Antibiotic Prophylaxis in Children With Pyelonephritis

University of Alberta

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Pyelonephritis

Interventions

Trimethoprim SulfamethoxazoleDRUG

* 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.

placeboDRUG

* 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.

Eligibility

Sex: ALLMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children 0 to 12 years of age presenting with first episode of acute pyelonephritis in the absence of vesicoureteral reflux. * Acute pyelonephritis defined as presence of fever, a positive urine culture (growth of a single urinary tract pathogen at =10(8) CFU/ml for catheterization specimens and =10(4) CFU/ml for clean catch specimens), and a positive DMSA scan (a discreet defect or generalized decrease in activity). Exclusion Criteria: * Neurogenic bladder * anatomic congenital anomaly * allergy to all prophylactic antibiotics * children whose parents do not wish to participate

Locations (1)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections.

Time frame: one year

Secondary Outcomes

To determine whether antibiotic prophylaxis prevents long-term renal scarring by assessing results of DMSA scans to look at long term renal scarring.

Time frame: One year and five years

To determine whether recurrent infections and involvement with the medical system impacts quality of life by assessing how this medical condition affects children using standardized quality of life questionnaires.

Time frame: Yearly for five years

Data from ClinicalTrials.gov

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