Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Daniel Benjamin
With
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Thrasher Research Fund
Food and Drug Administration (FDA)
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.
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
