Corticosteroids for Children With Febrile Urinary Tract Infections

Last updated: June 24, 2019
Sponsor: Nader Shaikh
Overall Status: Completed

Phase

3

Condition

Urinary Tract Infections

Urinary Incontinence

Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT01391793
R01DK087870
R01DK087870
  • Ages 2-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 2 months to 6 years

  • Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifugedspecimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifugedspecimen or ≥1+ leukocyte esterase (LE) on dipstick

  • Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on thebody either at home or at doctor's office within 24 hours of diagnosis

Exclusion

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, urethralvalve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenicbladder, pelvic or fused kidney);

  • Congenital/acquired immunodeficiency;

  • Bag urine collection

  • Chronic diseases that could potentially interfere with response to therapy, such aschronic 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 ofenrollment

  • History of Kawasaki disease

  • Sickle cell disease (not trait)

Study Design

Total Participants: 546
Study Start date:
September 01, 2011
Estimated Completion Date:
March 30, 2018

Study 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.

Connect with a study center

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Nationwide Children's Hospital in Columbus

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Hasbro Children's Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • American Family Children's Hospital

    Madison, Wisconsin 53792
    United States

    Site Not Available

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