Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Official Title: “A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 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.

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
  • Drug treatment
• Drug: Voriconazole
  • Drug Treatment

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Overall response
  • Time Frame: 2 weeks after last study dose
    Safety Issue?: No

Secondary Measures

• Overall response assessment
  • Time Frame: Day 7, end of treatment (up to Day 56), 6 weeks after last study drug
    Safety Issue?: No
• Mycological response
  • Time Frame: Day 7, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug
    Safety Issue?: No
• Clinical response
  • Time Frame: Day 7, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug
    Safety Issue?: No
• Time to first confirmed negative culture
  • Time Frame: Up to 2 weeks after last study drug
    Safety Issue?: No
• All-cause mortality
  • Time Frame: Day 14, end of treatment (up to Day 56), 2 weeks after last study drug, 6 weeks after last study drug
    Safety Issue?: No

Inclusion Criteria:

• Patients with candidemia or with an invasive Candida infection
• Presence of fever, hypothermia or other appropriate local sign of infection
• Female patients must be non-lactating and at no risk of pregnancy

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
• Patients previously enrolled in a phase III study with isavuconazole
• Patients with a body weight <40kg

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 Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Astellas Pharma Global Development  

Overall Contact: Astellas Pharma Global Development 800-888-7704 clintrials.info@us.astellas.com

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Study ID Number: 9766-CL-0105

ClinicalTrials.gov Identifier: NCT00413218

Health Authority: United States: Food and Drug Administration