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

Abstract

Background: 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. Methods: Eligible patients with ICC 2 to &lt;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. Results: Forty-nine patients (n = 19, 2 to &lt;5 years; n = 30, 5 to &lt;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. Conclusions: These data support the use of anidulafungin as a treatment option for ICC in children 2 to &lt;18 years old at the studied dose.

Invasive Candidiasis in Infants and Children: Recent Advances in Epidemiology, Diagnosis, and Treatment

“…Building upon earlier preclinical and clinical studies of anidulafungin [42,43], a recently published study reports on the safety and efficacy of anidulafungin in pediatric invasive candidiasis [44]. Anidulafungin was administered at a 3 mg/kg loading dose on day 1 and at a 1.5 mg/kg/d maintenance dose thereafter to patients between the ages of 2 and <18 years.…”

Review on Current Status of Echinocandins Use

“…According to this research, no deaths were reported due to anidulafungin usage, moreover the results were comparable to the reported pharmacokinetic parameters in adults. Another study of anidulafungin application in the treatment of invasive candidiasis in children aged 2 to <18 years also reported this compound as effective and safe in pediatric patients [14].…”

Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis

“…19 The PKs, safety, and efficacy of anidulafungin were evaluated in a recently completed phase IIIb, prospective, open-label, noncomparative study in children aged 1 month to < 18 years of age with confirmed or at high risk of IC (study 1, NCT00761267). 20,21 Here, we describe the PKs of anidulafungin in a pooled population analysis in the first analysis of this type across a full range of ages, from neonates to older adults, in patients with confirmed, suspected, or at high risk of IC. Exposure-response analyses in patients aged from 1 month to older adults with confirmed IC are also reported.…”