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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Very Low Birth Weight Infant Ureaplasma/Mycoplasma Positive | Drug: Clarithromycin | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: clarithromycin
Population PK
|
Drug: Clarithromycin
IV clarithromycin infusion
|
- pharmacokinetics [ Time Frame: 72 hours after first infusion ]AUC, Cmax

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Ages Eligible for Study: | up to 1 Month (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- birthweight < 1500gm or GA < 32 weeks
- transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)
Exclusion Criteria:
- sepsis, hypotension, shock
- major congenital anomaly

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
Korea, Republic of | |
Seoul National University Children's Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Han-Suk Kim | Seoul National University Hospital |
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 |