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Pharmacokinetic Study of Fluconazole in Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01683760
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Han-Suk Kim, 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.

Condition or disease Intervention/treatment Phase
Very Low Birth Weight Infant Drug: Fluconazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : September 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: Population PK Drug: Fluconazole
Prophylactic fluconazole administration in VLBW infants

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683760

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Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Han-Suk Kim, MD, PhD Seoul National University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital Identifier: NCT01683760    
Other Study ID Numbers: FLU_PK
12172_231 ( Other Grant/Funding Number: Korea Food and Drug Administration )
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Han-Suk Kim, Seoul National University Hospital:
Additional relevant MeSH terms:
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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