International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia

Eur J Clin Microbiol Infect Dis. 2005 Oct;24(10):654-61. doi: 10.1007/s10096-005-0024-8.

Abstract

Candida spp. are the fourth leading cause of bloodstream infections, and non-albicans species are increasing in importance. Micafungin is a new echinocandin antifungal agent with excellent in vitro activity against Candida spp. Pediatric, neonatal, and adult patients with new or refractory candidemia were enrolled into this open-label, noncomparative, international study. The initial dose of micafungin was 50 mg/d (1 mg/kg for patients <40 kg) for infections due to C. albicans and 100 mg/d (2 mg/kg for patients <40 kg) for infections due to other species. Dose escalation was allowed. Maximum length of therapy was 42 days. A total of 126 patients were evaluable (received at least five doses of micafungin). Success (complete or partial response) was seen in 83.3% patients overall. Success rates for treatment of infections caused by the most common Candida spp. were as follows: C. albicans 85.1%, C. glabrata 93.8%, C. parapsilosis 86.4%, and C. tropicalis 83.3%. Serious adverse events related to micafungin were uncommon. Micafungin shows promise as a safe and effective agent for the treatment of newly diagnosed and refractory cases of candidemia. Large-scale, randomized, controlled trials are warranted.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Antifungal Agents* / administration & dosage
  • Antifungal Agents* / adverse effects
  • Antifungal Agents* / therapeutic use
  • Candida / classification
  • Candida / drug effects
  • Candidiasis / diagnosis
  • Candidiasis / drug therapy*
  • Candidiasis / microbiology
  • Child
  • Child, Preschool
  • Drug Therapy, Combination
  • Echinocandins
  • Female
  • Fungemia / diagnosis
  • Fungemia / drug therapy*
  • Fungemia / microbiology
  • Humans
  • Infant
  • Infant, Newborn
  • Internationality
  • Lipopeptides
  • Lipoproteins* / administration & dosage
  • Lipoproteins* / adverse effects
  • Lipoproteins* / therapeutic use
  • Male
  • Micafungin
  • Peptides, Cyclic* / administration & dosage
  • Peptides, Cyclic* / adverse effects
  • Peptides, Cyclic* / therapeutic use
  • Prospective Studies
  • Treatment Outcome

Substances

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