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Pediatr Infect Dis J. 2019 Mar;38(3):275-279. doi: 10.1097/INF.0000000000002237.

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.

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From the Infectious Diseases Unit, 3rd Department of Pediatrics, Faculty of Medicine, Aristotle University School of Health Sciences, Hippokration General Hospital, Thessaloniki, Greece.
Institute of Pediatric Oncology (GRAACC), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
Pfizer Inc., New York, New York.
Pfizer Inc., Beijing, China.
Department of Public Health, Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil.



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.

[Indexed for MEDLINE]

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