Official Title: “A Phase III, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Isavuconazole Versus Caspofungin Followed by Voriconazole in the Treatment of Candidemia and Other Invasive Candida Infections”

The purpose of the study is to compare the safety and efficacy of Isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral Isavuconazole. Patients are randomized to Isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.

Intervention(s) in this Clinical Trial

• Drug: Isavuconazole
  • Drug treatment
• Drug: Caspofungin followed by Voriconazole
  • Drug treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Isavuconazole
• Active Comparator: 2
  • Caspofungin followed by Voriconazole

Primary Measures

• Overall response: Resolution of signs and symptoms of infection plus mycological (presumed) eradication

Secondary Measures

• Mycological response
• Time to first confirmed negative culture
• All-cause mortality

Inclusion Criteria:

• Patients with systemic candida infection
• Positive blood or deep tissue culture.

Exclusion Criteria:

• Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens.
• Patients with candidemia who failed a previous antifungal therapy for the same infection.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Basilea Pharmaceutica

Overall Clinical Trial Officials and Contacts

Markus Heep, MD Study Director Basilea Pharmaceutica  

Overall Contact: Markus Heep, MD 41-616-061 markus.heep@basilea.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00413218

Study ID Number: WSA-CS-008

ClinicalTrials.gov Identifier: NCT00413218

Health Authority: United States: Food and Drug Administration