Efficacy of Corticosteroids in Reducing the Renal Scarring in Acute Pyelonephritis in Children

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts 5 to 14% of emergency department visits Formation of renal scarring in children has been associated with serious complications as hypertension, preeclampsia, and end stage renal failure in young age . So, this study aims to determine whether dexamethasone reduces the renal scarring in children will be treated with antibiotics for acute pyelonephritis.

investigators propose to conduct a multi center, randomized, placebo-controlled, double-blind clinical trial, that will evaluate the efficacy of dexamethasone (0.3 mg/kg every 12 hours per day orally for 3 days) in preventing renal scarring in young febrile children (2 months to 14 years) with a first-diagnosed UTI. 120 Participants will be enrolled over a 3-year period from 6 sites.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• First episode of acute febrile UTI.

• From 2 months to 14 years of age.

• Fever: ≥ 38.3°C, measured at home or at Pediatric Emergency centers.,

Exclusion Criteria:

• Previous history of UTI.

• Urinary tract abnormalities except VUR.

• Antibiotic use within 7 days of enrollment (except last 48 hours)

• previous renal scarring

• patients included in the study and suffered second pyelonephritis during the first 6 months

• Patients allergic to dexamethasone.

• Endocrinology diseases.

• cancer.

• Planned admission to ICU

• Other bacterial infection as meningitis or pneumonia

• Congenital/acquired immunodeficiency

• Systemic use of corticosteroids or other immunomodulation agents within 14 days of enrollment.