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

This study has been terminated.
(declined enrollment)
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital Identifier:
First received: April 12, 2013
Last updated: November 17, 2014
Last verified: November 2014
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.

Condition Intervention Phase
Very Low Birth Weight Infant Ureaplasma/Mycoplasma Positive Drug: Clarithromycin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation

Resource links provided by NLM:

Further study details as provided by Han-Suk Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 72 hours after first infusion ]
    AUC, Cmax

Enrollment: 6
Study Start Date: February 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clarithromycin
Population PK
Drug: Clarithromycin
IV clarithromycin infusion


Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • sepsis, hypotension, shock
  • major congenital anomaly
  Contacts and Locations
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Please refer to this study by its identifier: NCT01851954

Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Han-Suk Kim Seoul National University Hospital
  More Information

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital Identifier: NCT01851954     History of Changes
Other Study ID Numbers: clarith_VLBW
Study First Received: April 12, 2013
Last Updated: November 17, 2014

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on September 19, 2017