Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children (NCT04654507) | Clinical Trial Compass
UnknownPhase 3
Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children
Qatar120 participantsStarted 2021-03-03
Plain-language 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.
Who can participate
Age range
2 Months – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Renal scarring comparatively with patients those don't take the medicine