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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01851954
First received: April 12, 2013
Last updated: June 9, 2014
Last verified: June 2014
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 Seoul National University Hospital:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 72 hours after first infusion ] [ Designated as safety issue: No ]
    AUC, Cmax


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clarithromycin
Population PK
Drug: Clarithromycin
IV clarithromycin infusion

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851954

Contacts
Contact: Seung Han Shin, MD revival421@empal.com

Locations
Korea, Republic of
Seoul National University Children's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung Han Shin, MD       revival421@empal.com   
Principal Investigator: Han-Suk Kim, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Han-Suk Kim Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01851954     History of Changes
Other Study ID Numbers: clarith_VLBW
Study First Received: April 12, 2013
Last Updated: June 9, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014