Using Dexamethasone to Prevent Kidney Scarring in Children with Urinary Tract Infections
Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children:A Multi-centre, Double-blind, Randomized, Placebo-controlled, Clinical Trial
This study is testing if giving dexamethasone to children with their first urinary tract infection can help prevent kidney damage.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 2 Months to 14 Years |
| Sex | All |
| Sponsor | Hamad Medical Corporation Industry-sponsored |
| Locations | 1 site (Doha) |
| Trial ID | NCT04654507 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of dexamethasone in reducing renal scarring in children aged 2 months to 14 years who are experiencing their first episode of acute pyelonephritis. The study is a multi-center, randomized, placebo-controlled, double-blind trial involving 120 participants over a 3-year period. Participants will receive either dexamethasone or a placebo alongside standard antibiotic treatment for their urinary tract infection. The goal is to determine if the anti-inflammatory properties of dexamethasone can prevent the formation of permanent kidney damage associated with urinary tract infections.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 months to 14 years experiencing their first episode of acute febrile urinary tract infection.
Not a fit: Patients with a history of urinary tract infections, urinary tract abnormalities, or those currently on corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of kidney scarring and its associated complications in young children.
How similar studies have performed: While the use of corticosteroids in similar contexts has been explored, this specific approach to preventing renal scarring in pediatric urinary tract infections is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Doha
- Hamad Medical Corporation — Doha, Qatar (Recruiting)
Study contacts
- Principal investigator: Mahmoud Alhandi Omar Helal — Hamad Medical Corporation
- Study coordinator: Mahmoud Alhandi Omar Helal
- Email: dr.mahmoud.helal@gmail.com
- Phone: 50074001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.