A pilot feasibility randomized study with essentially similar design preceded this trial and the results were used for planning the primary trial. ![]() Enrolled patients were followed for re-appearance of fever and rate of re-admission, till the resolution of neutropenia. Randomization was done when the patients became afebrile for at least 24 hours and remained neutropenic standard arm consisted of oral antibiotics, while antibiotics were stopped in the experimental arm. ![]() However, there is lack of robust data for an optimal scientific approach.ĭesign/Methods: In an open label, non-inferiority, randomized controlled phase 3 trial at a tertiary cancer centre in India, patients aged 3-18years, with low risk febrile neutropenia were started on empirical intra-venous antibiotics in outpatient setting. Bakhshi 1ġAIIMS, Department of Medical Oncology, New Delhi, India 2AIIMS, Department of Lab Oncology, New Delhi, India 3AIIMS, Department of Microbiology, New Delhi, Indiaīackground/Objectives: Stratifying pediatric cancer patients with febrile neutropenia into low and high risk groups based on various clinical and laboratory parameters has assisted in de-escalation of antimicrobials in clinics. ![]() ![]() FREE PAPER SESSION (FPS) SIOP Award Session AW01 SIOP19-0929 Early Discontinuation of Antibiotics in Low Risk Pediatric Cancer Patients with Febrile Neutropenia, Before Recovery of Counts: A Phase 3 Randomized Controlled Trial (Dalfen Study)Ī.
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