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

NCT04654507 | Unknown Phase 3 DMC

• 1 other identifier: MRC-01-20-085
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Tract Infections in Children; Dexamethasone; Kidney Scarring; Acute Pyelonephritis; Hypertension in Children; Chronic Renal Failure; UTI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Adjuvant dexamethasone

ACTIVE COMPARATOR

Drug: Dexamethasone

Drug: Dexamethasone Oral

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

Dexamethasone Oral DRUG

Drug: Dexamethasone 0.3mg/kg/dose twice daily for 3 days

Also known as: corticosteroids

Adjuvant dexamethasone

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 2 Months - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis; Kidney Failure, Chronic

Interventions

Dexamethasone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mahmoud Alhandi Omar Helal

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alhandi Omar Helal

CONTACT

50074001; dr.mahmoud.helal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 4, 2020
• Study Start: March 3, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)