Butters Coen, Grobler Anneke, Rudkin Alannah, Goh Li-Yin, Werdenburg Heather, Hanna Diane, Cole Theresa, Buttery Jim, Thursky Karin, Davidson Andrew, Haeusler Gabrielle M
Department of General Paediatrics and Adolescent Medicine, John Hunter Children's Hospital, Newcastle, Australia.
Infection, Immunity and Global Health, Murdoch Children's Research Institute, Parkville, Australia.
PLoS One. 2024 Dec 9;19(12):e0311523. doi: 10.1371/journal.pone.0311523. eCollection 2024.
In children with cancer, febrile neutropenia (FN) is one of the most common complications of treatment, a leading cause of unplanned and prolonged hospital admission and is the key driver of antibiotic exposure. Co-designed with key stakeholders, 'Early versus Late Stopping of Antibiotics in high-risk FN' (ELSA-FN) is a randomised controlled, non-inferiority trial that compares stopping antibiotics in clinically stable patients after 48 hours with the current standard of care, continuing antibiotics until absolute neutrophil recovery. As an Australian first, we will exploit the potential of electronic medical record (EMR) systems, embedding all key aspects of the trial including screening, consent, randomisation and data collection into standard clinical and EMR workflows. We aim to randomise 320 children with high-risk FN and prospectively collect data on safety, acceptability to clinicians and families, as well as several secondary outcomes related to antibiotic exposure. The findings will contribute to optimal antibiotic use in children with FN internationally and inform design and implementation of future EMR-embedded trials.
在患有癌症的儿童中，发热性中性粒细胞减少症（FN）是治疗中最常见的并发症之一，是计划外和长期住院的主要原因，也是抗生素暴露的主要驱动因素。“高危FN患者抗生素早期停用与晚期停用”（ELSA-FN）试验是与关键利益相关者共同设计的一项随机对照非劣效性试验，该试验将临床稳定患者在48小时后停用抗生素与当前的标准治疗方案（持续使用抗生素直至绝对中性粒细胞恢复）进行比较。作为澳大利亚的首个此类试验，我们将利用电子病历（EMR）系统的潜力，将试验的所有关键方面，包括筛查、同意、随机分组和数据收集，纳入标准临床和EMR工作流程。我们的目标是将320名高危FN儿童随机分组，并前瞻性收集有关安全性、临床医生和家庭的可接受性以及与抗生素暴露相关的几个次要结局的数据。这些研究结果将有助于在国际上优化FN儿童的抗生素使用，并为未来嵌入EMR的试验的设计和实施提供信息。
