Status:
TERMINATED
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Candidiasis
Eligibility:
All Genders
48-120 years
Phase:
PHASE3
Brief Summary
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
Detailed Description
Neonates and young infants will be stratified by estimated gestational age and by world region
Eligibility Criteria
Inclusion
- Infant greater than 48 hours of life after birth up to day of life 120 at the time of culture acquisition
- Diagnosis of proven invasive candidiasis within 4 days prior to study start
- Subject's parent or legal guardian agrees not to allow subject to participate in another study with another investigational drug while on treatment.
Exclusion
- Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or systemic amphotericin B product
- Infant who has received more than 48 hours of systemic antifungal therapy prior to the first dose of study drug
- Infant who has a breakthrough systemic fungal infection while receiving amphotericin B product or an echinocandin as prophylaxis
- Infant who has failed prior systemic antifungal therapy for this episode of invasive candidiasis
- Infant who is co-infected with a non-Candida fungal organism
- Infant whose positive yeast cultures are solely from an indwelling bladder catheter (unless obtained at the time the indwelling catheter was placed) or sputum.
- Infant previously enrolled in this study
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00815516
Start Date
February 1 2013
End Date
December 1 2014
Last Update
November 4 2015
Active Locations (17)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
UMDNJ/Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
3
Duke University
Durham, North Carolina, United States, 27710
4
WakeMed Health and Hospitals
Raleigh, North Carolina, United States, 27610