WSA-CS-008 BAL8557 vs Caspofungin & Voriconazole in Candidemia

• Research type

  Research Study

• Full title

  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

• IRAS ID

  92906

• Contact name

  Abhijit Bal

• Sponsor organisation

  Astellas Pharma Global Development, Inc. (APGD)

• Eudract number

  2006-003951-18

• ISRCTN Number

  not issued

• Research summary

  Phase III double-blind, double-dummy, randomized group study of isavuconazole (ISA or BAL8557) versus caspofungin (CAS) followed by voriconazole (VRC) in the treatment of candidemia and other invasive Candida infections. A total of approximately 526 patients will be enrolled in the study at about 180 sites globally. Eligible patients must be at least 18 years old with candidemia or with an invasive Candida infection who have a positive blood or tissue culture (obtained within 96 hours prior to randomization) and related clinical signs and symptoms or changes. The study will be diveded in 3 periods a screening period (up to 5 days), a treatment period (up to 8 weeks) and a follow-up period (2 visits: one 2 weeks after end of treatment and another 6 weeks after end of treatment). During the study, patients will be placed into one of two treatment groups to receive either ISA or CAS followed by VCR theraphy or matching placebo as intravenuos infusion and oral capsules. Patients will have an equal chance of being placed in either group. The study will last approximately 22 months.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/0661

• Date of REC Opinion

  24 Jul 2012

• REC opinion

  Further Information Favourable Opinion