Antibiotic Prophylaxis in Children With Pyelonephritis

Study Overview
=================
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.

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

Conditions
-----------------
Pyelonephritis

Intervention / Treatment
-----------------
* Drug: Trimethoprim Sulfamethoxazole
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Eligible children will be randomized to antibiotic prophylaxis. Children under 3 months will receive amoxicillin 10mg/kg once per day. Children >3months will receive Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component). Those children with a Sulfa allergy will receive nitrofurantoin (1mg/kg) once per day. | Drug: Trimethoprim Sulfamethoxazole<br>* 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.<br>* Other names: Bactrim;|
| Placebo Comparator: B<br>Eligible children will then be randomized to placebo. | Drug: placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pyelonephritis, pediatric pyelonephritis, vesicoureteral reflux, DMSA scan