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

Antimicrob Agents Chemother. 2004 Jun;48(6):2021-4. doi: 10.1128/AAC.48.6.2021-2024.2004.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • APACHE
  • Adult
  • Aged
  • Aged, 80 and over
  • Anidulafungin
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / adverse effects
  • Antifungal Agents / therapeutic use*
  • Candidiasis / drug therapy*
  • Candidiasis / microbiology
  • Dose-Response Relationship, Drug
  • Echinocandins
  • Female
  • Fungemia / drug therapy*
  • Fungemia / microbiology
  • Humans
  • Male
  • Middle Aged
  • Peptides, Cyclic / administration & dosage
  • Peptides, Cyclic / adverse effects
  • Peptides, Cyclic / therapeutic use*
  • Prospective Studies

Substances

  • Antifungal Agents
  • Echinocandins
  • Peptides, Cyclic
  • Anidulafungin