Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial

Introduction Community-acquired pneumonia (CAP) causes around 10 hospitalisations per 1000 child-years, each associated with an average 13 non-routine days experienced and more than 4 parent workdays lost. In adults, steroid treatment shortens time to clinical stabilisation without an increase in co...

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Autores principales: Patrick M Meyer Sauteur, Julia Anna Bielicki, Malte Kohns Vasconcelos, Regina Santoro, Michael Coslovsky, Marco Lurà, Kristina Keitel, Tanja Wachinger, Svetlana Beglinger, Ulrich Heininger, Johannes van den Anker
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Publicado: BMJ Publishing Group 2020
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spelling oai:doaj.org-article:a608ebf78a0f4b2da9a2bee1f5c66b0b2021-11-18T05:30:06ZRandomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial10.1136/bmjopen-2020-0419372044-6055https://doaj.org/article/a608ebf78a0f4b2da9a2bee1f5c66b0b2020-12-01T00:00:00Zhttps://bmjopen.bmj.com/content/10/12/e041937.fullhttps://doaj.org/toc/2044-6055Introduction Community-acquired pneumonia (CAP) causes around 10 hospitalisations per 1000 child-years, each associated with an average 13 non-routine days experienced and more than 4 parent workdays lost. In adults, steroid treatment shortens time to clinical stabilisation without an increase in complications in patients with CAP. However, despite promising data from observational studies, there is a lack of high-quality evidence for the use of steroids.Methods and analysis The KIDS-STEP trial is a multicentre, randomised, double-blind, placebo-controlled superiority trial of betamethasone treatment on outcome of hospitalised children with CAP. Children are enrolled in paediatric emergency departments of hospitals across Switzerland and randomised to adjunct oral betamethasone for 2 days or matching placebo in addition to standard of care treatment. The co-primary outcomes are the proportion of children clinically stable 48 hours after randomisation and the proportion of children with CAP-related readmission within 28 days after randomisation. Secondary outcomes include length of hospital stay, time away from routine childcare and healthcare utilisation and total antibiotic prescriptions within 28 days from randomisation.Each of the co-primary outcomes will be analysed separately. We will test clinical stability rates using a proportion test; to test non-inferiority in readmission rates, we will construct 1−α % CI of the estimated difference and test if it contains the pre-defined margin of 7%. Success is conditional on both tests. A simulation-based sample size estimation determined that recruiting 700 patients will ensure a power of 80% for the study.Ethics and dissemination The trial protocol and materials were approved by ethics committees in Switzerland (lead: Ethikkommission Nordwest und Zentralschweiz) and the regulatory authority Swissmedic. Participants and caregivers provide informed consent prior to study procedures commencing. The trial results will be published in peer-reviewed journals and at national and international conferences. Key messages will also be disseminated via press and social media where appropriate.Trial registration number NCT03474991 and SNCTP000002864.Patrick M Meyer SauteurJulia Anna BielickiMalte Kohns VasconcelosRegina SantoroMichael CoslovskyMarco LuràKristina KeitelTanja WachingerSvetlana BeglingerUlrich HeiningerJohannes van den AnkerBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 10, Iss 12 (2020)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
spellingShingle Medicine
R
Patrick M Meyer Sauteur
Julia Anna Bielicki
Malte Kohns Vasconcelos
Regina Santoro
Michael Coslovsky
Marco Lurà
Kristina Keitel
Tanja Wachinger
Svetlana Beglinger
Ulrich Heininger
Johannes van den Anker
Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial
description Introduction Community-acquired pneumonia (CAP) causes around 10 hospitalisations per 1000 child-years, each associated with an average 13 non-routine days experienced and more than 4 parent workdays lost. In adults, steroid treatment shortens time to clinical stabilisation without an increase in complications in patients with CAP. However, despite promising data from observational studies, there is a lack of high-quality evidence for the use of steroids.Methods and analysis The KIDS-STEP trial is a multicentre, randomised, double-blind, placebo-controlled superiority trial of betamethasone treatment on outcome of hospitalised children with CAP. Children are enrolled in paediatric emergency departments of hospitals across Switzerland and randomised to adjunct oral betamethasone for 2 days or matching placebo in addition to standard of care treatment. The co-primary outcomes are the proportion of children clinically stable 48 hours after randomisation and the proportion of children with CAP-related readmission within 28 days after randomisation. Secondary outcomes include length of hospital stay, time away from routine childcare and healthcare utilisation and total antibiotic prescriptions within 28 days from randomisation.Each of the co-primary outcomes will be analysed separately. We will test clinical stability rates using a proportion test; to test non-inferiority in readmission rates, we will construct 1−α % CI of the estimated difference and test if it contains the pre-defined margin of 7%. Success is conditional on both tests. A simulation-based sample size estimation determined that recruiting 700 patients will ensure a power of 80% for the study.Ethics and dissemination The trial protocol and materials were approved by ethics committees in Switzerland (lead: Ethikkommission Nordwest und Zentralschweiz) and the regulatory authority Swissmedic. Participants and caregivers provide informed consent prior to study procedures commencing. The trial results will be published in peer-reviewed journals and at national and international conferences. Key messages will also be disseminated via press and social media where appropriate.Trial registration number NCT03474991 and SNCTP000002864.
format article
author Patrick M Meyer Sauteur
Julia Anna Bielicki
Malte Kohns Vasconcelos
Regina Santoro
Michael Coslovsky
Marco Lurà
Kristina Keitel
Tanja Wachinger
Svetlana Beglinger
Ulrich Heininger
Johannes van den Anker
author_facet Patrick M Meyer Sauteur
Julia Anna Bielicki
Malte Kohns Vasconcelos
Regina Santoro
Michael Coslovsky
Marco Lurà
Kristina Keitel
Tanja Wachinger
Svetlana Beglinger
Ulrich Heininger
Johannes van den Anker
author_sort Patrick M Meyer Sauteur
title Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial
title_short Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial
title_full Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial
title_fullStr Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial
title_full_unstemmed Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial
title_sort randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the kids-step trial
publisher BMJ Publishing Group
publishDate 2020
url https://doaj.org/article/a608ebf78a0f4b2da9a2bee1f5c66b0b
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