Antibiotic Prophylaxis in Children With Pyelonephritis

Sponsor

University of Alberta (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00752375

Collaborator

Canadian Urological Association (Industry)

Enrollment

Location

Arms

69.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pyelonephritis	Drug: Trimethoprim Sulfamethoxazole Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A 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 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. Other Names: Septa Bactrim
Placebo Comparator: B Eligible children will then be randomized to placebo.	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.

Arm

Intervention/Treatment

Active Comparator: A

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

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.

Other Names:

Septa

Bactrim

Placebo Comparator: B

Eligible children will then be randomized to placebo.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).