Phase 3
Completed N=546
Corticosteroids for Children With Febrile Urinary Tract Infections
Acute Urinary Tract Infection · Urinary Tract Infections
Source: ClinicalTrials.gov NCT01391793 ↗
Enrolled (actual)
546
Serious AEs
3.3%
Results posted
Jul 2019
Primary outcomePrimary: The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan — 12; 22; 111; 109 Participants — p=0.16
◆ Published Evidence
Established
33citations · ~6 / year
Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial.
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.
Linked Publications (2)
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Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial.
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Biomarkers for febrile urinary tract infection in children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan |
12; 22; 111; 109 | 0.16 |
| PRIMARY The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan |
0; 3; 123; 128 | 0.25 |
| SECONDARY The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists |
0.127; 0.204 | 0.07 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01391793) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.