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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

April 12, 2013
May 13, 2013
November 19, 2014
February 2013
April 2014   (Final data collection date for primary outcome measure)
pharmacokinetics [ Time Frame: 72 hours after first infusion ]
AUC, Cmax
Same as current
Complete list of historical versions of study NCT01851954 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Very Low Birth Weight Infant
  • Ureaplasma/Mycoplasma Positive
Drug: Clarithromycin
IV clarithromycin infusion
Experimental: clarithromycin
Population PK
Intervention: Drug: Clarithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
20
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • birthweight < 1500gm or GA < 32 weeks
  • transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)

Exclusion Criteria:

  • sepsis, hypotension, shock
  • major congenital anomaly
Sexes Eligible for Study: All
up to 1 Month   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01851954
clarith_VLBW
Yes
Not Provided
Not Provided
Han-Suk Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Han-Suk Kim Seoul National University Hospital
Seoul National University Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP