Pharmacokinetic Study of Fluconazole in Premature Infants

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

Completed

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Key information

Conditions

Very Low Birth Weight Infant

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Children's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluconazole

Drug

Prophylactic fluconazole administration in VLBW infants

Primary outcomes

drug level of fluconazole

Time frame: 30min later, 10-12hr later, at routine lab with interval of 1week

four times drug level after 3th dose

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Sep 12, 2012
Registry last updated: Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed