Background: Invasive fungal infections cause excessive morbidity and mortality in premature neonates and severely ill infants.
Methods: Safety and efficacy outcomes of micafungin were compared between prematurely and non-prematurely born infants<2-year-old. Data were obtained from all completed phase I-III clinical trials with micafungin that had enrolled infants (<2-year-old) that were listed in the Astellas clinical study database. Demographics, adverse events, hepatic function tests and treatment success data were extracted and validated by the Astellas biostatistical group for all micafungin-treated patients, <2-year-old, using the unique patient identifier.
Results: 116 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; LBW), 36.4% very low BW (1000-1499 g; VLBW), and 49.1% extremely low BW (<1000 g; ELBW). 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 (TRAEs) were recorded in 23% of patients with no difference between groups. More ELBW (n=4, 15%) and VLBW (n=8, 40%) infants experienced TRAEs than LBW (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.
(C) 2014 by Lippincott Williams & Wilkins, Inc.