International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia.
Author(s): Ostrosky-Zeichner L, Kontoyiannis D, Raffalli J, Mullane KM, Vazquez J, Anaissie EJ, Lipton J, Jacobs P, van Rensburg JH, Rex JH, Lau W, Facklam D, Buell DN
Affiliation(s): Division of Infectious Diseases, University of Texas Medical School-Houston, 6431 Fannin MSB 2.112, Houston, TX 77030, USA. Luis.Ostrosky-Zeichner@uth.tmc.edu
Publication date & source: 2005-10, Eur J Clin Microbiol Infect Dis., 24(10):654-61.
Publication type: Clinical Trial; Multicenter Study
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.
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