Antibiotic Prophylaxis in Children With Pyelonephritis | NCT00752375 | Trialant

Antibiotic Prophylaxis in Children With Pyelonephritis | NCT00752375 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	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
B	Placebo Comparator	Eligible children will then be randomized to placebo.	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trimethoprim Sulfamethoxazole	Drug	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

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