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

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ClinicalTrials.gov Identifier: NCT01851954
Recruitment Status : Terminated (declined enrollment)
First Posted : May 13, 2013
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation
Study Start Date : February 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Arm Intervention/treatment
Experimental: clarithromycin
Population PK
Drug: Clarithromycin
IV clarithromycin infusion

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01851954     History of Changes
Other Study ID Numbers: clarith_VLBW
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 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