Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts for 5 to 14% of emergency department visits. UTIs can be divided into asymptomatic bacteriuria, cystitis, and acute pyelonephritis (APN ). The APN is associated with an increased risk of renal damage, acquired through renal scarring. Which is a consequence of the inflammatory and immune response that aim to eradicate the bacteria involved in the UTI. Parenchymal infection can be solved, but there are a number of poorly understood factors that may perpetuate inflammation, and this would promote the formation of scarring. One of the most relevant factors involved in formation of renal scarring is the production of inflammatory mediators (complement proteins, bactericidal peptides, cytokines , chemokines, ). hence, the use of anti-inflammatory drugs may prevent the release of these mediators and the formation of permanent renal scarring. Renal scarring in childhood has been associated with serious complications as hypertension, preeclampsia, and ESRD in young age. Current treatment of children with UTI has focused on the treatment of vesicoureteral reflux (VUR) and on the early treatment of UTI with antibiotics. Although the presence of VUR increases the likelihood of bacteria gaining access to the kidney, correction of VUR is not sufficient to prevent scarring. Renal scarring frequently occurs in children who do not have VUR, and early diagnosis and treatment of children with VUR is not associated with a reduction in the incidence of end-stage renal disease. Similarly, early antibiotic therapy is necessary, but it is not sufficient to prevent renal scarring in most children with UTI. Because signs of UTI in children are relatively non-specific, the diagnosis is often delayed. data from many studies have shown that once the infection has localized to the renal parenchyma, treatment with antibiotics alone does not prevent scarring. hence ,It is clear that the current management is not always effective in preventing renal scarring. The proposed study aims to determine whether dexamethasone therapy - which focuses on modulation of the host inflammatory response - is effective in reducing renal scarring. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04654507
Study type Interventional
Source Hamad Medical Corporation
Contact Mahmoud Alhandi Omar Helal
Phone 50074001
Email dr.mahmoud.helal@gmail.com
Status Recruiting
Phase Phase 3
Start date March 3, 2021
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT02565459 - MSC and Kidney Transplant Tolerance (Phase A) Phase 1
Recruiting NCT02356419 - rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics Phase 1
Recruiting NCT01876017 - Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure Phase 1/Phase 2
Withdrawn NCT03019159 - Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis N/A
Completed NCT02047006 - Dose-finding of Rivaroxaban in Hemodialysis Phase 4
Completed NCT01617824 - Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes Phase 4
Completed NCT00597753 - Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis Phase 3
Completed NCT00828776 - Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure Phase 2/Phase 3
Terminated NCT00372489 - Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD Phase 2
Completed NCT00379899 - ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis Phase 4
Completed NCT00228436 - Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients Phase 2
Completed NCT03772171 - Estimate for Dietary Intakes and Hemodialysis Patients
Recruiting NCT02586402 - Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis Phase 2
Completed NCT01879618 - Use Of Fragmin In Hemodialysis Phase 3
Not yet recruiting NCT01346215 - Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure Phase 3
Completed NCT01220843 - FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease Phase 3
Completed NCT01111630 - Study of Erythropoietin (EPO) Administration Schedule Phase 4
Completed NCT00742716 - Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease Phase 2
Completed NCT00598273 - Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis Phase 3
Completed NCT00597584 - Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis Phase 3