A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of MK0991 in Combination With Amphotericin B, Lipid Formulations of Amphotericin B, or Azoles in the Treatment of Invasive Aspergillus Infection in Adults Who Are Refractory to or Intolerant of Standard Therapy
The duration of treatment is 12 months.
- Patients must meet a specific definition of probable or definite invasive
aspergillosis and be considered to have failed or be intolerant of standard
- The patient must be at least 16 years old and if a woman of childbearing potential,
must have a negative serum or urine pregnancy test sensitive to 25 IU hCG prior to
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
- Definite or probable Invasive Aspergillosis either refractory or intolerant to prior antifungal treatment.