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

NCT ID: NCT01851954

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-04-30

Brief Summary

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

Detailed Description

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Conditions

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Very Low Birth Weight Infant Ureaplasma/Mycoplasma Positive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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clarithromycin

Population PK

Group Type EXPERIMENTAL

Clarithromycin

Intervention Type DRUG

IV clarithromycin infusion

Interventions

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Clarithromycin

IV clarithromycin infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* sepsis, hypotension, shock
* major congenital anomaly
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Suk Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Suk Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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clarith_VLBW

Identifier Type: -

Identifier Source: org_study_id