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

Abstract

IntroductionFever 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).Methods and analysisThis 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.DiscussionIf 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.Ethics and disseminationThis 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.Trial registration numberNCT03607162.

A simple clinical decision rule may help to rule out severe bacterial infection and spare antibiotics in febrile young children

“…For these reasons, an external validation needs to be performed, in another patient cohort, before this rule can be considered for clinical use. These preliminary results have been used to design a larger multicentric, prospective and randomised validation study (DIAFEVERCHILD), which is just finished and would confirm or infirm our results 31 …”

“…In a population of young children <5 years consulting for fever without source in the PED, this CDR demonstrates promising diagnostic performance to identify those at low risk for SBI, with specifically good negative predictive value to exclude IBI and would result in a potential reduction of 28.3% of ATB prescriptions. These results should be confirmed by a larger prospective multicentric study before clinical use 31 …”

“…These preliminary results have been used to design a larger multicentric, prospective and randomised validation study (DIAFEVERCHILD), which is just finished and would confirm or infirm our results. 31…”