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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection Renal Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Hospitalized, untreated infants and children

aminoglycoside

Intervention Type DRUG

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

aminoglycoside

Intervention Type DRUG

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

3

Aminoglycoside treated infants with renal injury

aminoglycoside

Intervention Type DRUG

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

Interventions

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aminoglycoside

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No