MedDataX Logo

Pharmacokinetic Study of Fluconazole in Premature Infants

NCT ID: NCT01683760

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Very Low Birth Weight Infant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Population PK

Group Type EXPERIMENTAL

Fluconazole

Intervention Type DRUG

Prophylactic fluconazole administration in VLBW infants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluconazole

Prophylactic fluconazole administration in VLBW infants

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Han-Suk Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Han-Suk Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30910892 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12172_231

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FLU_PK

Identifier Type: -

Identifier Source: org_study_id