Urinary Tract Infection Treatment with Corticosteroids (STARRS Study)

Protocol Description

The purpose of this interventional study is to determine if kidney damage (scarring) can be decreased or prevented by using corticosteroids for treatment of urinary tract infection (UTI) accompanied by fever. About 1 in 7 children with UTI develop kidney scarring due to swelling and irritation that comes with infection. In addition to observing the potential benefit of treatment with corticosteroids, this study will determine if genetic markers in the urine or blood can help predict which children may have kidney scarring and which germs cause scarring along with a kidney infection. The ultimate aim of this study is to help clinicians improve the care provided to children with UTI.

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to children of both genders who have been diagnosed with febrile UTI (UTI with fever).
Boys and Girls: At least 3 months of age but less than 6 years old

Requirements

Participants’ doctors will treat UTI in the usual way with antibiotics. As part of the study participants will also be given the corticosteroid medication, dexamethasone or a placebo, orally, twice a day for three days. In the initial visit a limited physical examination will be provided and urine and blood samples will be collected. Telephone follow-up will be provided to monitor when the child’s fever resolves, and monthly for 6 months thereafter. If during the 6-month follow-up the child experiences another UTI, the treatment procedure will be repeated. A DMSA kidney scan will be done to determine whether there is scarring in the kidney at 6 months after the initial UTI, or if the child has more than a single UTI, at least 4 months after the last.
Visits: 2
Duration: At least 6 months, depending on number of UTIs experienced

Status: Closed

Source(s) of Support

National Institute of Diabetes and Digestive and Kidney Diseases

Additional Information

Study Description at National Institutes of Health
DMSA Renal (Kidney) Scan

Primary Investigator

Nader Shaikh, MD

Contact Information

For information or to enroll, please contact the UTI Center:
412-692-UTIS (8847)