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

This study has been terminated.
(declined enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01851954
First Posted: May 13, 2013
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
  Purpose
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

  Eligibility

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
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
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

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01851954     History of Changes
Other Study ID Numbers: clarith_VLBW
First Submitted: April 12, 2013
First Posted: May 13, 2013
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