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Antibiotic Prophylaxis in Children With Pyelonephritis

Primary Purpose

Pyelonephritis

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Trimethoprim Sulfamethoxazole
placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyelonephritis focused on measuring pyelonephritis, pediatric pyelonephritis, vesicoureteral reflux, DMSA scan

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept 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).

Exclusion Criteria:

  • Neurogenic bladder
  • anatomic congenital anomaly
  • allergy to all prophylactic antibiotics
  • children whose parents do not wish to participate

Sites / Locations

  • Stollery Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

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.

Eligible children will then be randomized to placebo.

Outcomes

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.

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.
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.

Full Information

First Posted
September 11, 2008
Last Updated
January 14, 2015
Sponsor
University of Alberta
Collaborators
Canadian Urological Association
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1. Study Identification

Unique Protocol Identification Number
NCT00752375
Brief Title
Antibiotic Prophylaxis in Children With Pyelonephritis
Official Title
A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No participants
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Canadian Urological Association

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyelonephritis
Keywords
pyelonephritis, pediatric pyelonephritis, vesicoureteral reflux, DMSA scan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Eligible children will then be randomized to placebo.
Intervention Type
Drug
Intervention Name(s)
Trimethoprim Sulfamethoxazole
Other Intervention Name(s)
Septa, Bactrim
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To determine whether antibiotic prophylaxis prevents long-term renal scarring by assessing results of DMSA scans to look at long term renal scarring.
Time Frame
One year and five years
Title
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.
Time Frame
Yearly for five years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darcie Kiddoo, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

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Antibiotic Prophylaxis in Children With Pyelonephritis

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