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Corticosteroids for Children With Febrile Urinary Tract Infections (STARRS)

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ClinicalTrials.gov Identifier: NCT01391793
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Nader Shaikh, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Acute Urinary Tract Infection Urinary Tract Infection Drug: Placebo Drug: Dexamethasone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Corticosteroids for Children With Febrile Urinary Tract Infections
Study Start Date : September 2011
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Adjuvant dexamethasone Drug: Dexamethasone
0.15 mg/kg/dose twice daily for 3 days
Other Names:
  • Prelone
  • Orapred
  • Corticosteroid

Placebo Comparator: Placebo Drug: Placebo
Twice daily for 3 days
Other Name: Inactive medicine




Primary Outcome Measures :
  1. The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan [ Time Frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1. ]
    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.

  2. The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan [ Time Frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1. ]
    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.


Secondary Outcome Measures :
  1. The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists [ Time Frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1. ]
    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.



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Ages Eligible for Study:   2 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391793


Locations
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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Ohio
Nationwide Children's Hospital in Columbus
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Wisconsin
American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Nader Shaikh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Nader Shaikh, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Nader Shaikh, University of Pittsburgh:
Informed Consent Form  [PDF] November 17, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nader Shaikh, Assistant Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01391793    
Other Study ID Numbers: R01DK087870 ( U.S. NIH Grant/Contract )
R01DK087870 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2011    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nader Shaikh, University of Pittsburgh:
Renal scarring
Dexamethasone
Child
Corticosteroids
Pediatric
Urinary tract infection
Escherichia Coli Urinary Tract Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents