An observational study in Infection and Renal Dysfunction, sponsored by Virginia Commonwealth University. Completed at 2 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2016-02-02.
Sponsored by Virginia Commonwealth University · Observational
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 166 is above the median of 149 across 394 observational studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Aminoglycoside treated and untreated newborns, infants and children.
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
Hospitalized, untreated infants and children
Drug: aminoglycoside
Aminoglycoside treated infants and children without renal injury
Drug: aminoglycoside
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.
Indicators of renal injury
Time frame: Pre and post treatment
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University