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Corticosteroids to Reduce Renal Scarring in Children with Acute Pyelonephritis
NCT04654507Phase 3
Key facts
- Status
- Unknown
- Start
- Mar 2021
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Hamad Medical Corporation
- Modality
- Orthosteric Ligands
- Drugs
- dexamethasone
- Conditions
- acute pyelonephritis
01
Overview
Phase 3, randomised, double-blind trial in acute pyelonephritis comparing Adjuvant dexamethasone with Placebo (2 arms). Primary endpoint: Renal scarring comparatively with patients those don't take the medicine at 6 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Adjuvant dexamethasone
Dexamethasone 0.3 mg/kg twice daily for 3 days
Placebo
Placebo matching dexamethasone
03
Who it enrols
Children aged 2 months to 14 years with a first episode of acute febrile UTI/pyelonephritis (fever >= 38.3°C). Excludes those with previous UTI, renal scarring, urinary tract abnormalities (except VUR), or antibiotic use within 7 days (except last 48 hours).
04
Endpoints
Primary
Renal scarring comparatively with patients those don't take the medicine
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