Corticosteroids for Children With Febrile Urinary Tract Infections

Urinary Tract Infection Clinical Trial

— STARRS  

Official title:

Corticosteroids for Children With Febrile Urinary Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391793
• Other study ID #: R01DK087870
• Secondary ID: R01DK087870
• Status: Completed
• Phase: Phase 3
• Start date: September 2011
• Est. completion date: March 30, 2018

Study information

• Verified date: June 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 6 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Urinary Tract Infection
• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Placebo
Twice daily for 3 days
• Dexamethasone
0.15 mg/kg/dose twice daily for 3 days

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital in Columbus	Columbus	Ohio
United States	American Family Children's Hospital	Madison	Wisconsin
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	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Nader Shaikh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists	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 each radiologist, for each child, if either kidney or both kidneys were diagnosed with scarring, then the child was determined to have renal scarring. For each radiologist, the proportion of children with scarring in a given treatment group is the number of children diagnosed with scarring divided by the number of children in the treatment group. The mean proportion of children with scarring in a given treatment group is the average proportion taken across the 3 radiologists.	The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.