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

Infection Clinical Trial

Official title:

Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308906
• Other study ID #: Aminoglycoside Waste Specimen
• Status: Completed
• Phase: N/A
• First received: March 29, 2006
• Last updated: January 30, 2016
• Start date: June 2006
• Est. completion date: December 2010

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Renal Dysfunction
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	University of Lousiville	Louisville	Kentucky
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indicators of renal injury		Pre and post treatment	No