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

This study has been terminated.

(declined enrollment)

Sponsor:

Information provided by (Responsible Party):

Han-Suk Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01851954

First received: April 12, 2013

Last updated: November 17, 2014

Last verified: November 2014

History of Changes

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:

MedlinePlus related topics: Birth Weight Body Weight

Drug Information available for: Clarithromycin

U.S. FDA Resources

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


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


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

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

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:	November 17, 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 March 03, 2015

To Top