Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis

J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.


Background: Micafungin (FK463) is a new lipopeptide compound (echinocandin) with activity against Aspergillus and Candida species. This study evaluated the safety and efficacy of micafungin in patients with proven or probable invasive aspergillosis (IA).

Methods: A multinational, non-comparative study was conducted to examine proven or probable (pulmonary only) Aspergillus species infection in a wide variety of patient populations. The study employed an open-label design utilizing micafungin alone or in combination with another systemic antifungal agent. Criteria for IA and therapeutic responses were judged by an independent panel.

Results: Of the 331 patients enrolled, only 225 met diagnostic criteria for IA as determined by the independent panel and received at least one dose of micafungin. Patients included 98/225 who had undergone hematopoietic stem cell transplantation (HSCT) (88/98 allogeneic), 48 with graft versus host disease (GVHD), and 83/225 who had received chemotherapy for hematologic malignancy. A favorable response rate at the end of therapy was seen in 35.6% (80/225) of patients. Of those only treated with micafungin, favorable responses were seen in 6/12 (50%) of the primary and 9/22 (40.9%) of the salvage therapy group, with corresponding numbers in the combination treatment groups of 5/17 (29.4%) and 60/174 (34.5%) of the primary and salvage treatment groups, respectively. Of the 326 micafungin-treated patients, 183 (56.1%) died during therapy or in the 6-week follow-up phase; 107 (58.5%) deaths were attributable to IA.

Conclusions: Micafungin as primary or salvage therapy proved efficacious and safe in high-risk patients with IA, although patient numbers are small in the micafungin-only groups.

Publication types

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

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / therapeutic use*
  • Aspergillosis / drug therapy*
  • Child
  • Child, Preschool
  • Drug Therapy, Combination
  • Echinocandins
  • Female
  • Humans
  • Infant
  • Lipopeptides
  • Lipoproteins / administration & dosage
  • Lipoproteins / therapeutic use*
  • Male
  • Micafungin
  • Middle Aged
  • Peptides, Cyclic / administration & dosage
  • Peptides, Cyclic / therapeutic use*


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