NCT00752375

Antibiotic Prophylaxis in Children With Pyelonephritis

A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Children who present with pyelonephritis undergo many investigations, and long term care to prevent renal damage. The focus is primarily on preventing renal failure however along the way and particularly with children, other issues arise which impact their lives, as well as their family's lives. Parents are concerned about subjecting their children to invasive procedures and long term antibiotic use, particularly if they are not sure of the benefit. This study seeks to provide information on the impact of investigation and long term antibiotic treatment in reference to long term health and quality of life in children who present with febrile urinary tract infections in the absence of anatomic abnormalities.

Conditions

• Pyelonephritis

Interventions

Type	Name	Description
DRUG	Trimethoprim Sulfamethoxazole	* Children \>3months of age will receive Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component)per day for one year. * Children under 3 months of age will receive amoxicillin 10mg/kg once per day for one year. * Those children with a Sulfa allergy will receive nitrofurantoin (1mg/kg) once per day for one year.
DRUG	placebo	* Placebo matching Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component)for children more than 3 months of age * Placebo matching amoxicillin 10mg/kg once per day for children under 3 months of age * Placebo matching nitrofurantoin (1mg/kg) once per day for children with a sulfa allergy.

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2008-09-15
• Last updated: 2015-01-16

Locations

1 site across 1 country: Canada