A Phase II Randomized, Double Blind, Placebo-controlled, Trial of Combination Antifungal Therapy (Voriconazole Plus Micafungin vs. Voriconazole Plus Placebo Equivalent) in the Treatment of Invasive Aspergillosis (IA) in Patients With Hematological Cancer
Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous
(IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the
first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be
switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and
gastrointestinal functions are intact.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Response is defined as normalization of the serum Aspergillus galactomannan index (GMI)values (first normal GMI value is considered day of response).
maximum 6 weeks
Elias Anaissie, MD
University of Arkansas
United States: Food and Drug Administration
|University of Arkansas||Little Rock, Arkansas 72202|
|UAMS||Little Rock, Arkansas 72205|