Pyelonephritis
Conditions
Keywords
pyelonephritis, pediatric pyelonephritis, vesicoureteral reflux, DMSA scan
Brief 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.
Interventions
* 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.
DRUGplacebo
* 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.
Sponsors
Canadian Urological Association
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections. | one year |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether antibiotic prophylaxis prevents long-term renal scarring by assessing results of DMSA scans to look at long term renal scarring. | 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. | Yearly for five years |
Countries
Canada
Outcome results
None listed