Oral steroids for reducing renal scarring in infants with febrile urinary tract infections at high risk for renal scar development: a randomized controlled trial

Phase 1

• Conditions: Infants with febrile UTI at higher risk for renal scar development based on PCT values = 1 ng/mL; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-000388-10-IT
• Lead Sponsor: AZIENDA ULSS N.9 - TREVISO, UOC PEDIATRIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-07
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Infants and children aged 2 months to 2 years with a first episode of presumed UTI based on fever; positive urinalysis (two concordant consecutive test results), with white cell counts =25/uL, =+1 with dipstick and/or positive nitrites; and a PCT value >1 ng/mL measured at the time of first evaluation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 184
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Antibiotic therapy in the 48 hours prior to evaluation; known underlying renal disease or urinary tract abnormalities; history of previous UTI and UTI recurrence before DMSA scan performance at 6 months for detection of renal scars; prematurity (<36 weeeks); immunodeficiencies; contraindications for use of steroids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the usefulness of steroid therapy (adjunctive to standard antibiotic treatment) in reducing renal scar development in infants with first febrile UTI, at higher risk based on PCT values = 1 ng/mL, measured at the time of initial evaluation<br>;Secondary Objective: To evaluate if the usefulness of adjunctive steroid therapy is greater in children with higher PCT values.<br>To evaluate the safety and acceptability of treatment.<br>To evaluate whether a metabolic profile exists predictive of scar development and/or associated with a positive response to Dexamethasone.<br>;Primary end point(s): Primary endpoint is the development of renal scars as identified by DMSA scan at 6 months after diagnosis of first febrile UTI.<br>;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Secondary endpoints include evaluation of adjunctive steroid therapy effectiveness in the subgroup of children with higher PCT values, in terms of renal scar development 2. Assessment of safety and acceptability of treatment, in terms of the rate of discontinuation of treatment and the incidence of side effects.<br>3.A further secondary endpoint will be the characterization of metabolic profiles associated with the development of renal scars and/or with the response to steroid therapy.<br>;Timepoint(s) of evaluation of this end point: 1. 6 months<br>2. 1 week<br>3. 36 months