Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia.

Abstract

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.

• Authors: M H White, R A Bowden, E S Sandler, M L Graham, G A Noskin, J R Wingard, M Goldman, J A van Burik, A McCabe, J S Lin, M Gurwith, C B Miller
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 27 Issue 2 Pg. 296-302 (Aug 1998) ISSN: 1058-4838 [Print] United States
• PMID: 9709879 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antifungal Agents
• Colloids
• Immunosuppressive Agents
• Amphotericin B
• Cyclosporine
• Tacrolimus

Topics

• Adolescent
• Adult
• Aged
• Amphotericin B (administration & dosage, therapeutic use)
• Antifungal Agents (administration & dosage, therapeutic use)
• Child
• Child, Preschool
• Colloids
• Cyclosporine
• Double-Blind Method
• Female
• Fever (complications, immunology)
• Humans
• Immunosuppressive Agents
• Infant
• Infusions, Intravenous
• Kidney Function Tests
• Male
• Middle Aged
• Mycoses (prevention & control)
• Neutropenia (complications, immunology)
• Opportunistic Infections (prevention & control)
• Pilot Projects
• Prospective Studies
• Tacrolimus
• Treatment Outcome