Antibiotic Prophylaxis in Children With Pyelonephritis - Full Text View

Sponsor:	University of Alberta
Collaborator:	Canadian Urological Association
Information provided by (Responsible Party):	Darcie Kiddoo, University of Alberta
ClinicalTrials.gov Identifier:	NCT00752375

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 III

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:

MedlinePlus related topics: Antibiotics GERD Urinary Tract Infections

Drug Information available for: Nitrofurantoin Nitrofurantoin monohydrate Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

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

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:	September 28, 2011
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
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Urinary Bladder Diseases
Anti-Bacterial Agents
Nitrofurantoin
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination

Sulfamethoxazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012