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Pharmacokinetic Study of Fluconazole in Premature Infants

This study has been completed.
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital Identifier:
First received: September 9, 2012
Last updated: November 17, 2014
Last verified: November 2014
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.

Condition Intervention Phase
Very Low Birth Weight Infant Drug: Fluconazole Phase 2

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

Resource links provided by NLM:

Further study details as provided by Han-Suk Kim, Seoul National University Hospital:

Primary Outcome 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

Enrollment: 80
Study Start Date: September 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Population PK Drug: Fluconazole
Prophylactic fluconazole administration in VLBW infants


Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01683760

Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Han-Suk Kim, MD, PhD Seoul National University Hospital
  More Information

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital Identifier: NCT01683760     History of Changes
Other Study ID Numbers: FLU_PK
12172_231 ( Other Grant/Funding Number: Korea Food and Drug Administration )
Study First Received: September 9, 2012
Last Updated: November 17, 2014

Keywords provided by Han-Suk Kim, Seoul National University Hospital:

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors processed this record on August 23, 2017