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This multicenter study will evaluate micafungin compared to amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections. Candidiasis is a fungal infection caused by the Candida species (yeasts), and candidemia is the more serious, systemic form of the infection.
Subject to certain exclusion criteria, this study is open to infants of both genders up to 120 days old, who have been diagnosed with invasive candidiasis or candidemia.
Males and Females: Up to 120 days old
Following the initial screening exam, participants will be randomly selected to receive either the study drug or amphotericin B deoxycholate. Drugs will be administered intravenously (IV) for at least 21 days up to a maximum of 42 days. Blood and urine sampling will be done and other testing may be required, such as ultrasound, computed tomography or magnetic resonance imaging, echocardiogram, retinal exam and lumbar (spine) puncture to determine the extent of the disease. A follow-up will be done 30 days after the end of the dosing period.
Visits: Requires hospitalization
Duration: Up to 79 days, depending on response to treatment
Astellas Pharma Global Development, Inc.
Study description at National Institutes of Health
Judith Martin, MD
For enrollment information, please contact:
Diane Gwin, RN, BSN, MSN, CCRC
Noreen Jeffrey, RN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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