Pharmacokinetic Study of Fluconazole in Premature Infants

Very Low Birth Weight Infant Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683760
• Other study ID #: FLU_PK
• Secondary ID: 12172_231
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2012
• Last updated: November 17, 2014
• Start date: September 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infant

Intervention

Drug:
• Fluconazole
Prophylactic fluconazole administration in VLBW infants

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drug level of fluconazole	four times drug level after 3th dose	30min later, 10-12hr later, at routine lab with interval of 1week	No