Research

Candidiasis Treatment with Micafungin in Neonates – Phase III

A Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis

Protocol Description

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.

Study Level: Phase III

Eligibility Criteria

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

Requirements
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

Status: Open for Enrollment

Source(s) of Support
Astellas Pharma Global Development, Inc.

Additional Information
Study description at National Institutes of Health