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

Research output: Contribution to journalArticle

160 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)654-661
Number of pages8
JournalEuropean Journal of Clinical Microbiology and Infectious Diseases
Volume24
Issue number10
DOIs
StatePublished - Oct 2005
Externally publishedYes

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    Ostrosky-Zeichner, L., Kontoyiannis, D., Raffalli, J., Mullane, K. M., Vazquez, J., Anaissie, E. J., Lipton, J., Jacobs, P., Van Rensburg, J. H. J., Rex, J. H., Lau, W., Facklam, D., & Buell, D. N. (2005). International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia. European Journal of Clinical Microbiology and Infectious Diseases, 24(10), 654-661. https://doi.org/10.1007/s10096-005-0024-8