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.
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
Conditions
MycosesCandidiasis
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Further Details
Primary Outcome Measures:
- Overall response: Resolution of signs and symptoms of infection plus mycological (presumed) eradication
Secondary Outcome Measures:
- Mycological response
- Time to first confirmed negative culture
- All-cause mortality
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.
Study Start
December 2006
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
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.
Total Enrolment
526
Contact Details
Australian Locations:
- Woolloongabba, Australia; Recruiting
- South Brisbane, Australia; Recruiting
- Fremantle, Australia; Recruiting
- South Brisbane, Australia; Recruiting
- Westmead, Australia; Recruiting
- Perth, Australia; Recruiting
Contact the study director; Markus Heep, MD: markus.heep@basilea.com
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