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

This study has been completed.
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Mary Jayne Kennedy, Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00308906
First received: March 29, 2006
Last updated: January 30, 2016
Last verified: January 2016
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Indicators of renal injury [ Time Frame: Pre and post treatment ] [ Designated as safety issue: No ]

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.

Enrollment: 166
Study Start Date: June 2006
Study Completion Date: December 2010
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   (Child, Adult)
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
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: 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

Responsible Party: Mary Jayne Kennedy, Associate Professor, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00308906     History of Changes
Other Study ID Numbers: Aminoglycoside Waste Specimen 
Study First Received: March 29, 2006
Last Updated: January 30, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
infection
renal dysfunction
aminoglycoside
protein
child

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 26, 2016