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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000388-10-IT

Enrollment

184

Registered

2013-02-07

Start date

2013-03-30

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants with febrile UTI at higher risk for renal scar development based on PCT values = 1 ng/mL

Interventions

Product Name: DEXAMETHASONE Pharmaceutical Form: Oral drops INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE Concentration unit: mg/ml milligr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;Secondary Objective: To evaluate if the usefulness of adjunctive steroid therapy is greater in children with higher PCT values. To evaluate the safety and acceptability of treatment. To evaluate whether a metabolic profile exists predictive of scar development and/or associated with a positive response to Dexamethasone. ;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. ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

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 ;Secondary Objective: To evaluate if the usefulness of adjunctive steroid therapy is greater in children with higher PCT values. To evaluate the safety and acceptability of treatment. To evaluate whether a metabolic profile exists predictive of scar development and/or associated with a positive response to Dexamethasone. ;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. ;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
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. 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. ;Timepoint(s) of evaluation of this end point: 1. 6 months 2. 1 week 3. 36 months	—

Measure

Time frame

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. 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. ;Timepoint(s) of evaluation of this end point: 1. 6 months 2. 1 week 3. 36 months

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Countries

Italy

Contacts

Public ContactPROF.SSA LIVIANA DA DALT

AZIENDA ULSS N.9 - TREVISO, UOC PEDIATRIA

liviana.dadalt@unipd.it00390422322263

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026