Limited data are available about the safety and efficacy of micafungin in children. A postmarketing surveillance study was conducted to assess the safety and effectiveness of micafungin, an echinocandin antifungal, in pediatric patients. A prospective multicenter postmarketing observational study was carried out between October 2006 and September 2008 in Japan. Pediatric patients under 16 years received an intravenous infusion of micafungin at a dose of 1 mg/kg for candidiasis and 1 to 3 mg/kg for aspergillosis, with the option of increasing the dose if required to 6 mg/kg once daily. All adverse events were recorded. A total of 201 pediatric patients were enrolled. There were 55 adverse drug reactions reported among 42 of 190 patients evaluated for safety (22.1%); the most frequently reported adverse drug reaction was hepatobiliary disorders. No adverse drug reactions were reported in 18 neonates (aged below 4 wk). The overall clinical response rate in 91 patients evaluated for efficacy was 86.8%. The response rate in neonates was 90.0%, and there were no differences in the response rate by age. Micafungin was found to have sufficient safety and effectiveness for the treatment of fungal infections in pediatric patients with various backgrounds.
The original version of this article unfortunately contained several errors.The 6th sentence in the section ''Duration of treatment and mean daily dose of micafungin'' in ''Results'' should read: The percentage of severe mycosis increased with the duration of treatment of micafungin (p \ 0.001) and with the mean daily dose of micafungin (p = 0.014). Patients with severe mycosis comprised 23.0% for B7 treatment days, 20.0% for 8-14 days, 29.2% for 15-28 days, and 28.9% for 29B days. With regard to dose, 21.1% of patients were treated with a mean daily dose of B50 mg, 24.3% with B100 mg, 24.2% with B150 mg, and 32.6% with B300 mg.In Table 3 there are some errors. The correct version of Table 3 is: Table 3 Duration of treatment and mean daily dose of micafungin Item Number of patients (%) Number of patients with severe mycosis (%) Patients analyzed for safety 1,074 (100.0) Duration of treatment (days) B7 266 a (24.8) 61 (23.0) 8-14 416 (38.7) 83 (20.0) 15-28 271 (25.2) 79 (29.2) 29B 121 (11.3) 35 (28.9) Mean ± SD 16.7 ± 17.0 Median (range) 13.0 (1-171) Mean daily dose (mg/day) B50 294 (27.4) 62 (21.1) B100 347 a (32.3) 84 (24.3) B150 347 (32.3) 84 (24.2) B300 86 (8.0) 28 (32.6) Mean ± SD 109.8 ± 55.3 Median (range) 100 (10-300)SD standard deviation a Severity of mycosis was not reported for one patientThe online version of the original article can be found under
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