Pharmacokinetic Study of Fluconazole in Premature Infants

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Fluconazole

Criteria

Inclusion Criteria:

• very low birth weight infant (birth weight < 1,500 g) who were admitted to the NICU before day 3 of life

• Informed consent from the parents

Exclusion Criteria:

• Major congenital anomaly

• Expired within 72 hours of life

• Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher)

• Proven congenital or intrauterine fungal infection