A placebo controlled randomized trial of long-term antibiotics to prevent recurrent urinary tract infection in children

A trial of long term cotrimoxazole compared to placebo to prevent recurrent urinary tract infection in children

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000470392

Acronym

PRIVENT

Enrollment

576

Registered

2005-08-17

Start date

1998-11-02

Completion date

2007-03-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a multi-centre, blinded placebo-controlled randomised trial of long-term antibiotics in children. Patients will be randomly allocated to either low dose cotrimoxazole or placebo and followed for 12 months. Randomisation will be performed centrally by the NHMRC Clinical Trials Centre with dynamic balancing of important confounders and stratified by vesicoureteric reflux. Treatment allocation will be concealed. A total of 780 participants will be drawn from children routinely given long-term antibiotics, either because of their age (infants), what is thought to be a predisposing abnormality (vesicoureteric reflux), or because of recurrent infections. Children will be monitored at 3, 6, 9 and 12 month clinics. The primary outcome is repeat symptomatic microbiologically proven urinary tract infection

Interventions

Low dose continuous, daily, cotrimoxazole for 12 months. Oral route. Dose is calculated by volume according to body weight; 2mg/kg of Trimethoprim and 10mg/kg sulphamethoxazole. This works out to be 0.25mL/kg of 200-40mg/5mL suspension. Dose is increased every 3 months to the nearest 0.5mL as the child grows. Children take medication once per day for 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 18 Years

Healthy volunteers

Inclusion criteria

Children <18 years, symptomatic microbiologically proven urinary tract infection

Exclusion criteria

Asymptomatic urinary tract infection, Non-recurrent urinary tract infection in children > 5 years, Bag urine sample, growth below threshold, not pure growth, predisposing causes; indwelling catheter, nosocomial infection, urological/nephrological disease (renal disese, pelviureteric obstruction, vesicoureteral obstruction, posterior urethral valves, renal tract malformations, renal calculi), neurological problems (spina bifida, spina cord injuries, neurogenic bladder, cerebral palsy) Glucose 6 phosphate dehydrogenase deficiency, sulphur allergy, non-resident of Australia

Outcome results