Corticosteroids for Children With Febrile Urinary Tract Infections (STARRS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by University of Pittsburgh
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Nader Shaikh, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01391793
First received: July 8, 2011
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Acute Urinary Tract Infection
Urinary Tract Infection
Drug: Placebo
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Corticosteroids for Children With Febrile Urinary Tract Infections

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: September 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   2 Months to 6 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391793

Contacts
Contact: Nader Shaikh, MD 412-692-8111 nader.shaikh@chp.edu
Contact: Diana Kearney, CCRC 412-692-6717 diana.kearney@chp.edu

Locations
United States, District of Columbia
Children's National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Ohio
Nationwide Children's Hospital in Columbus Active, not recruiting
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Principal Investigator: Nader Shaikh, MD         
Sub-Investigator: Alejandro Hoberman, MD         
United States, Rhode Island
Hasbro Children's Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, Wisconsin
American Family Children's Hospital Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Ellen R Wald, MD         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Nader Shaikh, MD University of Pittsburgh
  More Information

Responsible Party: Nader Shaikh, Assistant Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01391793     History of Changes
Other Study ID Numbers: R01DK087870 
Study First Received: July 8, 2011
Last Updated: July 20, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pittsburgh:
Renal scarring
Dexamethasone
Child
Corticosteroids
Pediatric
Urinary tract infection
Escherichia Coli Urinary Tract Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 29, 2016