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Antibiotic Prophylaxis in Children With Pyelonephritis

Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pyelonephritis

Intervention: Trimethoprim Sulfamethoxazole (Drug); placebo (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: University of Alberta

Official(s) and/or principal investigator(s):
Darcie Kiddoo, MD, Principal Investigator, Affiliation: University of Alberta


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections.

Secondary outcome:

To determine whether antibiotic prophylaxis prevents long-term renal scarring by assessing results of DMSA scans to look at long term renal scarring.

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.


Minimum age: N/A. Maximum age: 12 Years. Gender(s): Both.


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

Locations and Contacts

Stollery Children's Hospital, Edmonton, Alberta T6G 2B7, Canada
Additional Information

Starting date: February 2009
Last updated: January 14, 2015

Page last updated: August 23, 2015

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