Pharmacokinetic Study of Fluconazole in Premature Infants

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Very Low Birth Weight Infant

Treatments: Drug: Fluconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01683760

12172_231 (Other Grant/Funding Number)

FLU_PK

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: Under 4 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Population PK

Experimental group

Treatment:

Drug: Fluconazole