Corticosteroids for Children With Febrile Urinary Tract Infections

NCT ID: NCT01391793

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2018-03-30

Brief 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.

Detailed 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.

Conditions

Acute Urinary Tract Infection; Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Adjuvant dexamethasone

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

0.15 mg/kg/dose twice daily for 3 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Twice daily for 3 days

Interventions

Placebo

Twice daily for 3 days

Intervention Type: DRUG

Dexamethasone

0.15 mg/kg/dose twice daily for 3 days

Intervention Type: DRUG

Other Intervention Names

Inactive medicine; Prelone; Orapred; Corticosteroid

Eligibility 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)

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Nader Shaikh

OTHER

Sponsor Role: lead

Responsible Party

Nader Shaikh

Assistant Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nader Shaikh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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

Countries

United States

References

Shaikh N, Liu H, Kurs-Lasky M, Forster CS. Biomarkers for febrile urinary tract infection in children. Pediatr Nephrol. 2022 Jan;37(1):171-177. doi: 10.1007/s00467-021-05173-x. Epub 2021 Jul 12.

Reference Type: DERIVED

PMID: 34251495 (View on PubMed)

Shaikh N, Shope TR, Hoberman A, Muniz GB, Bhatnagar S, Nowalk A, Hickey RW, Michaels MG, Kearney D, Rockette HE, Charron M, Lim R, Majd M, Shalaby-Rana E, Kurs-Lasky M, Cohen DM, Wald ER, Lockhart G, Pohl HG, Martin JM. Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial. Pediatr Nephrol. 2020 Nov;35(11):2113-2120. doi: 10.1007/s00467-020-04622-3. Epub 2020 Jun 15.

Reference Type: DERIVED

PMID: 32556960 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK087870

Identifier Type: NIH

Identifier Source: secondary_id

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R01DK087870

Identifier Type: NIH

Identifier Source: org_study_id

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