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

Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01851954

Enrollment

Registered

2013-05-13

Start date

2013-02-28

Completion date

2014-04-30

Last updated

2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureaplasma/Mycoplasma Positive, Very Low Birth Weight Infant

Brief summary

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

Interventions

DRUGClarithromycin

IV clarithromycin infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* sepsis, hypotension, shock * major congenital anomaly

Design outcomes

Primary

Measure	Time frame	Description
pharmacokinetics	72 hours after first infusion	AUC, Cmax

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026