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

  • L. Ostrosky-Zeichner
  • D. Kontoyiannis
  • J. Raffalli
  • K. M. Mullane
  • J. Vazquez
  • E. J. Anaissie
  • J. Lipton
  • P. Jacobs
  • J. H. Jansen van Rensburg
  • J. H. Rex
  • W. Lau
  • D. Facklam
  • D. N. Buell
Article

DOI: 10.1007/s10096-005-0024-8

Cite this article as:
Ostrosky-Zeichner, L., Kontoyiannis, D., Raffalli, J. et al. Eur J Clin Microbiol Infect Dis (2005) 24: 654. 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.

Copyright information

© Springer-Verlag 2005

Authors and Affiliations

  • L. Ostrosky-Zeichner
    • 1
  • D. Kontoyiannis
    • 2
  • J. Raffalli
    • 3
  • K. M. Mullane
    • 4
  • J. Vazquez
    • 5
  • E. J. Anaissie
    • 6
  • J. Lipton
    • 7
  • P. Jacobs
    • 8
  • J. H. Jansen van Rensburg
    • 9
  • J. H. Rex
    • 1
    • 11
  • W. Lau
    • 10
  • D. Facklam
    • 10
  • D. N. Buell
    • 10
  1. 1.Division of Infectious DiseasesUniversity of Texas Medical School-HoustonHoustonUSA
  2. 2.MD Anderson Cancer CenterHoustonUSA
  3. 3.New York Medical CollegeValhallaUSA
  4. 4.Loyola University Medical CenterMaywoodUSA
  5. 5.Wayne State UniversityDetroitUSA
  6. 6.University of Arkansas for Medical SciencesLittle RockUSA
  7. 7.Princess Margaret HospitalTorontoCanada
  8. 8.Constantiaberg Medi-ClinicPlumsteadSouth Africa
  9. 9.Unitas HospitalLytteltonSouth Africa
  10. 10.Astellas Pharma U.S., Inc. (formerly Fujisawa Healthcare, Inc.)DeerfieldUSA
  11. 11.AstraZeneca PharmaceuticalsMacclesfieldUK

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