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

NCT04654507 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-07-25

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone Oral

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Mahmoud Alhandi Omar Helal · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Qatar

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654507 on ClinicalTrials.gov