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

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ClinicalTrials.gov Identifier: NCT00308906
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : February 2, 2016
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Mary Jayne Kennedy, Virginia Commonwealth University

Brief Summary:
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 or disease Intervention/treatment
Infection Renal Dysfunction Drug: aminoglycoside

Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents
Study Start Date : June 2006
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Indicators of renal injury [ Time Frame: Pre and post treatment ]

Biospecimen Retention:   Samples With DNA
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.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

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): 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

Responsible Party: Mary Jayne Kennedy, Associate Professor, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00308906     History of Changes
Other Study ID Numbers: Aminoglycoside Waste Specimen
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016

Keywords provided by Mary Jayne Kennedy, Virginia Commonwealth University:
infection
renal dysfunction
aminoglycoside
protein
child

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases