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
Trial acronym: DURATION-UTI
Description
UTIs are among the most common presumed bacterial infections treated with antibiotics and are far more common in women than men. Over four million prescriptions for UTIs are issued to women in the UK every year. However, there is little evidence to help clinicians decide how many days of antibiotic treatment are necessary. We need to use the shortest treatment duration which ensures that the infection is properly treated. This could reduce the risk of bacteria becoming antibiotic resistant, and help ensure the antibiotics remain effective for treating UTIs in the future.
This research aims to find the shortest antibiotic treatment duration needed to treat urinary tract infections (UTIs) in women effectively. We will also look at the impact of each antibiotic and treatment duration on antibiotic resistance in bacteria found in the patient’s urine.
The study aims to recruit 2248 adult women with UTI symptoms who visit a clinician in either a hospital or GP surgery, and for whom the clinician judges that antibiotics are needed for a suspected bladder (cystitis) or kidney (pyelonephritis) infection.
The clinician will randomise women with cystitis to receive one of 2 commonly used antibiotics for this condition, then randomised again to take their antibiotic treatment for one of five different treatment durations. Women with pyelonephritis will be offered one of a family of antibiotics which work in similar ways depending on the local prescribing policy and will be randomised to take their antibiotic treatment for one of six different treatment durations.
Primary Care Clinical Trials Unit (PC-CTU) are the lead CTU and will also oversee the recruitment in primary care. Brighton and Sussex Clinical Trial Unit (BSCTU) with Prof Martin Llewelyn will oversee recruitment in secondary care sites. Secondary care sites will only participate in the pyelonephritis sub trial.
Study design: Open-label, parallel group, multi-arm “durations” randomised trial with two sub-trials 1) cystitis and 2) pyelonephritis.
Disease area: Infection
Trial status: Recruiting
Chief Investigator: Prof Gail Hayward, and Prof Martin Llewelyn (Co-Chief Investigators)
Sponsor: University of Oxford
Funder: National Institute for Health Research (NIHR)
Start date: December 2023
End date: July 2025
Recruitment target: 2248 (Pyelonephritis sub trial = 738)
Summary of study results: N/A
For further information contact: Email: duration@bsctu.ac.uk