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Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial

INTRODUCTION: Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in intensive care units (ICUs). Using short-course antibiotics to treat VAP caused by Gram-negative non-fermenting bacteria has been reported to be associated with excess pneumonia recurrences. The “REducinG...

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Autores principales: Mo, Yin, West, Timothy Eoin, MacLaren, Graeme, Booraphun, Suchart, Li, Andrew Yunkai, Kayastha, Gyan, Lau, Yie Hui, Chew, Yin Tze, Chetchotisakd, Ploenchan, Tambyah, Paul Anantharajah, Limmathurotsakul, Direk, Cooper, Ben
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8126270/
https://www.ncbi.nlm.nih.gov/pubmed/33986070
http://dx.doi.org/10.1136/bmjopen-2021-050105
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author Mo, Yin
West, Timothy Eoin
MacLaren, Graeme
Booraphun, Suchart
Li, Andrew Yunkai
Kayastha, Gyan
Lau, Yie Hui
Chew, Yin Tze
Chetchotisakd, Ploenchan
Tambyah, Paul Anantharajah
Limmathurotsakul, Direk
Cooper, Ben
author_facet Mo, Yin
West, Timothy Eoin
MacLaren, Graeme
Booraphun, Suchart
Li, Andrew Yunkai
Kayastha, Gyan
Lau, Yie Hui
Chew, Yin Tze
Chetchotisakd, Ploenchan
Tambyah, Paul Anantharajah
Limmathurotsakul, Direk
Cooper, Ben
author_sort Mo, Yin
collection PubMed
description INTRODUCTION: Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in intensive care units (ICUs). Using short-course antibiotics to treat VAP caused by Gram-negative non-fermenting bacteria has been reported to be associated with excess pneumonia recurrences. The “REducinG Antibiotic tReatment Duration for Ventilator-Associated Pneumonia” (REGARD-VAP) trial aims to provide evidence for using a set of reproducible clinical criteria to shorten antibiotic duration for individualised treatment duration of VAP. METHODS AND ANALYSIS: This is a randomised controlled hierarchical non-inferiority–superiority trial being conducted in ICUs across Nepal, Thailand and Singapore. The primary outcome is a composite endpoint of death and pneumonia recurrence at day 60. Secondary outcomes include ventilator-associated events, multidrug-resistant organism infection or colonisation, total duration of antibiotic exposure, mechanical ventilation and hospitalisation. Adult patients who satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria are enrolled. Participants are assessed daily until fever subsides for >48 hours and have stable blood pressure, then randomised to a short duration treatment strategy or a standard-of-care duration arm. Antibiotics may be stopped as early as day 3 if respiratory cultures are negative, and day 5 if respiratory cultures are positive in the short-course arm. Participants receiving standard-of-care will receive antibiotics for at least 8 days. Study participants are followed for 60 days after enrolment. An estimated 460 patients will be required to achieve 80% power to determine non-inferiority with a margin of 12%. All outcomes are compared by absolute risk differences. The conclusion of non-inferiority, and subsequently superiority, will be based on unadjusted and adjusted analyses in both the intention-to-treat and per-protocol populations. ETHICS AND DISSEMINATION: The study has received approvals from the Oxford Tropical Research Ethics Committee and the respective study sites. Results will be disseminated to patients, their caregivers, physicians, the funders, the critical care societies and other researchers. TRIAL REGISTRATION NUMBER: NCT03382548.
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spelling pubmed-81262702021-05-26 Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial Mo, Yin West, Timothy Eoin MacLaren, Graeme Booraphun, Suchart Li, Andrew Yunkai Kayastha, Gyan Lau, Yie Hui Chew, Yin Tze Chetchotisakd, Ploenchan Tambyah, Paul Anantharajah Limmathurotsakul, Direk Cooper, Ben BMJ Open Infectious Diseases INTRODUCTION: Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in intensive care units (ICUs). Using short-course antibiotics to treat VAP caused by Gram-negative non-fermenting bacteria has been reported to be associated with excess pneumonia recurrences. The “REducinG Antibiotic tReatment Duration for Ventilator-Associated Pneumonia” (REGARD-VAP) trial aims to provide evidence for using a set of reproducible clinical criteria to shorten antibiotic duration for individualised treatment duration of VAP. METHODS AND ANALYSIS: This is a randomised controlled hierarchical non-inferiority–superiority trial being conducted in ICUs across Nepal, Thailand and Singapore. The primary outcome is a composite endpoint of death and pneumonia recurrence at day 60. Secondary outcomes include ventilator-associated events, multidrug-resistant organism infection or colonisation, total duration of antibiotic exposure, mechanical ventilation and hospitalisation. Adult patients who satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria are enrolled. Participants are assessed daily until fever subsides for >48 hours and have stable blood pressure, then randomised to a short duration treatment strategy or a standard-of-care duration arm. Antibiotics may be stopped as early as day 3 if respiratory cultures are negative, and day 5 if respiratory cultures are positive in the short-course arm. Participants receiving standard-of-care will receive antibiotics for at least 8 days. Study participants are followed for 60 days after enrolment. An estimated 460 patients will be required to achieve 80% power to determine non-inferiority with a margin of 12%. All outcomes are compared by absolute risk differences. The conclusion of non-inferiority, and subsequently superiority, will be based on unadjusted and adjusted analyses in both the intention-to-treat and per-protocol populations. ETHICS AND DISSEMINATION: The study has received approvals from the Oxford Tropical Research Ethics Committee and the respective study sites. Results will be disseminated to patients, their caregivers, physicians, the funders, the critical care societies and other researchers. TRIAL REGISTRATION NUMBER: NCT03382548. BMJ Publishing Group 2021-05-13 /pmc/articles/PMC8126270/ /pubmed/33986070 http://dx.doi.org/10.1136/bmjopen-2021-050105 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Infectious Diseases
Mo, Yin
West, Timothy Eoin
MacLaren, Graeme
Booraphun, Suchart
Li, Andrew Yunkai
Kayastha, Gyan
Lau, Yie Hui
Chew, Yin Tze
Chetchotisakd, Ploenchan
Tambyah, Paul Anantharajah
Limmathurotsakul, Direk
Cooper, Ben
Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial
title Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial
title_full Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial
title_fullStr Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial
title_full_unstemmed Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial
title_short Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial
title_sort reducing antibiotic treatment duration for ventilator-associated pneumonia (regard-vap): a trial protocol for a randomised clinical trial
topic Infectious Diseases
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8126270/
https://www.ncbi.nlm.nih.gov/pubmed/33986070
http://dx.doi.org/10.1136/bmjopen-2021-050105
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