NCT01851954

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1.2 years

First QC Date

April 12, 2013

Last Update Submit

November 17, 2014

Conditions

Very Low Birth Weight InfantUreaplasma/Mycoplasma Positive

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics

    AUC, Cmax

    72 hours after first infusion

Study Arms (1)

clarithromycin

EXPERIMENTAL

Population PK

Drug: Clarithromycin

Interventions

ClarithromycinDRUG

IV clarithromycin infusion

clarithromycin

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • sepsis, hypotension, shock
  • major congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Children's Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Clarithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Han-Suk Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2013

First Posted

May 13, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

KR(1)