Pharmacokinetic Study of Fluconazole in Premature Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01683760
First received: September 9, 2012
Last updated: November 17, 2014
Last verified: November 2014
  Purpose
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   up to 4 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683760

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

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01683760     History of Changes
Other Study ID Numbers: FLU_PK  12172_231 
Study First Received: September 9, 2012
Last Updated: November 17, 2014
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Fluconazole

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Fluconazole
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

ClinicalTrials.gov processed this record on August 30, 2016