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

Seoul National University

Status and phase: Terminated; Phase 2

Conditions: Very Low Birth Weight Infant; Ureaplasma/Mycoplasma Positive

Treatments: Drug: Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01851954

clarith_VLBW

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• sepsis, hypotension, shock
• major congenital anomaly

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

clarithromycin

Experimental group

Description:

Population PK

Treatment:

Drug: Clarithromycin