Pharmacokinetic Study of Fluconazole in Premature Infants

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Interventions

  • Drug: Fluconazole
    • Prophylactic fluconazole administration in VLBW infants

Arms, Groups and Cohorts

  • Experimental: Population PK

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 4 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Han-Suk Kim, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Han-Suk Kim, MD, PhD, Principal Investigator, Seoul National University Hospital

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