Treatment of Candidemia and other invasive Candida infections MedDRA version: 17.1 Level: LLT Classification code 10060573 Term: Candidemia System Organ Class: 100000004862
Conditions
Interventions
Product Name: Isavuconazonium sulphate
Product Code: BAL8557
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Isavuconazonium sulphate
Current Sponsor code: BAL8557
Concent
Sponsors
Astellas Global Pharma Development, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
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 -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Overall response as determined by the independent blinded DRC at other time points. -Mycological response as determined by the independent blinded DRC at other time points. -Clinical response as determined by the independent blinded DRC at other time points. -Mycological response as determined by the Investigator. -Clinical response as determined by the Investigator. -Time to first confirmed negative culture. -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 ] •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 ] •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 ] •Time to first confirmed negative culture [ Time Frame: Up to 2 weeks after last study drug ] [ Designated as 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 ] | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Hungary, India, Israel, Italy, Lebanon, Mexico, Netherlands, Russian Federation, Singapore, South Africa, Spain, Thailand, United Kingdom, United States
Contacts
Public Contactcontact@nl.astellas.com
Global Development Operations
Outcome results
None listed