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

Overview

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.

Full Title of Study: “Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2010

Interventions

  • Drug: aminoglycoside
    • Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.

Arms, Groups and Cohorts

  • 1
    • Hospitalized, untreated infants and children
  • 2
    • Aminoglycoside treated infants and children without renal injury
  • 3
    • Aminoglycoside treated infants with renal injury

Clinical Trial Outcome Measures

Primary Measures

  • Indicators of renal injury
    • Time Frame: Pre and post treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Collaborator
    • University of Louisville
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mary Jayne Kennedy, Associate Professor – Virginia Commonwealth University
  • Overall Official(s)
    • Mary Jayne Kennedy, Pharm.D., Principal Investigator, Virginia Commonwealth University

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