Trial Search Results

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Astellas Pharma Inc

Collaborator: Basilea Pharmaceutica International Ltd

Stanford Investigator(s):

Intervention(s):

  • Drug: Isavuconazole
  • Drug: Voriconazole

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must have proven, probable or possible invasive fungal disease caused by
   Aspergillus species or other filamentous fungi

   - Female patients must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

   - Patients with invasive fungal infections other than Aspergillus species or other
   filamentous fungi

   - Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction

   - Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary
   aspergillosis

   - Patients who have received more than 4 days of systemic antifungal therapy other than
   fluconazole within the 7 days prior to the first administration of study medication

   - Patients previously enrolled in a Phase III study with isavuconazole

   - Patients with a body weight

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822
Not Recruiting