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Trial record 1 of 19 for:    Open Studies | "Pyelonephritis"
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Antibiotic Prophylaxis in Children With Pyelonephritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by University of Alberta
Sponsor:
Collaborator:
Canadian Urological Association
Information provided by (Responsible Party):
Darcie Kiddoo, University of Alberta
ClinicalTrials.gov Identifier:
NCT00752375
First received: September 11, 2008
Last updated: October 10, 2012
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Pyelonephritis
Drug: Trimethoprim Sulfamethoxazole
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]

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. [ Time Frame: One year and five years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: February 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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
  • 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
Placebo Comparator: B
Eligible children will then be randomized to placebo.
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.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752375

Contacts
Contact: Darcie Kiddoo, MD (780) 407-7808 Darcie.Kiddoo@albertahealthservices.ca

Locations
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Principal Investigator: Darcie Kiddoo, MD         
Sub-Investigator: Maury Pinsk, MD         
Sub-Investigator: Conor Maguire, MD         
Sponsors and Collaborators
University of Alberta
Canadian Urological Association
Investigators
Principal Investigator: Darcie Kiddoo, MD University of Alberta
  More Information

No publications provided

Responsible Party: Darcie Kiddoo, Physician, University of Alberta
ClinicalTrials.gov Identifier: NCT00752375     History of Changes
Other Study ID Numbers: 6545
Study First Received: September 11, 2008
Last Updated: October 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
pyelonephritis
pediatric pyelonephritis
vesicoureteral reflux
DMSA scan

Additional relevant MeSH terms:
Pyelonephritis
Vesico-Ureteral Reflux
Kidney Diseases
Nephritis
Nephritis, Interstitial
Pyelitis
Urinary Bladder Diseases
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Nitrofurantoin
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014