Trial of Combination Antifungal Therapy (Vori+Mica vs. Vori+Placebo) in Invasive Aspergillosis



Status:Archived
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2010
End Date:March 2013

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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


The purpose of this study is to evaluate the therapeutic effectiveness of combination
antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo
equivalent as primary therapy for 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.


We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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mi
from
Little Rock, AR
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