A Prospective, Open-label Study to Assess the Safety, Tolerability, and Efficacy of Anidulafungin in the Treatment of Invasive Candidiasis in Children 2 to <18 Years of Age.

BACKGROUND

Treatment with an echinocandin is recommended as first-line therapy for patients with invasive candidiasis including candidemia (ICC). Little is known about the efficacy and safety of anidulafungin in children with ICC.

METHODS

Eligible patients with ICC aged 2-<18 years were enrolled into this prospective, open-label, non-comparative, 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.

RESULTS

Forty-nine patients (n=19, 2-<5 years; n=30, 5-<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 spp. 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 (AE), with diarrhea (22.4%), vomiting (24.5%), and pyrexia (18.4%) being most frequent. Five patients discontinued treatment due to AEs, 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.

CONCLUSIONS

These data support the use of anidulafungin as a treatment option for ICC in children aged 2-<18 years at the studied dose.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.