Corticosteroids for Children With Febrile Urinary Tract Infections (NCT01391793) | Clinical Trial Compass
CompletedPhase 3
Corticosteroids for Children With Febrile Urinary Tract Infections
United States546 participantsStarted 2011-09
Plain-language summary
In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
Who can participate
Age range2 Months – 6 Years
SexALL
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Inclusion Criteria:
* Age: 2 months to 6 years
* Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged specimen or ≥1+ leukocyte esterase (LE) on dipstick
* Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the body either at home or at doctor's office within 24 hours of diagnosis
Exclusion Criteria:
* Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;
* Planned admission to intensive care unit;
* Known bacteremia;
* Previous protocol defined UTI;
* Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic bladder, pelvic or fused kidney);
* Congenital/acquired immunodeficiency;
* Bag urine collection
* Chronic diseases that could potentially interfere with response to therapy, such as chronic gastrointestinal conditions (i.e. malabsorption, inflammatory bowel disease), liver/kidney failure;
* Allergy to dexamethasone
* Antibiotic use within 7 days of enrollment (except if given in the last 48 hours)
* Systemic use of corticosteroids or other immunomodulating agents within 14 days of enrollment
* History of Kawasaki disease
* Sickle cell disease (not trait)
What they're measuring
1
The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan
Timeframe: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
2
The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan
Timeframe: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.