Status:
COMPLETED
Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
Lead Sponsor:
Daniel Benjamin
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Thrasher Research Fund
Conditions:
Candidiasis
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
Brief Summary
The most common etiology of infection-related death or neurodevelopmental impairment in neonates with birthweight \<750 g is invasive candidiasis. Over 70% of the premature neonates who develop invasi...
Detailed Description
362 subjects were randomized to the study at 33 US sites. Final study visits of Month 18-22 corrected age long term follow up were completed. Study database is locked.
Eligibility Criteria
Inclusion
- Informed consent from the legally authorized representative.
- \> 48 hours of age and \< 120 hours old at time of first drug administration
- \< 750 g birth weight
- Negative blood cultures for Candida
Exclusion
- History of a hypersensitivity or severe vasomotor reaction to any azole
- receiving antifungal therapy for suspected/proven invasive fungal infection
- medical condition, in the opinion of the Investigator, may create an unacceptable additional risk
- diagnosed with invasive candidiasis or congenital Candida infection.
- liver failure (AST and ALT \> 250 U/L)
- renal failure (creatinine \> 2 mg/dL)
- major lethal congenital or genetic anomalies
- triplet or higher multiple gestations
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00734539
Start Date
November 1 2008
End Date
April 1 2013
Last Update
March 1 2019
Active Locations (33)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
3
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72205
4
Children's Hospital of Orange County
Orange, California, United States, 92868