DURATION

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

BACKGROUND

UTIs are the most common bacterial infection seen in primary care and 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 GPs decide how many days of antibiotic treatment are necessary. We need to make sure that the antibiotics are taken for long enough to treat the infection, but avoid overtreating which increases the likelihood of bacteria becoming antibiotic resistant, which would mean that future UTis could be harder to treat.

The study aims to recruit 2,248 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 two commonly used antibiotics for this condition, then randomise them again to 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.

We hope that the findings of this study will influence prescribing guidelines nationally and internationally.

Who can participate?

Participants will be enrolled at participating GP practices in the United Kingdom when they present with symptoms of a suspected urinary tract infection (UTI). Adult women registered at a GP practice that is taking part in the study can participate if they are assigned female at birth, aged 18 years or above, and if the clinician determines that they require antibiotics for a suspected bladder (cystitis) or kidney (pyelonephritis) infection.

Trial Aims

This research aims to find the shortest antibiotic treatment duration needed to effectively treat urinary tract infections (UTIs) in women. We will also look at the impact of each antibiotic and treatment duration on antibiotic resistance in bacteria found in the patient’s urine.

Main Goal

Our main goal is to find out the shortest amount of time we need to give antibiotics to effectively treat UTIs. We will measure this by seeing how many study participants stay healthy without needing more medical help for their UTIs up to 42 days after treatment.

Alongside our main goal, we have several other objectives. We also want to see if different antibiotics and how long they are used for changes:

whether the UTI stays away up to 42 days after treatment;

any side effects related to these antibiotics;

the total amount of antibiotics used over 42 days;

the risk of the treatment not killing the bacteria and the bacteria becoming resistant to antibiotics;

how different antibiotics and treatment durations affect the health-related quality of life of patients, cost of treatment, and whether it's worth the cost.

We'll also ask some participants if they want to join two optional parts of the study:

In one part, we will look at how long antibiotics are used affects antibiotic resistance in bacteria in the gut.

In the other part, we'll ask patients what they think about different antibiotics and treatment lengths, and how this affects their behaviour related to the duration of antibiotic treatment.

How were patients and the public involved?

Nine women with repeated bladder and kidney infections were recruited to help develop the study proposal. They highlighted their uncertainty around the correct length of antibiotic courses and felt that we should focus on the proportion of women getting fully better because they were worried that shorter courses could result in ongoing symptoms or relapse. Our team includes a PPI representative who will join regular meetings as well as jointly leading our PPI work. A group of four women will help us develop trial materials, ensure the study process is acceptable, and will help us optimize recruitment and dissemination.