drugset / Trial / NCT02021006

Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract

NCT02021006

RandomizedParallel-groupOpen-labelPrevention

Summary

The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.

Timeline

Start
2013-12
Primary completion
2020-01
Completion
2025-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 15 mg/kg
Comparator Cefixime Other / unclassified 2 mg/kg
Comparator Nitrofurantoin Unknown 1.5 mg/kg
Comparator Nitrofurantoin Unknown 2 mg/kg
Comparator Sulfamethoxazole Small molecule
Comparator Trimethoprim Small molecule 2.5 mg/kg
Comparator clavulanic acid Small molecule