Hubert Gaelle, Launay Elise, Feildel Fournial Cécile, Chauvire-Drouard Anne, Lorton Fleur, Tavernier Elsa, Giraudeau Bruno, Gras Le Guen Christele
Paediatrics Emergency Department, CHU Nantes, Nantes, France
General Paediatrics Department, CHU Nantes, Nantes, France.
BMJ Open. 2020 Aug 13;10(8):e034828. doi: 10.1136/bmjopen-2019-034828.
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.
发热是儿科急诊科（ED）最常见的就诊原因之一。由于家长和护理人员担心细菌感染，临床医生经常过度开具实验室检查和经验性抗生素治疗。本研究的目的是证明，使用基于降钙素原（PCT）快速检测的预测规则：（1）在发病率和死亡率方面（非劣效性目标）不低于常规治疗；（2）将显著减少抗生素的使用（优效性目标）。
这项前瞻性多中心整群随机研究旨在纳入法国和瑞士26个参与研究的急诊科在24个月期间内7245名6天至3岁发热且无明确病因的儿童。在第一阶段，所有儿童将接受常规护理。在第二阶段，一半的整群将使用基于即时检测PCT的算法。在急诊科就诊后第15天收集的主要终点指标，对于非劣效性目标而言，将是因任何原因死亡或入住重症监护病房的综合结局、特定疾病并发症、急诊科出院后细菌感染的诊断；对于优效性目标而言，将是接受抗生素治疗的儿童比例。将通过使用在中心内参与者聚类和中心内时间段上进行调整的混合逻辑回归模型，对两组（实验组和对照组）的终点指标进行比较。
如果该算法得到验证，将与医学协会讨论一种新的策略，以安全管理幼儿发热，而无需进行微生物检测的侵入性操作或使用经验性抗生素。
本研究于2018年5月17日提交给独立伦理委员会（编号2018 - A00252 - 53）。结果将提交给国际同行评审期刊，并在国际会议上展示。
NCT03607162；预结果。
