Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis
Intervention: micafungin (Drug); amphotericin B deoxycholate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.
Overall contact:
Astellas Pharma US Medical Information, Phone: 800-888-7704, Ext: 5473, Email: clintrials.info@us.astellas.com
Summary
The study will evaluate how effective and how safe the drug micafungin is when compared to
the drug amphotericin B deoxycholate in treating infants with certain fungal infections.
Clinical Details
Official title: A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Fungal free survival
Detailed description:
Infants will be stratified by estimated gestational age and by world region
Eligibility
Minimum age: N/A.
Maximum age: 120 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Infant greater than 48 hours of life after birth up to day of life 120 at the time of
culture acquisition
- Diagnosis of invasive candidiasis or candidemia within 4 days prior to study start
Exclusion Criteria:
- Infant with any history of a hypersensitivity 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 or
sputum
Locations and Contacts
Astellas Pharma US Medical Information, Phone: 800-888-7704, Ext: 5473, Email: clintrials.info@us.astellas.com
Birmingham, Alabama 95233, United States; Recruiting
Wichita, Kansas 67214, United States; Not yet recruiting
Royal Oak, Michigan 48073, United States; Recruiting
Stony Brook, New York 11794, United States; Not yet recruiting
Valhalla, New York 10595, United States; Not yet recruiting
Nashville, Tennessee 37232, United States; Not yet recruiting
Salt Lake City, Utah 84132, United States; Not yet recruiting
Charlottesville, Virginia 22908, United States; Not yet recruiting
Additional Information
Starting date: December 2008
Ending date: September 2010
Last updated: January 28, 2009
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