Protocol for an embedded randomised controlled trial of Early versus Late Stopping of Antibiotics in children with Febrile Neutropenia (ELSA-FN).

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.