcal transmission and HPV transmission and vaccination and has received payment from CSL for consultancy. The trial was also supported by Roche, but this support does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.
* E-mail: Richard.lindley@sydney.edu.au
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