Demographics in Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers

Demographics and Enrollment Data
Study Description
This was a prospective, single-center, open-label, PK and safety study of fluconazole loading dose in infants <2 years of age for the treatment of suspected fungal infections. Subjects were given an intravenous loading dose (25 mg/kg administered over 2 hours via a syringe pump) followed by maintenance therapy (12 mg/kg/d over 1 hour). Study objectives included determining the optimal loading dose and maintenance dose of fluconazole in infants with suspected invasive candidiasis, as well as the safety of these doses in infants. Infants age Age =48 hours and <2 years suspected to have systemic infection and appropriate cultures (blood/urine/cerebrospinal fluid [CSF]) obtained within 72 hours of study entry.