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
Phase 2
16 Years
N/A
16 Years
N/A
Not Enrolling
Both
Aspergillosis
Both
Aspergillosis
Trial Information
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.
Inclusion Criteria
- Patients must meet a specific definition of probable or definite invasive
aspergillosis and be considered to have failed or be intolerant of standard
antifungal therapy.
- 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
enrollment.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tolerability.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_400
NCT ID:
NCT00076869
Start Date:
January 2003
Completion Date:
Related Keywords:
- Aspergillosis
- Definite or probable Invasive Aspergillosis either refractory or intolerant to prior antifungal treatment.
- Aspergillosis
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