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Contact Information:

Dr . DURATION UTI Team
+44 (0)1865 617949
duration@phc.ox.ac.uk


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Be Part of Research - Trial Details - Impact of duration of antibiotic treatment on the effectiveness, safety and selection of antibiotic resistance in adult women with urinary tract infections (UTI): a randomised controlled trial.
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Impact of duration of antibiotic treatment on the effectiveness, safety and selection of antibiotic resistance in adult women with urinary tract infections (UTI): a randomised controlled trial.

Recruiting

Open to: Female

Age: Adult

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Medical Conditions

Urinary tract infections (UTI), cystitis, pyelonephritis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This research aims to find the shortest antibiotic treatment duration needed to treat urinary tract infections (UTIs) effectively. We will look at the impact of each antibiotic and treatment duration on antibiotic resistance.
UTIs, both bladder and kidney infections, are among the most common infections treated with antibiotics. 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 avoid bacteria becoming antibiotic resistant, ensuring antibiotics remain effective.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Jul 2023 31 Jan 2025

The clinician will randomise women with bladder infection to receive one of two commonly used antibiotics for this condition. Women with kidney infection will be offered one of a family of antibiotics which will work in similar ways depending on the local prescribing policy. Because we don’t know for how many days women should take a particular antibiotic to get the best results from treatment, we will randomise women to take their antibiotic treatment for one of five or six different treatment durations in days. Our main focus will be to compare how many women have got fully better 6 weeks after starting antibiotics. We will also measure how long each woman experiences UTI symptoms, whether the bacteria in their urine are killed by the antibiotic, whether they develop further UTIs, and the value for money of each treatment duration.
We will invite women who join the main study to take part in an optional rectal swab sub-study about the effect of antibiotic duration on antibiotic resistance in bacteria in their gut.


We will recruit 2,248 adult women with UTI symptoms for whom the doctor judges that antibiotics are needed for a suspected bladder or kidney infection. We will include women with symptoms of bladder and kidney infections.

You can take part if:



You may not be able to take part if:


1. Antibiotics for the prevention or treatment of UTI within the previous month (n.b. Pyelonephritis patients that have started antibiotics within 48 hours are included).2. Previous participation in the DURATION UTI Trial3. Indwelling catheter 4. Inclusion in the trial is inappropriate in the judgement of the responsible clinician5. Known anatomical abnormality of the urinary tract6. Neurogenic bladder7. Known pregnancy (pregnancy test not required for participation)8. Unable to comply with study procedures9. All antibiotic agents available to the participant in the trial are precluded in the view of the responsible clinician for example by:9.1. patient factors (such as allergy, degree of renal impairment)9.2. antibiotic susceptibility results (e.g. known carrier of antibiotic resistant organisms or resistance profile of the current infection if known at randomisation).


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Benefits:
Although we do not anticipate an immediate benefit to participants, in the longer term understanding how many days of antibiotics should be prescribed for their UTI will benefit patients by avoiding unnecessary antibiotic side effects and reducing the risk of antibiotic resistance.
Risks:
Time will be needed for collection of research data from the trial participants collected by the questionnaires the participants complete; We are keeping all questions to a necessary minimum to reduce the burden as much as possible. The participants may incur an expense during purchase of the prescribed antibiotics. A £20 voucher will be provided to all participants to reimburse them for their input into the study. Those taking part in the qualitative sub-study will also receive an additional £10 voucher to reimburse them for their time. We currently don’t know what the implications are of taking shorter or longer courses of antibiotics: shorter courses could result in an infection that s not fully treated, but longer courses could result in increased resistance to antibiotics.
The participant will be asked to supply urine samples to the trial team that are extra to those for clinical care, and also potential rectal swabs if they are part of the sub-study. These can be difficult to collect and they will have to post them. We will provide all materials they need for taking and posting the samples and will aim to make the process as straightforward as possible for them.

Dr . DURATION UTI Team
+44 (0)1865 617949
duration@phc.ox.ac.uk



The study is sponsored by University of Oxford and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN18390724

Or CPMS 56161

Last updated 14 March 2024

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