Placebo
DrugTwice daily for 3 days
Other names: Inactive medicine
NCT Number: NCT01391793
In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
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Notify Me2 month–6 year
All sexes
Interventional
Phase 3
Children's National Medical Center, Washington D.C., District of Columbia, United States
Because host inflammatory response is the final and most important step in the formation of renal scars, the use of anti-inflammatory agents may be the best strategy to reduce renal scarring. In animal studies, the use of corticosteroids has been shown to be effective in preventing post-pyelonephritic scarring. We will conduct a randomized, double-blind, placebo-controlled trial to determine the efficacy of 3 days of daily adjuvant dexamethasone on the incidence of renal scarring 4 to 6 months after a first febrile urinary tract infection (UTI). We hypothesize that the proportion of children with UTI who develop renal scarring will be lower among children who are treated with both dexamethasone and antibiotics as compared with children treated with antibiotics alone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Twice daily for 3 days
Other names: Inactive medicine
0.15 mg/kg/dose twice daily for 3 days
Other names: Prelone, Orapred, Corticosteroid
Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.
Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.
Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For each radiologist, for each child, if either kidney or both kidneys were diagnosed with scarring, then the child was determined to have renal scarring. For each radiologist, the proportion of children with scarring in a given treatment group is the number of children diagnosed with scarring divided by the number of children in the treatment group. The mean proportion of children with scarring in a given treatment group is the average proportion taken across the 3 radiologists.
Nader Shaikh
Other
Acronym: STARRS
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