AntimicrobiAl reports Background: Invasive fungal infections cause excessive morbidity and

mortality in premature neonates and severely ill infants. Methods: Safety and eff icacy outcomes of micafungin were com-pared between prematurely and non-prematurely born infants <2 years of age. Data were obtained from all completed phase I–III clini-cal trials with micafungin that had enrolled infants (<2 years of age) that were listed in the Astellas Clinical Study Database. Demograph-ics, adverse events, hepatic function tests and treatment success data were extracted and validated by the Astellas biostatistical group for all micafungin-treated patients, <2 years of age, using the unique patient identif ier. Results: One-hundred and sixteen patients included in 9 clinical trials, 48% premature [birth weight (BW) <2500 g and/or gestational age <37 weeks], 52 % non-premature, received ≥1 dose of micafungin. Among premature patients, 14.5 % were low BW (1500–2499 g), 36.4 % very low BW (1000– 1499 g) and 49.1 % extremely low BW (<1000 g). Ninety patients (78%) completed the studies; 13 [11 % (4 premature)] died. Significantly more non-premature than premature patients discontinued treatment (P = 0.003). Treatment-related adverse events were recorded in 23 % of patients with no difference between groups. More extremely low BW (n = 4, 15%) and very low BW (n = 8, 40%) infants experienced treatment-related adverse events than low BW (n = 0) and there was no relation to micafungin dose or duration. For a subgroup of 30 patients with invasive candidiasis, treatment success was achieved in 73 % in both premature and non-premature groups. Prophylaxis was successful in 4/5 non-premature hematopoietic stem cell transplant patients. Conclusion: Micafungin has a safe profile in premature and non-premature infants with substantial efficacy