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

L. Ostrosky-Zeichner, D. Kontoyiannis, J. Raffalli, K. M. Mullane, Jose Antonio Vazquez, E. J. Anaissie, J. Lipton, P. Jacobs, J. H.Jansen Van Rensburg, J. H. Rex, W. Lau, D. Facklam, D. N. Buell

Research output: Contribution to journalArticle

160 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)654-661
Number of pages8
JournalEuropean Journal of Clinical Microbiology and Infectious Diseases
Volume24
Issue number10
DOIs
StatePublished - Jan 1 2005
Externally publishedYes

Fingerprint

Candidemia
Clinical Trials
Candida
Infection
Echinocandins
Therapeutics
Antifungal Agents
Randomized Controlled Trials
micafungin
Pediatrics

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia. / Ostrosky-Zeichner, L.; Kontoyiannis, D.; Raffalli, J.; Mullane, K. M.; Vazquez, Jose Antonio; Anaissie, E. J.; Lipton, J.; Jacobs, P.; Van Rensburg, J. H.Jansen; Rex, J. H.; Lau, W.; Facklam, D.; Buell, D. N.

In: European Journal of Clinical Microbiology and Infectious Diseases, Vol. 24, No. 10, 01.01.2005, p. 654-661.

Research output: Contribution to journalArticle

Ostrosky-Zeichner, L, Kontoyiannis, D, Raffalli, J, Mullane, KM, Vazquez, JA, Anaissie, EJ, Lipton, J, Jacobs, P, Van Rensburg, JHJ, Rex, JH, Lau, W, Facklam, D & Buell, DN 2005, 'International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia', European Journal of Clinical Microbiology and Infectious Diseases, vol. 24, no. 10, pp. 654-661. https://doi.org/10.1007/s10096-005-0024-8
Ostrosky-Zeichner, L. ; Kontoyiannis, D. ; Raffalli, J. ; Mullane, K. M. ; Vazquez, Jose Antonio ; Anaissie, E. J. ; Lipton, J. ; Jacobs, P. ; Van Rensburg, J. H.Jansen ; Rex, J. H. ; Lau, W. ; Facklam, D. ; Buell, D. N. / International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia. In: European Journal of Clinical Microbiology and Infectious Diseases. 2005 ; Vol. 24, No. 10. pp. 654-661.
@article{4f0c6685a46046b58d3e0c025c1d45dd,
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.",
author = "L. Ostrosky-Zeichner and D. Kontoyiannis and J. Raffalli and Mullane, {K. M.} and Vazquez, {Jose Antonio} and Anaissie, {E. J.} and J. Lipton and P. Jacobs and {Van Rensburg}, {J. H.Jansen} and Rex, {J. H.} and W. Lau and D. Facklam and Buell, {D. N.}",
year = "2005",
month = "1",
day = "1",
doi = "10.1007/s10096-005-0024-8",
language = "English (US)",
volume = "24",
pages = "654--661",
journal = "European Journal of Clinical Microbiology and Infectious Diseases",
issn = "0934-9723",
publisher = "Vieweg",
number = "10",

}

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, Jose Antonio

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.

PY - 2005/1/1

Y1 - 2005/1/1

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.

UR - http://www.scopus.com/inward/record.url?scp=27944466696&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=27944466696&partnerID=8YFLogxK

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 -