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

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12608000470392
• Date of registration: 17/08/2005
• Primary sponsor: Hospital The Childrens Hospital at Westmead
• Public title: A placebo controlled randomized trial of long-term antibiotics to prevent recurrent urinary tract infection in children PRIVENT
• Scientific title: A trial of long term cotrimoxazole compared to placebo to prevent recurrent urinary tract infection in children
• Date of first enrolment: 1/12/1998
• Target sample size: 780
• Recruitment status: Closed: follow-up complete
• URL: http://www.anzctr.org.au/ACTRN12608000470392.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Australia

Contacts

• Name: Professor Jonathan Craig

• Name: Professor Jonathan Craig

Key inclusion & exclusion criteria

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

Age minimum: 0 Days
Age maximum: 18 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Urinary tract infection

Intervention(s)

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.

Primary Outcome(s)

Repeat symptomatic microbiologically proven urinary tract infection. Measured by direct questioning of parents at 3, 6, 9 and 12 month clinic reviews. Any parent stating yes to a urinary tract infection is asked for consent to contact primary care giver and obtain details. Trial coordinators at each centre contact health providers and obtain a copy of microbioligucal report on the urine culture.

Secondary Outcome(s)

Abnorrmalities on dimercaptosuccinic acid scan (DMSA). Children with abnormal initial DMSA scans are requested to undergo a repeat DMSA at 12 months. All DMSA scans are centrally re-reported by one Senior Staff Specialist in nuclear medicine at The Children's Hospital at Westmead (CHW). DMSA scans at 12 months are compared to initial scans and the single CHW reviewer codes the scans as to whether they are ; unchanged, partial improvement, complete improvement and no change.

Adverse drug reactions. Measured by direct questioning of parent at 3,6,9 and 12 month time points. Questioned about occurrences of; diarrhoea, nausea, vomitting, rash, thrush, jaundice, anaphylaxis, haematoligic abnormalities

Antibiotic administration for other infectious disease. Measured by direct questioning of parents at 3, 6, 9 and 12 month clinic reviews

Febrile urinary tract infection. Measured by direct questioning of parent at 3,6,9 and 12 month time points and verified with appropriate health care providers record of microbiological result

Hospitalisation. Measured by direct questioning of parent at 3,6,9 and 12 month time points

Source(s) of Monetary Support

Financial Markets Foundation of Australia

JT Honan, Manildra Holdings

National Health and Medical Research Council (NHMRC) of Australia

Secondary Sponsor(s)

University of Sydney