Antibiotic Prophylaxis in Children With Pyelonephritis
Information source: University of Alberta
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pyelonephritis
Intervention: Trimethoprim Sulfamethoxazole (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Alberta Official(s) and/or principal investigator(s):
Darcie Kiddoo, MD, Principal Investigator, Affiliation: University of Alberta
Overall contact:
Darcie Kiddoo, MD, Phone: (780) 407-7808, Email: Darcie.Kiddoo@albertahealthservices.ca
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.
Clinical Details
Official title: A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Darcie Kiddoo, MD, Phone: (780) 407-7808, Email: Darcie.Kiddoo@albertahealthservices.ca
Stollery Children's Hospital, Edmonton, Alberta T6G 2B7, Canada; Recruiting
Darcie Kiddoo, MD, Principal Investigator
Maury Pinsk, MD, Sub-Investigator
Conor Maguire, MD, Sub-Investigator
Additional Information
Starting date: February 2009
Ending date: December 2018
Last updated: October 1, 2009
|
