Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia

David S. Krause, John Reinhardt, Jose A. Vazquez, Annette Reboli, Beth P. Goldstein, Michele Wible, Timothy Henkel

Research output: Contribution to journalArticle

147 Citations (Scopus)

Abstract

This study evaluated the safety and efficacy of anidulafungin, a novel echinocandin, in patients with invasive candidiasis, including candidemia. A total of 123 eligible patients were randomized to one of three intravenous regimens, 50, 75, or 100 mg once daily. Treatment continued for 2 weeks beyond resolution or improvement of signs and symptoms. The primary efficacy criterion was a successful global response rate (i.e., clinical and microbiological success) in the evaluable population at the follow-up (FU) visit, 2 weeks after end of therapy (EOT). One hundred twenty (120) patients received at least one dose of anidulafungin; 68 were evaluable. Review of adverse events and laboratory data indicated no dose response for safety parameters. Non-albicans Candida species accounted for approximately one-half of all isolates. Success rates at EOT were 84, 90, and 89% in the 50-, 75-, and 100-mg groups, respectively. At FU, the success rates were 72, 85, and 83%. Phase 3 studies of anidulafungin for the treatment of invasive candidiasis and candidemia are warranted.

Original languageEnglish (US)
Pages (from-to)2021-2024
Number of pages4
JournalAntimicrobial Agents and Chemotherapy
Volume48
Issue number6
DOIs
StatePublished - Jun 1 2004
Externally publishedYes

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anidulafungin
Invasive Candidiasis
Candidemia
Safety
Echinocandins
Therapeutics
Candida
Signs and Symptoms
Population

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia. / Krause, David S.; Reinhardt, John; Vazquez, Jose A.; Reboli, Annette; Goldstein, Beth P.; Wible, Michele; Henkel, Timothy.

In: Antimicrobial Agents and Chemotherapy, Vol. 48, No. 6, 01.06.2004, p. 2021-2024.

Research output: Contribution to journalArticle

Krause, David S. ; Reinhardt, John ; Vazquez, Jose A. ; Reboli, Annette ; Goldstein, Beth P. ; Wible, Michele ; Henkel, Timothy. / Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia. In: Antimicrobial Agents and Chemotherapy. 2004 ; Vol. 48, No. 6. pp. 2021-2024.
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