Amphotericin B lipid complex in pediatric patients with invasive fungal infections

Background Lipid formulations of amphotericin B have been recently introduc ed for treatment of invasive fungal infections. However, little is known ab out their role in pediatric populations. Methods. We studied the safety and antifungal efficacy of amphotericin B li pid complex (ABLC, Abelcet) in 111 treatment episodes in pediatric patients through an open label, emergency use multicenter study. Patients with inva sive fungal infections were enrolled if they had mycoses refractory to conv entional antifungal therapy, if they were intolerant of previous systemic a ntifungal agents or concomitant nephrotoxic drugs or if they had preexistin g renal disease. Results. All 111 treatment episodes were evaluable for safety and 54 were e valuable for efficacy. The mean serum creatinine for the study population d id not significantly change between baseline (1.23 +/- 0.11 mg/dl) and cess ation of ABLC therapy (1.32 +/- 0.12 mg/dl) during 6 weeks. There were no s ignificant differences observed between initial and end-of-therapy levels o f serum potassium, magnesium, aspartate aminotransferase, alanine aminotran sferase, alkaline phosphatase and hemoglobin. However, there was an increas e in mean total bilirubin (3.66 +/- 0.73 to 5.31 +/- 1.09 mg/dl) at the end of therapy (P = 0.054). Among 54 cases fulfilling criteria for evaluation of antifungal efficacy, a complete or partial therapeutic response was obta ined in 38 patients (70%) after ABLC therapy, Complete or partial therapeut ic response was documented in 56% of cases with aspergillosis (n = 25) and in 81% (n = 27) with candidiasis. Among premature infants (n = 8) and allog eneic marrow recipients (n = 14), response rates were 88 and 57%, respectiv ely. Response was similar in those patients enrolled because of intolerance to previous antifungal therapy or because of progressive infection. Conclusions. These data support the use of ABLC for treatment of invasive f ungal infections in pediatric patients who are intolerant of or refractory to conventional antifungal therapy.