학술논문
Randomised multicentre effectiveness trial of rapid syndromic testing by panel assay in children presenting to European emergency departments with acute respiratory infections—trial protocol for the ADEQUATE Paediatric trial
Document Type
article
Author
Alexander Ross; Andrew Atkinson; Maarten J Postma; Federica Vanoni; Julia A Bielicki; Fernando Antoñanzas; Herman Goossens; Elias Iosifidis; Emmanuel Roilides; Mark Lyttle; Elia Vitale; Malte Kohns Vasconcelos; Florence Allantaz; Claire Hawksworth; Pablo Rojo; Dalia Dawoud; Surbhi Malhotra-Kumar; Silke Peter; Hanna Renk; Marc Bonten; Manuel Gijon; Maggie Nyirenda Nyang’wa; Thea van Asselt; Anthony Hemeson; Cristina Prat Aymerich; Simon van der Pol; Parthena Savvidou; Sophie Vandepitte; Emma Gardiner; Michelle Clements; Yasmine Yau; Giulio Vecchia; Federica D’Ambrosio; Wietske Bouwman; Marjolein van Esschoten; Frank Leus; David de Pooter; Leen Timbermont; Juan Pablo Rodriguez Ruiz; Benjamin Hommel; Marie Tessonneau; Jean-Louis Tissier; Philippe Cleuziat; Pim van Dorst; Paula Rojas; Marino Gonzales; Harry Heijerman; Henri van Werkhoven; Maria Simitsopoulou; Kalliopi Pantzartzi; Kostas Zarras; Argyro Ftergioti; Maria Kitsou; Aristea Karypiadou; Charis Lampada; Konstantina Charisi; Olga Tsiatsiou; Elsa Chorafa; Elisavet Michailidou; Ann-Kathrin Stiegler; Carmen Junk; Kristina Kiesel; Maren Belschner; Maike Seyfried; Kristina Schmauder; Tobias Walter; Dominic Imort; Fabian Behret; Rahel Berger; Leon Pfeiffer; Emanuela Früh; Elena Robinson; Andrea Marten; Claudia Werner; Rosa Calderón; Fátima Machín; Laura Cabello; Andrea Seoane; Sofía Mesa; Lidia Oviedo; Luisa Barón; Irene Hernández; Lisa Capozzi; Louisa Brock; Cecilia Hultin; Louise F Hill; Alessia Severi Conti; Gianluca Gualco
Source
BMJ Open, Vol 14, Iss 4 (2024)
Subject
Language
English
ISSN
2044-6055
Abstract
Introduction Syndromic panel assays, that is, using one test to simultaneously target multiple pathogens with overlapping signs and symptoms, have been integrated into routine paediatric care over the past decade, mainly for more severely ill and hospitalised patients. Their wider availability and short turnaround times open the possibility to apply them to non-hospitalised patients as well. In this context, it is important to trial how clinicians make use of pathogen detection data and if their early availability influences management decisions, particularly antibiotic use and hospitalisation.Methods and analysis Advanced Diagnostics for Enhanced QUality of Antibiotic prescription in respiratory Tract infections in Emergency rooms is an individually randomised, controlled, open-label effectiveness trial comparing the impact of a respiratory pathogen panel assay (BIOFIRE Respiratory Panel 2.1plus) used as a rapid syndromic test on nasopharyngeal swabs in addition to the standard of care versus standard of care alone. The trial will 1:1 randomise 520 participants under the age of 18 at 7 paediatric emergency departments in 5 European countries. Inclusion criteria for the trial consist of two sets, with the first describing respiratory tract infections in paediatric patients and the second describing the situation of potential management uncertainty in which test results may immediately affect management decisions. Enrolment started in July 2021 and is expected to be completed in early 2024. We will perform a two-sample t-test assuming a pooled variance estimate to compare the log-transformed mean time on antibiotic treatment (in hours) and number of days alive out of the hospital within 14 days after study enrolment between the control and intervention arms.Ethics and dissemination The trial protocol and materials were approved by research ethics committees in all participating countries. The respiratory pathogen panel assay is CE marked (assessed to meet European regulations) and FDA (United States Food and Drug Administration) cleared for diagnostic use. 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 NCT04781530.