Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)

Phase 2TerminatedNCT01851954

Seoul National University Hospital6 enrolled

Overview

The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Very Low Birth Weight Infant Ureaplasma/Mycoplasma Positive

Interventions

ClarithromycinDRUG

IV clarithromycin infusion

Eligibility

Sex: ALLMax age: 1 Month

Medical Language ↔ Plain English

Inclusion Criteria: * birthweight \< 1500gm or GA \< 32 weeks * transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+) Exclusion Criteria: * sepsis, hypotension, shock * major congenital anomaly

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

pharmacokinetics

AUC, Cmax

Time frame: 72 hours after first infusion

Data from ClinicalTrials.gov

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