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

• Published in: The Pediatric infectious disease journal Vol. 38; no. 3; p. 275
• Main Authors: Roilides, Emmanuel, Carlesse, Fabianne, Leister-Tebbe, Heidi, Conte, Umberto, Yan, Jean L, Liu, Ping, Tawadrous, Margaret, Aram, Jalal A, Queiroz-Telles, Flavio
• Format: Journal Article
• Language: English
• Published: United States 01.03.2019
• Subjects: Administration, Intravenous; Adolescent; Anidulafungin - therapeutic use; Antifungal Agents - therapeutic use; Candida - drug effects; Candidiasis, Invasive - drug therapy; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Internationality; Male; Prospective Studies; Treatment Outcome
• ISSN: 1532-0987
• DOI: 10.1097/INF.0000000000002237

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.