Use of amphotericin B colloidal dispersion in children.
OBJECTIVE
To describe the experience with a new lipid-based amphotericin product (amphotericin B colloidal dispersion or ABCD) in children with fever and neutropenia who are at high risk for fungal infection.


METHODS
Forty-nine children with febrile neutropenia were treated in a prospective, randomized trial comparing ABCD with amphotericin B. An additional 70 children with presumed or proven fungal infection were treated 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) willingness to participate in a dose-escalation study. Extensive data detailing response and toxicity were collected from each patient.


RESULTS
In the randomized trial, there was significantly less renal toxicity in the children receiving ABCD than in those receiving amphotericin B (12.0% vs. 52.4% [P = 0.003]). Other adverse symptoms were not significantly different. In the additional open-label studies, although 80% of patients receiving ABCD reported some adverse symptom, the majority of these were infusion related, and nephrotoxicity was reported in only 12% of these patients.


CONCLUSIONS
ABCD was well-tolerated at doses up to 5 times greater then those usually tolerated with amphotericin B. Renal toxicity was markedly less than expected, and there were no other unexpected severe toxicities. Further randomized studies are needed to further define the role of this and other liposomal products in children.
Sandler
E S
ES
University of Texas Southwestern Medical Center at Dallas and Children's Medical Center of Dallas, USA.
Mustafa
M M
MM
Tkaczewski
I
I
Graham
M L
ML
Morrison
V A
VA
Green
M
M
Trigg
M
M
Abboud
M
M
Aquino
V M
VM
Gurwith
M
M
Pietrelli
L
L
D000293:Adolescent; D000617:Aminoglycosides; D000666:Amphotericin B / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000009:adverse effects; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004198:Disease Susceptibility; D004347:Drug Interactions; D005260:Female; D005334:Fever / Q000150:complications; D006801:Humans; D016867:Immunocompromised Host; D007166:Immunosuppressive Agents / Q000009:adverse effects; D007674:Kidney Diseases / Q000139:chemically induced / Q000453:epidemiology; D007938:Leukemia / Q000150:complications; D008081:Liposomes; D008297:Male; D009181:Mycoses / Q000209:etiology / Q000517:prevention & control*; D009369:Neoplasms / Q000150:complications; D009503:Neutropenia / Q000150:complications*; D011446:Prospective Studies; D013535:Suspensions
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000935:Antifungal Agents; D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D008081:Liposomes; D013535:Suspensions; D000666:Amphotericin B