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

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