Pharmacokinetic Study of Fluconazole in Premature Infants

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01683760

Enrollment

Registered

2012-09-12

Start date

2012-09-30

Completion date

2014-10-31

Last updated

2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Low Birth Weight Infant

Keywords

Fluconazole

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.

Interventions

DRUGFluconazole

Prophylactic fluconazole administration in VLBW infants

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 4 Weeks

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026