Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia.
We conducted a prospective, randomized, double-blind study comparing amphotericin B colloidal dispersion (ABCD) with amphotericin B in the empirical treatment of fever and neutropenia. Patients with neutropenia and unresolved fever after > or = 3 days of empirical antibiotic therapy were stratified by age and concomitant use of cyclosporine or tacrolimus. Patients were then randomized to receive therapy with ABCD (4 mg/[kg.d]) or amphotericin B (0.8 mg/[kg.d]) for < or = 14 days. A total of 213 patients were enrolled, of whom 196 were evaluable for efficacy. Fifty percent of ABCD-treated patients and 43.2% of amphotericin B-treated patients had a therapeutic response (P = .31). Renal dysfunction was less likely to develop and occurred later in ABCD recipients than in amphotericin B recipients (P < .001 for both parameters). Infusion-related hypoxia and chills were more common in ABCD recipients than in amphotericin B recipients (P = .013 and P = .018, respectively). ABCD appeared comparable in efficacy with amphotericin B, and renal dysfunction associated with ABCD was significantly less than that associated with amphotericin B. However, infusion-related events were more common with ABCD treatment than with amphotericin B treatment.
White
M H
MH
Infectious Disease Service, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Bowden
R A
RA
Sandler
E S
ES
Graham
M L
ML
Noskin
G A
GA
Wingard
J R
JR
Goldman
M
M
van Burik
J A
JA
McCabe
A
A
Lin
J S
JS
Gurwith
M
M
Miller
C B
CB
D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003102:Colloids; D016572:Cyclosporine; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000150:complications / Q000276:immunology*; D006801:Humans; D007166:Immunosuppressive Agents; D007223:Infant; D007262:Infusions, Intravenous; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000517:prevention & control*; D009503:Neutropenia / Q000150:complications / Q000276:immunology*; D009894:Opportunistic Infections / Q000517:prevention & control*; D010865:Pilot Projects; D011446:Prospective Studies; D016559:Tacrolimus; D016896:Treatment Outcome
D000935:Antifungal Agents; D003102:Colloids; D007166:Immunosuppressive Agents; D000666:Amphotericin B; D016572:Cyclosporine; D016559:Tacrolimus