Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia Journal Article
| Authors: | White, M. H.; Bowden, R. A.; Sandler, E. S.; Graham, M. L.; Noskin, G. A.; Wingard, J. R.; Goldman, M.; Van Burik, J. A.; McCabe, A.; Lin, J. S.; Gurwith, M.; Miller, C. B. |
| Article Title: | 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 ≤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 ≤ 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. |
| Keywords: | adolescent; adult; child; controlled study; treatment outcome; aged; child, preschool; middle aged; antibiotic therapy; major clinical study; clinical trial; neutropenia; drug efficacy; drug safety; prospective studies; nephrotoxicity; randomized controlled trial; practice guideline; fever; infant; pilot projects; tacrolimus; double blind procedure; double-blind method; infusions, intravenous; cyclosporin; cyclosporine; immunosuppressive agents; intravenous drug administration; opportunistic infections; drug indication; kidney function tests; mycoses; amphotericin b deoxycholate; amphotericin b; antibiotics, antifungal; colloids; amphotericin b cholesterol sulfate; humans; human; male; female; priority journal; article |
| Journal Title: | Clinical Infectious Diseases |
| Volume: | 27 |
| Issue: | 2 |
| ISSN: | 1058-4838 |
| Publisher: | Oxford University Press |
| Date Published: | 1998-08-01 |
| Start Page: | 296 |
| End Page: | 302 |
| Language: | English |
| PUBMED: | 9709879 |
| PROVIDER: | scopus |
| DOI: | 10.1086/514672 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 12 December 2016 -- Source: Scopus |
