Antibiotic Prophylaxis in Children With Pyelonephritis

NCT00752375 | Withdrawn Phase 3

• 1 other identifier: 6545
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyelonephritis

Keywords

pyelonephritis; pediatric pyelonephritis; vesicoureteral reflux; DMSA scan

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (2)

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

  One year and five years

• 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.

  Yearly for five years

Study Arms (2)

A

ACTIVE COMPARATOR

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

B

PLACEBO COMPARATOR

Eligible children will then be randomized to placebo.

Drug: placebo

Interventions

Trimethoprim Sulfamethoxazole DRUG

* 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.

Also known as: Septa, Bactrim

A

placebo DRUG

* 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.

B

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Urological Association: collaborator

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Pyelonephritis; Vesico-Ureteral Reflux

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; bacitracin zinc, neomycin sulfate, polymyxin B, drug combination

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Darcie Kiddoo, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

CA (1)