NCT01683760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2.1 years

First QC Date

September 9, 2012

Last Update Submit

November 17, 2014

Conditions

Very Low Birth Weight Infant

Keywords

Fluconazole

Outcome Measures

Primary Outcomes (1)

  • drug level of fluconazole

    four times drug level after 3th dose

    30min later, 10-12hr later, at routine lab with interval of 1week

Study Arms (1)

Population PK

EXPERIMENTAL
Drug: Fluconazole

Interventions

FluconazoleDRUG

Prophylactic fluconazole administration in VLBW infants

Population PK

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Children's Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30910892DERIVED

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Han-Suk Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2012

First Posted

September 12, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

KR(1)