Micafungin Versus Liposomal Amphotericin B for Candidaemia and Invasive Candidosis: A Phase III Randomised Double-Blind Trial

Lancet. 2007 May 5;369(9572):1519-1527. doi: 10.1016/S0140-6736(07)60605-9.

Abstract

Background: Invasive candidosis is increasingly prevalent in seriously ill patients. Our aim was to compare micafungin with liposomal amphotericin B for the treatment of adult patients with candidaemia or invasive candidosis.

Methods: We did a double-blind, randomised, multinational non-inferiority study to compare micafungin (100 mg/day) with liposomal amphotericin B (3 mg/kg per day) as first-line treatment of candidaemia and invasive candidosis. The primary endpoint was treatment success, defined as both a clinical and a mycological response at the end of treatment. Primary analyses were done on a per-protocol basis. This trial is registered with ClinicalTrials.gov, number NCT00106288.

Findings: 264 individuals were randomly assigned to treatment with micafungin; 267 were randomly assigned to receive liposomal amphotericin B. 202 individuals in the micafungin group and 190 in the liposomal amphotericin B group were included in the per-protocol analyses. Treatment success was observed for 181 (89.6%) patients treated with micafungin and 170 (89.5%) patients treated with liposomal amphotericin B. The difference in proportions, after stratification by neutropenic status at baseline, was 0.7% (95% CI -5.3 to 6.7). Efficacy was independent of the Candida spp and primary site of infection, as well as neutropenic status, APACHE II score, and whether a catheter was removed or replaced during the study. There were fewer treatment-related adverse events--including those that were serious or led to treatment discontinuation--with micafungin than there were with liposomal amphotericin B.

Interpretation: Micafungin was as effective as--and caused fewer adverse events than--liposomal amphotericin B as first-line treatment of candidaemia and invasive candidosis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • APACHE
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amphotericin B / therapeutic use*
  • Antifungal Agents / therapeutic use*
  • Candidiasis / complications
  • Candidiasis / drug therapy*
  • Candidiasis / microbiology
  • Double-Blind Method
  • Echinocandins
  • Female
  • Humans
  • Lipopeptides
  • Lipoproteins / therapeutic use*
  • Male
  • Micafungin
  • Microbial Sensitivity Tests
  • Middle Aged
  • Peptides, Cyclic / therapeutic use*
  • Treatment Outcome

Substances

  • Antifungal Agents
  • Echinocandins
  • Lipopeptides
  • Lipoproteins
  • Peptides, Cyclic
  • Amphotericin B
  • Micafungin

Associated data

  • ClinicalTrials.gov/NCT00106288