Use of amphotericin B colloidal dispersion in children

Purpose: To describe the experience with a new lipid-based amphotericin pro duct (amphotericin B colloidal dispersion or ABCD) in children with fever a nd neutropenia who are at high risk for fungal infection. Patients and Methods: Ferry-nine children with febrile neutropenia were tre ated in a prospective, randomized trial comparing ABCD with amphotericin B. An additional 70 children with presumed or proven fungal infection were tr eated with 5 different open-label studies of ABCD. Patients were registered into these studies for reasons of: 1) failure to respond to amphotericin B ; 2) development of nephrotoxicity or preexisting renal impairment; or 3) w illingness to participate in a dose-escalation study. Extensive data detail ing response and toxicity were collected from each patient. Results: In the randomized trial, there was significantly less renal toxici ty in the children receiving ABCD than in those receiving amphotericin B (1 2.0% vs. 52.4% [P = 0.003]). Other adverse symptoms were not significantly different. In the additional open-label studies, although 80% of patients r eceiving ABCD reported some adverse symptom, the majority of these were inf usion related, and nephrotoxicity was reported in only 12% of these patient s. Conclusions: ABCD was well-tolerated at doses up to 5 times greater then th ose usually tolerated with amphotericin B. Renal toxicity was markedly less than expected, and there were no other unexpected severe toxicities. Furth er randomized studies are needed to further define the role of this and oth er liposomal products in children.