Date: 01 Nov 2005

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

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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.

Results of this study were partially presented as abstract no. 35 in Focus on Fungal Infection 13, Maui, USA, 2003.
Disclosures pertinent to this study: L.O.Z. has received grant support from and is a speaker and consultant for Astellas Pharma U.S., Inc.; D.P.K. has received research support and honoraria from Merck, Inc., Fujisawa, Inc., Enzon, Inc. and Pfizer, Inc.; J.R. did not indicate any disclosures, J.A.V. has received research support and honoraria from Pfizer, Merck, Vicuron, and Fujisawa; E.J.A. is a consultant, belongs to the speaker’s bureau, and has received research support from Astellas Pharma U.S., Inc.; K.M.M. is a consultant for Enzon Pharmaceuticals; J.L. has been a consultant for Astellas Pharma U.S., Inc.; J.H.R. is an employee of AstraZeneca Pharmaceuticals; W.L., D.F., and D.N.B. are employees of Astellas Pharma U.S., Inc.
An erratum to this article can be found at http://dx.doi.org/10.1007/s10096-005-0069-8