Corticosteroids for Children With Febrile Urinary Tract Infections

NCT01391793 | Completed Phase 3 Results DMC

• 1 other identifier: R01DK087870
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Urinary Tract Infection; Urinary Tract Infection

Keywords

Renal scarring; Dexamethasone; Child; Corticosteroids; Pediatric; Urinary tract infection; Escherichia Coli Urinary Tract Infection

Outcome Measures

Primary Outcomes (2)

• The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan

  Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.

  The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

• The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan

  Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.

  The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Secondary Outcomes (1)

• The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists

  The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Study Arms (2)

Adjuvant dexamethasone

ACTIVE COMPARATOR

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Twice daily for 3 days

Also known as: Inactive medicine

Placebo

Dexamethasone DRUG

0.15 mg/kg/dose twice daily for 3 days

Also known as: Prelone, Orapred, Corticosteroid

Adjuvant dexamethasone

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Nader Shaikh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

Children's National Medical Center

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

Location

Nationwide Children's Hospital in Columbus

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 34251495 DERIVED

• 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.

  PMID: 32556960 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Dexamethasone; Methylprednisolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Nader Shaikh, MD, MPH
• Organization: UPMC Children's Hospital of Pittsburgh

nader.shaikh@chp.edu

412-692-8111

Study Officials

• Nader Shaikh, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: September 1, 2011
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)