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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.

Author information

1
From the Infectious Diseases Unit, 3rd Department of Pediatrics, Faculty of Medicine, Aristotle University School of Health Sciences, Hippokration General Hospital, Thessaloniki, Greece.
2
Institute of Pediatric Oncology (GRAACC), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
3
Pfizer Inc., New York, New York.
4
Pfizer Inc., Beijing, China.
5
Department of Public Health, Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil.

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 <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 <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.

CONCLUSIONS:

These data support the use of anidulafungin as a treatment option for ICC in children 2 to <18 years old at the studied dose.

PMID:
30418357
DOI:
10.1097/INF.0000000000002237
[Indexed for MEDLINE]

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