Chronic Renal Failure Clinical Trial
Official title:
Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children:A Multi-centre, Double-blind, Randomized, Placebo-controlled, Clinical Trial
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 14 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Qatar | Hamad Medical Corporation | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation |
Qatar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal scarring comparatively with patients those don't take the medicine | Division of Children With Renal Scarring at the Outcome of (DMSA) Renal Scan [ Time Frame: The outcome DMSA scan will be 6 months from enrollment.] Renal scarring is defined as decreased uptake of tracer with or without loss of contours.
Three radiologists independently will review all renal DMSA scans for scarring . Diagnosis of presence or absence of renal scarring for a kidney , should be endorsed by the majority of readers (2/3). The child will be determined to have renal scarring if either kidney or both kidneys have scarring by the majority of readers. |
6 months |
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