Antibiotic Prophylaxis in Children With Pyelonephritis

NCT ID: NCT00752375

Last Updated: 2015-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Trimethoprim Sulfamethoxazole

Intervention Type: 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.

B

Eligible children will then be randomized to placebo.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Septa; Bactrim

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

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Urological Association

INDUSTRY

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Darcie Kiddoo

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darcie Kiddoo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Stollery Children's Hospital

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

6545

Identifier Type: -

Identifier Source: org_study_id