Pharmacokinetic Study of Fluconazole in Premature Infants

Phase 2

Completed

• Conditions: Very Low Birth Weight Infant
• Interventions: Drug: Fluconazole

• Registration Number: NCT01683760
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-09
• Study First Submitted QC: 2012-09-09
• Study First Posted: 2012-09-12
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Population PK	Fluconazole	-

Primary Outcome Measures

Name	Time	Method
drug level of fluconazole	30min later, 10-12hr later, at routine lab with interval of 1week	four times drug level after 3th dose

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of