BAL8557 Versus Voriconazole in Invasive Fungal Disease (WSA-CS-004)

• Research type

  Research Study

• Full title

  A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi

• IRAS ID

  92708

• Contact name

  William Hope

• Sponsor organisation

  Astellas Pharma Global Development, Inc. (APGD)

• Eudract number

  2006-003868-59

• Research summary

  This phase 3, randomised, double-blind study is being funded by Astellas Pharma Global Development, Inc. (APGD). The research aims to establish the safety and efficacy of isavuconazole (the study medication, administered as an intravenous (IV) infusion and oral capsules), for the treatment of serious fungal infections compared to the current standard treatment drug voriconazole. Antifungal agents currently in use for the treatment of systemic fungal infections include the polyenes (Amphotericin B) and the azoles (imidazoles and triazoles). However, their use with systemic fungal infections are associated with a high failure rate and unfavorable side effects. The result being that the treatments for systemic fungal infections are often poorly tolerated in critically ill patients. Because of the toxicity associated with current treatments, there is a clinical need for the introduction of new treatments that are effective against a wide range of organisms, with a reduced toxicity profile and also can be given both intravenously and orally. Approximately 510 patients aged 18 or over will take part in this study and will be involved in the study up to 16 weeks which includes 12 weeks of study medication. Patients will be required to provide blood and urine samples at intervals throughout the study to assess efficacy and monitor patient safety. The study will take place in approximately 150 sites worldwide.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0006

• Date of REC Opinion

  21 Mar 2012

• REC opinion

  Further Information Favourable Opinion