Abstract
Background and aim: Invasive fungal infections are a major source of morbidity and mortality in immunocompromized children; however, information on new antifungal therapies in children is limited. We evaluated the efficacy and pharmacokinetics (PK) of micafungin, a novel antifungal agent, by reviewing pediatric data from micafungin clinical trials. Methods: A retrospective review of pediatric data from clinical trials was performed. Results: A total 296 children received micafungin (MICA) for invasive candidiasis (IC), refractory IC, refractory invasive aspergillosis (IA), prophylaxis in hematopoietic stem cell transplantation (HSCT) patients, or to assess PK. Most patients age <1 year were premature (38/66), whereas most children age >1 year were HSCT recipients or malignancy patients (181/230). Median maximum daily dose for patients <1, 1 to 4, 5 to 8, 9 to 12 and 13 to 15 years were 2.0, 1.5, 1.5, 1.9 and 1.5mg/kg, respectively. Treatment success rates are shown in the table. MICA showed linear PK, with a higher clearance in neonates than in older children and adults.
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