Impact of duration of antibiotic therapy on effectiveness, safety and selection of antibiotic resistance in adult women with urinary tract infections (UTI): a randomised controlled trial. (DURATION-UTI)

Research summary

Principal question of the study. This research aims to find the shortest antibiotic treatment duration needed to treat urinary tract infections (UTIs) effectively. We will also look at the impact of each antibiotic and treatment duration on antibiotic resistance in bacteria found in the urine. Design and methods This will be an open-label,parallel group,multi-arm randomised trial with two sub-trials enrolling patients with: 1) cystitis,and 2) pyelonephritis. Participants with cystitis will be recruited only from primary care. Participants with pyelonephritis will be recruited from primary and secondary care. It uses a novel trial design called ‘durations’,in which participants are randomised to one of a range of antibiotic treatment durations rather than just a comparison of two pre-specified durations. This allows a duration-of-treatment: response curve to be constructed overcoming several major limitations of conventional non-inferiority trial designs in antibiotic research. We will be evaluating the optimal treatment duration for adult women for the following treatments and conditions: • Nitrofurantoin for uncomplicated cystitis • Pivmecillinam for uncomplicated cystitis • Beta-lactams for uncomplicated pyelonephritis. Within each of these three treatment-condition combinations the primary aim will be to investigate the minimum duration of antibiotic therapy that provides an acceptable level of clinically sustained cure at day 42. Data will be collected at baseline and up to and including 42-days post-randomisation via urine samples,self-completed questionnaires,and medical notes review. There will be additional data collection at 6 months post randomisation for health economics outcomes.

Principal Investigator

Dr Nicola Jones

Contact us

Email: sally.beer@ouh.nhs.uk

IRAS number

1006965