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Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric controlled, open, cluster-randomised, parallel-group study protocol.

Authors
  • Hubert, Gaelle1
  • Launay, Elise2, 3
  • Feildel Fournial, Cécile4
  • Chauvire-Drouard, Anne3
  • Lorton, Fleur4, 3
  • Tavernier, Elsa5
  • Giraudeau, Bruno5
  • Gras Le Guen, Christele4, 2, 3
  • 1 Paediatrics Emergency Department, CHU Nantes, Nantes, France [email protected] , (France)
  • 2 General Paediatrics Department, CHU Nantes, Nantes, France. , (France)
  • 3 Clinical Research Department, Clinical Investigation Center Femme Enfant Adolescent-1413 INSERM, CHU Nantes, Nantes, France. , (France)
  • 4 Paediatrics Emergency Department, CHU Nantes, Nantes, France. , (France)
  • 5 Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France. , (France)
Type
Published Article
Journal
BMJ Open
Publisher
BMJ
Publication Date
Aug 13, 2020
Volume
10
Issue
8
Identifiers
DOI: 10.1136/bmjopen-2019-034828
PMID: 32792425
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Fever is one of the most common reasons for consultation in the paediatric emergency department (ED). Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment. The aims of this study are to demonstrate that using a procalcitonin (PCT) rapid test-based prediction rule (1) would not be inferior to usual practice in terms of morbidity and mortality (non-inferiority objective) and (2) would result in a significant reduction in antibiotic use (superiority objective). This prospective multicentric cluster-randomised study aims to include 7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period. During first period, all children will receive usual care. In a second period, a point-of-care PCT-based algorithm will be used in half of the clusters. The primary endpoints collected on day 15 after ED consultation will be a composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment administered for the superiority objective. The endpoints will be compared between the two groups (experimental and control) by using a mixed logistic regression model adjusted on clustering of participants within centres and period within centres. If the algorithm is validated, a new strategy will be discussed with medical societies to safely manage fever in young children without the need for invasive procedures for microbiological testing or empirical antibiotics. This study was submitted to an independent ethics committee on 17 May 2018 (no. 2018-A00252-53). Results will be submitted to international peer-reviewed journals and presented at international conferences. NCT03607162; Pre-results. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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