Back to resultsPharmacokinetic Study of Fluconazole in Premature Infants
Primary Purpose
Very Low Birth Weight Infant
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluconazole
Sponsored by
About this trial
This is an interventional basic science trial for Very Low Birth Weight Infant focused on measuring Fluconazole
Eligibility 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
Sites / Locations
- Seoul National University Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Population PK
Arm Description
Outcomes
Primary Outcome Measures
drug level of fluconazole
four times drug level after 3th dose
Secondary Outcome Measures
Full Information
NCT ID
NCT01683760
First Posted
September 9, 2012
Last Updated
November 17, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01683760
Brief Title
Pharmacokinetic Study of Fluconazole in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infant
Keywords
Fluconazole
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Population PK
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Prophylactic fluconazole administration in VLBW infants
Primary Outcome Measure Information:
Title
drug level of fluconazole
Description
four times drug level after 3th dose
Time Frame
30min later, 10-12hr later, at routine lab with interval of 1week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Suk Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
30910892
Citation
Kim YK, Lee J, Oh J, Rhee SJ, Shin SH, Yoon SH, Lee S, Kim HS, Yu KS. Population Pharmacokinetic Study of Prophylactic Fluconazole in Preterm Infants for Prevention of Invasive Candidiasis. Antimicrob Agents Chemother. 2019 May 24;63(6):e01960-18. doi: 10.1128/AAC.01960-18. Print 2019 Jun.
Results Reference
derived
Learn more about this trial
Pharmacokinetic Study of Fluconazole in Premature Infants
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