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: 17.1Level: LLTClassification code 10060573Term: CandidemiaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2006-003951-18-DE
- Lead Sponsor
- Astellas Global Pharma Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 438
• 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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
• 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 Main Objective: To compare safety and efficacy of treatment with Isavuconazole versus a caspofungin (CAS) ? voriconazole (VRC) regimen in patients with candidemia or other invasive Candida infections;Secondary Objective: To asses safety and tolerability of treatment with ISA versus CAS/voriconazole<br>(VRC) regimen.;Primary end point(s): Overall response at follow-up 1 (FU1) visit (2 weeks after End of Treatment).<br>;Timepoint(s) of evaluation of this end point: Primary Outcome Measures: <br>•Overall response [ Time Frame: 2 weeks after last study dose ] Resolution of signs and symptoms of infection plus mycological (presumed) eradication<br><br><br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Overall response assessment <br>•Mycological response <br>•Clinical response <br>•Time to first confirmed negative culture <br>•All-cause mortality ;Timepoint(s) of evaluation of this end point: •Overall response assessment [ Time Frame: Day 7, end of treatment (up to Day 56), 6 weeks after last study drug ] <br>•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 ] <br>•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 ] <br>•Time to first confirmed negative culture [ Time Frame: Up to 2 weeks after last study drug ] [ Designated as safety issue: No ]<br>•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 ] <br><br>