Corticosteroids for Children With Febrile Urinary Tract Infections (STARRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01391793
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : April 23, 2018
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 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  (Clinical Trial)
Actual Enrollment : 505 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

U.S. FDA Resources

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 proportion of children who have any renal scars on the outcome DMSA scan [ Time Frame: 6 months after the index UTI if no reinfection during the study period or 4 months after the last reinfection reinfection. ]

Secondary Outcome Measures :
  1. The proportion of children with grades 3 or 4 scarring on at least one kidney (as defined in the study protocol). [ Time Frame: Same as for primary outcome ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age: 2 months to 6 years
  • Pyuria (≥10 WBC/mm3 in an uncentrifuged specimen or ≥5 WBC/hpf in a centrifuged specimen or ≥1+ leukocyte esterase 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 identifier (NCT number): NCT01391793

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, 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)
Principal Investigator: Nader Shaikh, MD University of Pittsburgh

Responsible Party: Nader Shaikh, Assistant Professor of Pediatrics, University of Pittsburgh Identifier: NCT01391793     History of Changes
Other Study ID Numbers: R01DK087870 ( U.S. NIH Grant/Contract )
R01DK087870 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nader Shaikh, University of Pittsburgh:
Renal scarring
Urinary tract infection
Escherichia Coli Urinary Tract Infection

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action