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Micafungin Versus Liposomal Amphotericin B for Pediatric Patients With Invasive Candidiasis: Substudy of a Randomized Double-Blind Trial.

Author(s): Queiroz-Telles F, Berezin E, Leverger G, Freire A, van der Vyver A, Chotpitayasunondh T, Konja J, Diekmann-Berndt H, Koblinger S, Groll AH, Arrieta A, for the Micafungin Invasive Candidiasis Study Group

Affiliation(s): From the *Hosp de Clinica, Curitiba, daggerSanta Casa de Misericordia, Sao Paulo, Brazil; double daggerHopital d'Enfants Armand Trousseau, Paris, France; section signSanta Casa de Misericordia, Belo Horizonte, Brazil; parallelUniversity of the Free State, Bloemfontein, South Africa; paragraph signQueen Sirikit National Institute of Child Health, Bangkok, Thailand; **Clinical Hospital Centre Zagreb, Zagreb, Croatia, daggerdaggerAstellas Pharma GmbH, Munich, double daggerdouble daggerDepartment of Pediatric Hematology/Oncology, University Children's Hospital, Muenster, Germany, and section sign section signChildren's Hospital, Division of Infectious Disease, Orange, CA.

Publication date & source: 2008-08-01, Pediatr Infect Dis J., [Epub ahead of print]

BACKGROUND:: Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking. METHODS:: We conducted a pediatric substudy as part of a double-blind, randomized, multinational trial to compare micafungin (2 mg/kg) with liposomal amphotericin B (3 mg/kg) as first-line treatment of invasive candidiasis. Treatment success was defined as clinical and mycologic response at the end of therapy. Statistical analyses were descriptive, as the sample size meant that the study was not powered for hypothesis testing. RESULTS:: One hundred six patients were included in the intent-to-treat population; and 98 patients-48 patients in the micafungin group and 50 patients in the liposomal amphotericin B group-in the modified intent-to-treat population. Baseline characteristics were balanced between treatment groups. Overall, 57 patients were <2 years old including 19 patients who were premature at birth; and 41 patients were 2 to <16 years old. Most patients (91/98, 92.9%) had candidemia, and 7/98 (7.1%) patients had other forms of invasive candidiasis. Treatment success was observed for 35/48 (72.9%) patients treated with micafungin and 38/50 (76.0%) patients treated with liposomal amphotericin B. The difference in proportions adjusted for neutropenic status was -2.4% [95% CI: (-20.1 to 15.3)]. Efficacy findings were consistent, independent of the neutropenic status, the age of the patient, and whether the patient was premature at birth. Both treatments were well tolerated, but with a lower incidence of adverse events that led to discontinuation in the micafungin group (2/52, 3.8%) compared with the liposomal amphotericin B group (9/54, 16.7%) (P = 0.05, Fisher exact test). CONCLUSIONS:: Micafungin seems to be similarly effective and as safe as liposomal amphotericin B for the treatment of invasive candidiasis in pediatric patients. (ClinicalTrials.gov number, NCT00106288).

Page last updated: 2008-08-10

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