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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
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital

Study Description
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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 Design
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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
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

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

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


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


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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Han-Suk Kim Seoul National University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Clarithromycin
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