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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00308906
Date of registration: 29/03/2006
Primary sponsor: Virginia Commonwealth University
Public title: Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-Treated Children
Scientific title: Assessment of Gene and Urinary Protein Expression in Aminoglycoside-Treated and Untreated Infants, Children and Adolescents
Date of first enrolment: June 2006
Target sample size: 166
Recruitment status: Suspended
URL:  http://clinicaltrials.gov/show/NCT00308906
Study type:  Observational
Study design:  Observational Model: Case Control, Time Perspective: Prospective  
Countries of recruitment
United States
Contacts
Name:   Mary Jayne Kennedy, Pharm.D.
Address: 
Telephone:
Email:
Affiliation:  Virginia Commonwealth University
Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Infection
Renal Dysfunction
Intervention(s)
Drug: aminoglycoside
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Aminoglycoside Waste Specimen
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Louisville
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