Corticosteroids for Children With Febrile Urinary Tract Infections

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 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.

Inclusion Criteria:

- Age: 2 months to 6 years

- Pyuria (≥10 WBC/mm3 in an uncentrifuged specimen or ≥5 WBC/hpf in a centrifuged
specimen or ≥1+ leukocyte esterase 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)