Back to resultsPharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
Primary Purpose
Very Low Birth Weight Infant, Ureaplasma/Mycoplasma Positive
Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clarithromycin
Sponsored by
About this trial
This is an interventional prevention trial for Very Low Birth Weight Infant
Eligibility Criteria
Inclusion Criteria:
- birthweight < 1500gm or GA < 32 weeks
- transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)
Exclusion Criteria:
- sepsis, hypotension, shock
- major congenital anomaly
Sites / Locations
- Seoul National University Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
clarithromycin
Arm Description
Population PK
Outcomes
Primary Outcome Measures
pharmacokinetics
AUC, Cmax
Secondary Outcome Measures
Full Information
NCT ID
NCT01851954
First Posted
April 12, 2013
Last Updated
November 17, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01851954
Brief Title
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
Official Title
Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
declined enrollment
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infant, Ureaplasma/Mycoplasma Positive
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clarithromycin
Arm Type
Experimental
Arm Description
Population PK
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
IV clarithromycin infusion
Primary Outcome Measure Information:
Title
pharmacokinetics
Description
AUC, Cmax
Time Frame
72 hours after first infusion
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
birthweight < 1500gm or GA < 32 weeks
transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)
Exclusion Criteria:
sepsis, hypotension, shock
major congenital anomaly
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Suk Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
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