Antibiotic Prophylaxis in Children With Pyelonephritis

University of Alberta

Status and phase: Withdrawn; Phase 3

Conditions: Pyelonephritis

Treatments: Drug: placebo; Drug: Trimethoprim Sulfamethoxazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00752375

6545

Details and patient eligibility

About

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.

Sex: All

Ages: Under 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

A

Active Comparator group

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.

Treatment:

Drug: Trimethoprim Sulfamethoxazole

B

Placebo Comparator group

Description:

Eligible children will then be randomized to placebo.

Treatment:

Drug: placebo