Corticosteroids for Children With Febrile Urinary Tract Infections (STARRS)

Nader Shaikh

Status and phase

Completed

Phase 3

Conditions

Urinary Tract Infection

Acute Urinary Tract Infection

Treatments

Drug: Placebo

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01391793

R01DK087870 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.

Full description

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.

Enrollment

546 patients

Sex

All

Ages

2 months to 6 years old

Volunteers

No Healthy Volunteers

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)