Urinary Tract Infections, Recurrent Clinical Trial
Official title:
Antibiotic Treatment for Intermittent Bladder Catheterisation: A Randomised Controlled Trial of Once Daily Prophylaxis
This research project is designed to find out whether people who suffer repeated urinary
tract infections (UTI) related to the need to empty their bladders intermittently with a fine
plastic tube (catheter); a process called clean intermittent self-catheterisation (CISC),
benefit from taking continuous daily low-dose antibiotics (antibiotic prophylaxis). The
investigators estimate that about 40,000 people in the United Kingdom need to use CISC
regularly to empty their bladder either because of nerve damage such as multiple sclerosis or
because of failure of the bladder muscle to contract, and of these about 25% (10,000 people)
suffer frequent UTI. One way to reduce this problem may be to take a small daily dose of
antibiotics and the study aims to find out whether such treatment is effective and worthwhile
both for the people who suffer the problem and for the National Health Service (NHS).
The two options to be compared in the trial are firstly, a once daily preventive dose
(prophylaxis) of an antibiotic routinely used for this purpose (either nitrofurantoin or
trimethoprim or cefalexin), and secondly no prophylaxis. The investigators think that an
overall decrease of 20% or more in the frequency of UTI would be large enough for future
patients using CISC who get troublesome recurrent UTIs to be offered antibiotic prophylaxis
routinely. The investigators will also assess any harm caused by continuous use of
antibiotics, particularly side effects for those people taking them and changes in the
resistance of bacteria to these antibiotics. The investigators can then work out whether the
balance between the benefits and harms make the use of prophylaxis worthwhile to people
carrying out CISC and for the NHS as a whole.
The AnTIC trial is a 40-site, pragmatic, patient randomised superiority trial comparing an
experimental strategy of once daily antibiotic prophylaxis against a control strategy of no
prophylaxis. Both groups will otherwise receive usual care including on demand discrete
treatment courses of antibiotic treatment for UTI. The trial will be set in both primary and
secondary National Health Service (NHS) care. Participants and their clinicians will not be
blinded to the allocated intervention but central trial staff managing and analysing trial
data will, as far as possible, be unaware of participant allocation. The investigators will
also assess participant perception of benefit firstly by completion of a treatment
satisfaction questionnaire on exit and secondly by qualitative analysis of semi-structured
interviews on trial completion exploring the views and attitudes of a purposive sample of
participants towards the trial intervention. The primary economic analysis will assess the
cost per UTI avoided but we will also perform a cost-utility analysis and a contingent
valuation study. Bacterial ecological change will be assessed by comparing changes in
resistance patterns of E. coli in urine and perianal swabs. The investigators have formulated
a recruitment plan to progressively build to a target of 372 participants over 24 months.
The primary objective is to determine the relative clinical effectiveness and
cost-effectiveness of an experimental UTI prevention strategy of continuous once-daily
prophylactic antibiotic therapy against the control strategy of no prophylaxis in people
carrying out intermittent bladder catheterisation who suffer recurrent UTI. Outcomes will be
collected over 12 months for each participant and analysed at trial termination according to
intention to treat.
Primary objectives are:
- Determine the relative impact on incidence of UTI over 12 months
- Determine the incremental cost per symptomatic UTI avoided
Secondary objectives are:
- Clinical
- Determine the relative effect on quality of life (QoL) amongst trial participants
- Measure overall satisfaction with prophylactic antibiotic treatment
- Assess participants' perception of benefit at 12 months
- Record adverse effects related to both prophylaxis and treatment antibiotic use
- Determine relative rates of hospitalisation because of UTI
- Measure difference in estimated glomerular filtration rate (eGFR) at 12 months
- Determine rates of asymptomatic bacteriuria at 12 months
- Assess ecological change in E. coli isolated from urine and perianal swabs
- Economic
- Measure incremental cost per quality-adjusted life year (QALY) gained through
repeated completion of SF-36
- Assess participants' willingness to pay to avoid a UTI by contingent valuation at
end of trial participation and incorporate these data in the economic evaluation
using a cost-benefit framework.
The investigators will recruit from the population of adult users of CISC. The setting is NHS
hospitals and community sites throughout the UK where CISC use is taught and/or monitored.
The investigators expect to randomise at least 372 participants over a 24 month period. For
primary outcome purposes, follow up will continue for 12 months after intervention.
Participants will be consented separately to submit an additional urine sample and perianal
swab six months after trial completion (18-month timepoint) to assess return to baseline of
E. coli ecology. Separate consent will also be asked for permission to access clinical
records for extended follow up for a further nine years (ten years in total) and for
life-long linkage to central NHS databases. Allowing for a four-month analysis phase, the
total planned trial duration is 42 months.
;
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