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Antimicrobial Agents and Chemotherapy, June 2004, p. 2021-2024, Vol. 48, No. 6
0066-4804/04/$08.00+0     DOI: 10.1128/AAC.48.6.2021-2024.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Phase 2, Randomized, Dose-Ranging Study Evaluating the Safety and Efficacy of Anidulafungin in Invasive Candidiasis and Candidemia

David S. Krause,1* John Reinhardt,2 Jose A. Vazquez,3 Annette Reboli,4 Beth P. Goldstein,1 Michele Wible,1 and Timothy Henkel1

Vicuron Pharmaceuticals Inc., King of Prussia, Pennsylvania,1 Christiana Care Health Services, Newark, Delaware,2 Wayne State University School of Medicine, Detroit, Michigan,3 University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School at Camden, Camden, New Jersey4

Received 29 October 2003/ Returned for modification 23 December 2003/ Accepted 9 February 2004

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.

* Corresponding author. Mailing address: Vicuron Pharmaceuticals Inc., 455 S. Gulph Rd., Suite 310, King of Prussia, PA 19406. Phone: (610) 491-2206. Fax: (610) 491-2298. E-mail: dkrause{at}vicuron.com.

Antimicrobial Agents and Chemotherapy, June 2004, p. 2021-2024, Vol. 48, No. 6
0066-4804/04/$08.00+0     DOI: 10.1128/AAC.48.6.2021-2024.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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