Comparison of effects of amphotericin B deoxycholate infused over 4 or 24 hours: randomised controlled trial

Abstract

Objective: To test the hypothesis that amphotericin B deoxycholate is less toxic when given by continuous infusion than by conventional rapid infusion.

Design: Randomised, controlled, non-blinded, single centre study.

Setting: University hospital providing tertiary clinical care.

Patients: 80 mostly neutropenic patients with refractory fever and suspected or proved invasive fungal infections.

Intervention: Patients were randomised to receive 0.97 mg/kg amphotericin B by continuous infusion over 24 hours or 0.95 mg/kg by rapid infusion over four hours.

Main outcome measures: Patients were evaluated for side effects related to infusion, nephrotoxicity, and mortality up to three months after treatment. Analysis was on an intention to treat basis.

Results: Patients in the continuous infusion group had fewer side effects and significantly reduced nephrotoxicity than those in the rapid infusion group. Overall mortality was higher during treatment and after three months' follow up in the rapid infusion than in the continuous infusion group.

Conclusion: Continuous infusions of amphotericin B reduce nephrotoxicity and side effects related to infusion without increasing mortality.

Figures

Figure 1

Trial profile

Figure 2

Percentage of patients with fever during first days of treatment with amphotericin B

Figure 3

C reactive protein (CRP) concentrations during treatment with amphotericin B compared with baseline levels, expressed as median of ΔCRP (ΔCRP=CRP−CRPbaseline) in mg/l