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Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol

BACKGROUND: SARS-CoV-2 poses a considerable threat to those living in residential aged care facilities (RACF). RACF COVID-19 outbreaks have been characterised by the rapid spread of infection and high rates of severe disease and associated mortality. Despite a growing body of evidence supporting air...

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Autores principales: Brass, Amanda, Shoubridge, Andrew P., Crotty, Maria, Morawska, Lidia, Bell, Scott C., Qiao, Ming, Woodman, Richard J., Whitehead, Craig, Inacio, Maria C., Miller, Caroline, Corlis, Megan, Larby, Nicolas, Elms, Levi, Sims, Sarah K., Taylor, Steven L., Flynn, Erin, Papanicolas, Lito E., Rogers, Geraint B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8446719/
https://www.ncbi.nlm.nih.gov/pubmed/34535091
http://dx.doi.org/10.1186/s12879-021-06659-7
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author Brass, Amanda
Shoubridge, Andrew P.
Crotty, Maria
Morawska, Lidia
Bell, Scott C.
Qiao, Ming
Woodman, Richard J.
Whitehead, Craig
Inacio, Maria C.
Miller, Caroline
Corlis, Megan
Larby, Nicolas
Elms, Levi
Sims, Sarah K.
Taylor, Steven L.
Flynn, Erin
Papanicolas, Lito E.
Rogers, Geraint B.
author_facet Brass, Amanda
Shoubridge, Andrew P.
Crotty, Maria
Morawska, Lidia
Bell, Scott C.
Qiao, Ming
Woodman, Richard J.
Whitehead, Craig
Inacio, Maria C.
Miller, Caroline
Corlis, Megan
Larby, Nicolas
Elms, Levi
Sims, Sarah K.
Taylor, Steven L.
Flynn, Erin
Papanicolas, Lito E.
Rogers, Geraint B.
author_sort Brass, Amanda
collection PubMed
description BACKGROUND: SARS-CoV-2 poses a considerable threat to those living in residential aged care facilities (RACF). RACF COVID-19 outbreaks have been characterised by the rapid spread of infection and high rates of severe disease and associated mortality. Despite a growing body of evidence supporting airborne transmission of SARS-CoV-2, current infection control measures in RACF including hand hygiene, social distancing, and sterilisation of surfaces, focus on contact and droplet transmission. Germicidal ultraviolet (GUV) light has been used widely to prevent airborne pathogen transmission. Our aim is to investigate the efficacy of GUV technology in reducing the risk of SARS-CoV-2 infection in RACF. METHODS: A multicentre, two-arm double-crossover, randomised controlled trial will be conducted to determine the efficacy of GUV devices to reduce respiratory viral transmission in RACF, as an adjunct to existing infection control measures. The study will be conducted in partnership with three aged care providers in metropolitan and regional South Australia. RACF will be separated into paired within-site zones, then randomised to intervention order (GUV or control). The initial 6-week period will be followed by a 2-week washout before crossover to the second 6-week period. After accounting for estimated within-zone and within-facility correlations of infection, and baseline infection rates (10 per 100 person-days), a sample size of n = 8 zones (n = 40 residents/zone) will provide 89% power to detect a 50% reduction in symptomatic infection rate. The primary outcome will be the incidence rate ratio of combined symptomatic respiratory infections for intervention versus control. Secondary outcomes include incidence rates of hospitalisation for complications associated with respiratory infection; respiratory virus detection in facility air and fomite samples; rates of laboratory confirmed respiratory illnesses and genomic characteristics. DISCUSSION: Measures that can be deployed rapidly into RACF, that avoid the requirement for changes in resident and staff behaviour, and that are effective in reducing the risk of airborne SARS-CoV-2 transmission, would provide considerable benefit in safeguarding a highly vulnerable population. In addition, such measures might substantially reduce rates of other respiratory viruses, which contribute considerably to resident morbidity and mortality. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12621000567820 (registered on 14th May, 2021).
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spelling pubmed-84467192021-09-17 Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol Brass, Amanda Shoubridge, Andrew P. Crotty, Maria Morawska, Lidia Bell, Scott C. Qiao, Ming Woodman, Richard J. Whitehead, Craig Inacio, Maria C. Miller, Caroline Corlis, Megan Larby, Nicolas Elms, Levi Sims, Sarah K. Taylor, Steven L. Flynn, Erin Papanicolas, Lito E. Rogers, Geraint B. BMC Infect Dis Study Protocol BACKGROUND: SARS-CoV-2 poses a considerable threat to those living in residential aged care facilities (RACF). RACF COVID-19 outbreaks have been characterised by the rapid spread of infection and high rates of severe disease and associated mortality. Despite a growing body of evidence supporting airborne transmission of SARS-CoV-2, current infection control measures in RACF including hand hygiene, social distancing, and sterilisation of surfaces, focus on contact and droplet transmission. Germicidal ultraviolet (GUV) light has been used widely to prevent airborne pathogen transmission. Our aim is to investigate the efficacy of GUV technology in reducing the risk of SARS-CoV-2 infection in RACF. METHODS: A multicentre, two-arm double-crossover, randomised controlled trial will be conducted to determine the efficacy of GUV devices to reduce respiratory viral transmission in RACF, as an adjunct to existing infection control measures. The study will be conducted in partnership with three aged care providers in metropolitan and regional South Australia. RACF will be separated into paired within-site zones, then randomised to intervention order (GUV or control). The initial 6-week period will be followed by a 2-week washout before crossover to the second 6-week period. After accounting for estimated within-zone and within-facility correlations of infection, and baseline infection rates (10 per 100 person-days), a sample size of n = 8 zones (n = 40 residents/zone) will provide 89% power to detect a 50% reduction in symptomatic infection rate. The primary outcome will be the incidence rate ratio of combined symptomatic respiratory infections for intervention versus control. Secondary outcomes include incidence rates of hospitalisation for complications associated with respiratory infection; respiratory virus detection in facility air and fomite samples; rates of laboratory confirmed respiratory illnesses and genomic characteristics. DISCUSSION: Measures that can be deployed rapidly into RACF, that avoid the requirement for changes in resident and staff behaviour, and that are effective in reducing the risk of airborne SARS-CoV-2 transmission, would provide considerable benefit in safeguarding a highly vulnerable population. In addition, such measures might substantially reduce rates of other respiratory viruses, which contribute considerably to resident morbidity and mortality. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12621000567820 (registered on 14th May, 2021). BioMed Central 2021-09-17 /pmc/articles/PMC8446719/ /pubmed/34535091 http://dx.doi.org/10.1186/s12879-021-06659-7 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits 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/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Brass, Amanda
Shoubridge, Andrew P.
Crotty, Maria
Morawska, Lidia
Bell, Scott C.
Qiao, Ming
Woodman, Richard J.
Whitehead, Craig
Inacio, Maria C.
Miller, Caroline
Corlis, Megan
Larby, Nicolas
Elms, Levi
Sims, Sarah K.
Taylor, Steven L.
Flynn, Erin
Papanicolas, Lito E.
Rogers, Geraint B.
Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol
title Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol
title_full Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol
title_fullStr Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol
title_full_unstemmed Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol
title_short Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol
title_sort prevention of sars-cov-2 (covid-19) transmission in residential aged care using ultraviolet light (petra): a two-arm crossover randomised controlled trial protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8446719/
https://www.ncbi.nlm.nih.gov/pubmed/34535091
http://dx.doi.org/10.1186/s12879-021-06659-7
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