- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01391793
Corticosteroids for Children With Febrile Urinary Tract Infections (STARRS)
June 24, 2019 updated by: Nader Shaikh
In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
546
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital in Columbus
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Hasbro Children's Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Wisconsin
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Madison, Wisconsin, United States, 53792
- American Family Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Twice daily for 3 days
Other Names:
|
Active Comparator: Adjuvant dexamethasone
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0.15 mg/kg/dose twice daily for 3 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nader Shaikh, MD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
March 30, 2018
Study Completion (Actual)
March 30, 2018
Study Registration Dates
First Submitted
July 8, 2011
First Submitted That Met QC Criteria
July 11, 2011
First Posted (Estimate)
July 12, 2011
Study Record Updates
Last Update Posted (Actual)
July 2, 2019
Last Update Submitted That Met QC Criteria
June 24, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Infections
- Communicable Diseases
- Urinary Tract Infections
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- R01DK087870 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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