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

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European Journal of Clinical Microbiology and Infectious Diseases Aims and scope Submit manuscript

An Erratum to this article was published on 18 January 2006

An Erratum to this article was published on 18 January 2006

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.

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Acknowledgement

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.

Author information

Authors and Affiliations

  1. Division of Infectious Diseases, University of Texas Medical School-Houston, 6431 Fannin MSB 2.112, Houston, TX, 77030, USA

    L. Ostrosky-Zeichner & J. H. Rex

  2. MD Anderson Cancer Center, Houston, TX, USA

    D. Kontoyiannis

  3. New York Medical College, Valhalla, NY, USA

    J. Raffalli

  4. Loyola University Medical Center, Maywood, IL, USA

    K. M. Mullane

  5. Wayne State University, Detroit, MI, USA

    J. Vazquez

  6. University of Arkansas for Medical Sciences, Little Rock, AR, USA

    E. J. Anaissie

  7. Princess Margaret Hospital, Toronto, Canada

    J. Lipton

  8. Constantiaberg Medi-Clinic, Plumstead, South Africa

    P. Jacobs

  9. Unitas Hospital, Lyttelton, South Africa

    J. H. Jansen van Rensburg

  10. Astellas Pharma U.S., Inc. (formerly Fujisawa Healthcare, Inc.), Deerfield, IL, USA

    W. Lau, D. Facklam & D. N. Buell

  11. AstraZeneca Pharmaceuticals, Alderley House, Alderley Park, Macclesfield, UK

    J. H. Rex

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  1. L. Ostrosky-Zeichner
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  2. D. Kontoyiannis
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  6. E. J. Anaissie
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  7. J. Lipton
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  9. J. H. Jansen van Rensburg
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  10. J. H. Rex
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  11. W. Lau
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  12. D. Facklam
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  13. D. N. Buell
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Corresponding author

Correspondence to L. Ostrosky-Zeichner.

Additional information

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

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Ostrosky-Zeichner, L., Kontoyiannis, D., Raffalli, J. et al. International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia. Eur J Clin Microbiol Infect Dis 24, 654–661 (2005). https://doi.org/10.1007/s10096-005-0024-8

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