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

Phase 2

Terminated

• Conditions: Very Low Birth Weight Infant; Ureaplasma/Mycoplasma Positive
• Interventions: Drug: Clarithromycin

• Registration Number: NCT01851954
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-13
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• birthweight < 1500gm or GA < 32 weeks
• transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)

Exclusion Criteria

• sepsis, hypotension, shock
• major congenital anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clarithromycin	Clarithromycin	Population PK

Primary Outcome Measures

Name	Time	Method
pharmacokinetics	72 hours after first infusion	AUC, Cmax

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of