Corticosteroids for Children With Febrile Urinary Tract Infections

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Urinary Tract Infection, Urinary Tract Infection

In brief

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

Key facts

Study ID

NCT01391793

Run by

Nader Shaikh

People needed

546

Starts

2011-09-01

Expected to finish

2018-03-30

Last updated by the study team

2019-07-02

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Nationwide Children's Hospital in Columbus — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Hasbro Children's Hospital — Providence, Rhode Island, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• American Family Children's Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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