title: International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia.
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.
authors.affiliation: 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
authors.forename: L
authors.initials: L
authors.lastname: Ostrosky-Zeichner
authors.forename: D
authors.initials: D
authors.lastname: Kontoyiannis
authors.forename: J
authors.initials: J
authors.lastname: Raffalli
authors.forename: K M
authors.initials: KM
authors.lastname: Mullane
authors.forename: J
authors.initials: J
authors.lastname: Vazquez
authors.forename: E J
authors.initials: EJ
authors.lastname: Anaissie
authors.forename: J
authors.initials: J
authors.lastname: Lipton
authors.forename: P
authors.initials: P
authors.lastname: Jacobs
authors.forename: J H Jansen
authors.initials: JH
authors.lastname: van Rensburg
authors.forename: J H
authors.initials: JH
authors.lastname: Rex
authors.forename: W
authors.initials: W
authors.lastname: Lau
authors.forename: D
authors.initials: D
authors.lastname: Facklam
authors.forename: D N
authors.initials: DN
authors.lastname: Buell
mesh_terms: D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002175:Candida / Q000145:classification / Q000187:drug effects; D002177:Candidiasis / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D054714:Echinocandins; D005260:Female; D016469:Fungemia / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D038622:Internationality; D055666:Lipopeptides; D008074:Lipoproteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D000077551:Micafungin; D010456:Peptides, Cyclic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; D008074:Lipoproteins; D010456:Peptides, Cyclic; D000077551:Micafungin