Treatment with an echinocandin is recommended as first-line therapy for patients with invasive candidiasis
(ICC) including candidemia
. Little is known about the efficacy and safety of anidulafungin
in children with ICC.
Eligible patients with ICC 2 to <18 years old were enrolled into this prospective, open-label, noncomparative, international study (NCT00761267) and received anidulafungin
for 10–35 days (3 mg/kg on day 1, 1.5 mg/kg daily thereafter). Safety was assessed through week 6 follow-up. Efficacy, measured by global response (based on clinical and microbiologic responses), was assessed at end of intravenous treatment (EOIVT), end of treatment, weeks 2 and 6 follow-up.
Forty-nine patients (n = 19, 2 to <5 years; n = 30, 5 to <18 years) received ≥1 dose of anidulafungin
(median 11 days; range 1–35 days) and were assessed for safety. Among 48 patients with a Candida
species isolated, C. albicans
(37.5%), C. parapsilosis
(25.0%), C. tropicalis
(14.6%) and C. lusitaniae
(10.4%) were the most frequent Candida
spp. All patients reported ≥1 treatment-emergent adverse event, with diarrhea (22.4%), vomiting (24.5%) and pyrexia (18.4%) being most frequent. Five patients discontinued treatment because of adverse events, of which 4 discontinuations were considered related to anidulafungin
. All-cause mortality was 8.2% (4/49) by EOIVT and 14.3% (7/49) by week 6 follow-up. None of 7 deaths during the study period were considered treatment related. Global response success rate was 70.8% at EOIVT.
These data support the use of anidulafungin
as a treatment option for ICC in children 2 to <18 years old at the studied dose.