TY - JOUR
T1 - International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia
AU - Ostrosky-Zeichner, L.
AU - Kontoyiannis, D.
AU - Raffalli, J.
AU - Mullane, K. M.
AU - Vazquez, J.
AU - Anaissie, E. J.
AU - Lipton, J.
AU - Jacobs, P.
AU - Van Rensburg, J. H.Jansen
AU - Rex, J. H.
AU - Lau, W.
AU - Facklam, D.
AU - Buell, D. N.
N1 - Funding Information:
Acknowledgements This study was funded by Astellas Pharma U. S., Inc. The authors wish to acknowledge all investigators who contributed to this clinical trial: E. Albano, MD.; E. Anaissie, MD; R. Areyuna, MD; A. Arrieta, MD; J. Blumer, MD, PhD; D. Bodensteiner, MD; A. Brunetto, MD; E. Broun, MD; E. Chavez, MD; C. Cordonnier, MD; A. Cuentas, MD, PhD; M. Della Negra, MD; F. Ravandi, MD, replaced S. Devine, MD.; D. Drennan, MD; P. Flynn, MD; D. Gerstmann, MD; J. Harousseau, MD; J. Hiemenz, MD; C. Jacobs, MD; P. Jacobs, MD; J. Jansen van Rensburg, MD; K. Javaly, MD; M.C. Jordan, MD.; M. Joyce, MD, PhD; D. Kontoyiannis, MD, ScD; R. Krance, MD.; D. Kunimoto, MD; L. Konopka, MD; M. Laverdiere, MD; C. Lemieux, MD; J. Lipton, MD; P. McSweeney, MD, replaced P. Cagnoni, MD; K. Mullane, D. O., Pharm.D, replaced V. Yeldandi, MD, replaced J.P. O’Keefe, MD; J. Mynhardt, MD; N. Novitzky, MD; M. Nucci, MD; L. Ostrosky-Zeichner, MD, replaced J. Rex, MD; G. Palmieri, MD; J. Pasternak, MD; R. Powles, MD; H. Prentice, MD; J. Raffalli, MD; V. Ratanatharathorn, MD; C. Rotstein, MD; I. Salit, MD, replaced J. Conly, MD; S. Sanche, MD; S. Santillana, v; N. Seibel, MD; L. Sender, MD; P. Shalit, MD; H. Silva, MD; J. Stavola, MD, replaced G. Noel, MD; B. Suh, v, PhD; J. Suleiman, MD; J. Tollemar, MD; A. Ullmann, MD; J. van Burik, MD; J. Vazquez, MD; C. Villatoro, MD; C. Viscoli, MD; T. Walsh, MD; and L. Yu, MD.
PY - 2005/10
Y1 - 2005/10
N2 - 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.
AB - 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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U2 - 10.1007/s10096-005-0024-8
DO - 10.1007/s10096-005-0024-8
M3 - Article
C2 - 16261306
AN - SCOPUS:27944466696
VL - 24
SP - 654
EP - 661
JO - European Journal of Clinical Microbiology and Infectious Diseases
JF - European Journal of Clinical Microbiology and Infectious Diseases
SN - 0934-9723
IS - 10
ER -