A phase III, double-blind, randomized study to evaluate the safety and efficacy of BAL8557 versus a Caspofungin followed by Voriconazole regimen in the treatment of candidemia and other invasive Candida infections.
- Conditions
- Treatment of Candidemia and other invasive Candida infectionsMedDRA version: 14.0Level: LLTClassification code 10060573Term: CandidemiaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2006-003951-18-GB
- Lead Sponsor
- Astellas Global Pharma Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 526
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method