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-BE
- 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 who have a positive blood or tissue culture obtained within 96 hours prior to randomization, accompanied by related clinical signs and symptoms or histological or cytological changes. A preliminary positive Gram stain, histology or cytology result of yeast is sufficient for randomization, and final culture results may still be pending at the time of first dose.
-Presence of fever (on one occasion > 38°C oral, or equivalent) or hypothermia (on one occasion < 36°C oral, or equivalent) or hypotension (SBP < 100 mmHg or a decrease in SBP of at least 30 mmHg) or appropriate local signs within 96 hours prior to randomization.
-Subject agrees to not participate in any other clinical trial with another investigational drug.
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
-Patients at high risk for QT/QTc prolongation
-Concomitant use of sirolimus, everolimus, efavirenz, ritonavir, astemizole, cisapride, rifampicin/rifampin, rifabutin, ergot alkaloids, long acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine, ketoconazole, valproic acid, St. John’s Wort, or terfenadine in the 5 days prior to first administration of study medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of treatment with isavuconazole (ISA) versus caspofungin (CAS) in patients with candidemia or other invasive Candida infections.;Secondary Objective: To asses safety and tolerability of treatment with ISA versus CAS/voriconazole (VRC) regimen.;Primary end point(s): Overall response at the end of IV therapy (i.e. caspofungin or isavuconazole) as determined by the independent blinded Data Review Committee (DRC);Timepoint(s) of evaluation of this end point: Overall response at 2 weeks after EOT (FU1) as determined by the independent blinded DRC.<br><br><br>
- Secondary Outcome Measures
Name Time Method