Corticosteroids for Children With Febrile Urinary Tract Infections

• Status: Completed
• Trial end date: 2018-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nader Shaikh; University of Pittsburgh
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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)