Trial | NCT00752375  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Feb 28
2009
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Jan 16
2015
Estimate

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

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.

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.

B Placebo Comparator

Eligible children will then be randomized to placebo.

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
No Results Posted