Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-Treated Children

This study has been suspended.

( Pending IRB approval at PI's new institution )

First Received: March 29, 2006 Last Updated: March 17, 2009 History of Changes

Sponsors and Collaborators:	Virginia Commonwealth University University of Louisville
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00308906

Purpose

The purposes of this study are to identify potential gene and protein markers of aminoglycoside-induced kidney injury in infants, children and adolescents treated with aminoglycoside antibiotics.

Condition	Intervention
Infection Renal Dysfunction	Drug: aminoglycoside

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Assessment of Gene and Urinary Protein Expression in Aminoglycoside-Treated and Untreated Infants, Children and Adolescents

Further study details as provided by Virginia Commonwealth University:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Waste blood samples will be collected in order to evaluate potential genetic mechanisms of aminoglyoside induced renal injury. Waste urine samples will be collected in order to evaluate candidate protein biomarkers of aminoglycoside induced renal injury.

Enrollment:	166
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Hospitalized, untreated infants and children	Drug: aminoglycoside Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.
2 Aminoglycoside treated infants and children without renal injury	Drug: aminoglycoside Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.
3 Aminoglycoside treated infants with renal injury	Drug: aminoglycoside Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Aminoglycoside treated and untreated newborns, infants and children.

Criteria

Inclusion Criteria: (1) Hospitalized male and female newborns, infants, children and adolescents (ages birth to 18 years) with a diagnosis of suspected or proven bacterial sepsis, meningitis or other indication necessitating aminoglycoside therapy (2) hospitalized and outpatient newborns, infants, children and adolescents (ages birth to 18 years) who are not receiving aminoglycoside therapy.

Exclusion Criteria: (1) Current treatment with inhaled or ophthalmic aminoglycosides (2) Prior treatment with an aminoglycoside within the last 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308906

Locations

United States, Kentucky
University of Lousiville
Louisville, Kentucky, United States, 40202
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

University of Louisville

Investigators

Principal Investigator:

Mary Jayne Kennedy, Pharm.D.

Virginia Commonwealth University

More Information

No publications provided

Responsible Party:	Virginia Commonwealth University ( Mary Jayne Kennedy, Pharm.D. )
Study ID Numbers:	Aminoglycoside Waste Specimen
Study First Received:	March 29, 2006
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00308906 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

infection
renal dysfunction
aminoglycoside
protein
child

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on May 06, 2009