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NCT01851954 Clinical Trial

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

Very Low Birth Weight Infant Clinical Trial

Official title:
Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01851954
Other study ID # clarith_VLBW
Secondary ID
Status Terminated
Phase Phase 2
First received April 12, 2013
Last updated November 17, 2014
Start date February 2013
Est. completion date April 2014

Study information
Verified date November 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Month
Eligibility Inclusion Criteria:

- birthweight < 1500gm or GA < 32 weeks

- transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)

Exclusion Criteria:

- sepsis, hypotension, shock

- major congenital anomaly

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Clarithromycin
IV clarithromycin infusion

Locations
Country Name City State
Korea, Republic of Seoul National University Children's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary pharmacokinetics AUC, Cmax 72 hours after first infusion No
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