Urinary Tract Infections, RecurrentPhase 4AnTICNCT02145338
Antibiotic Prophylaxis for Clean Intermittent Catheterisation
A Phase 4 study testing Nitrofurantoin or Trimethoprim or Cefalexin and No prophylaxis in people with Urinary Tract Infections, Recurrent, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Recurrent
- What is being tested?
- Nitrofurantoin or Trimethoprim or Cefalexin and No prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to 22 Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women aged ≥ 18 years
- Completed training of CISC and predicted to continue use for at least 12 months
- Able to give informed consent for participation in trial
- Able and willing to adhere to a 12-month follow up period
- Have either suffered at least two episodes of symptomatic UTI related to CISC within last 12 months.
- or at least one episode of UTI requiring hospitalization, or for those previously prescribed prophylactic antibiotic for UTI, have completed a 3-month washout period without antibiotic prophylaxis.
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- Able to take a once daily oral dose of at least one of nitrofurantoin, or trimethoprim, or cefalexin
- Intermittent catheterisation may be performed by participant, spouse, or carer
- No restriction on type of catheter used
Who cannot join
- Age < 18 years
- In learning phase of CISC
- Presence of symptomatic UTI - this will be treated and symptoms resolved prior to randomisation
- Already taking prophylactic antibiotic against UTI and declining 3-month washout period without antibiotic prophylaxis (this will be specifically monitored in the screening log)
- Inability to take any of the three prophylactic antibiotic agents due to multiple drug sensitivities
- Women who intend to become pregnant during planned period of trial participation or who are pregnant or who are breastfeeding
- Previous participation in this study
- Inability to give informed consent or have primary outcome information collected
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Cellular Medicine, Newcastle University
Newcastle upon Tyne, NE2 4HH
About this study
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.
Read the detailed description
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.
- Conditions
- Urinary Tract Infections, Recurrent
- Being tested
- Nitrofurantoin or Trimethoprim or Cefalexin, No prophylaxis
- Keywords
- Urinary tract infection, Clean intermittent self-catheterisation, Antibiotic prophylaxis
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrofurantoin or Trimethoprim or CefalexinDrug
Also called Macrodantin
Antibiotic prophylaxis
No prophylaxisOther
Discrete treatment courses of antibiotics as indicated by symptoms or signs of UTI.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic prophylaxis | Experimental | Nitrofurantoin or Trimethoprim or Cefalexin. Daily antibiotic prophylaxis: nitrofurantoin 50 mg (or 100 mg dependent on participant weight), or trimethoprim 100 mg, or cefalexin 250 mg. Receives: Drug: Nitrofurantoin or Trimethoprim or Cefalexin |
| No prophylaxis | Other | The control arm will be a strategy of no prophylaxis. Participants will self-monitor their symptoms as usual and report to their General Practitioner if they develop symptoms and signs suggestive of UTI requiring treatment. Receives: Other: No prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative incidence of symptomatic antibiotic-treated UTI
Relative incidence of symptomatic antibiotic-treated Urinary Tract Infection between the trial groups over 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startSep 2013
- Primary completion22 Feb 2017
- Study completion22 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme, Newcastle University, Glasgow Caledonian University, University of Aberdeen, Cambridge University Hospitals NHS Foundation Trust, North Bristol NHS Trust, University of Southampton
- Responsible party
- Sponsor
- Investigators
- Robert Pickard, MD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145338
- Sponsor's protocol ID
- AnTIC:6672
- Other IDs
- 2013-002556-32, 11-72-01
- Acronym
- AnTIC
- Status last verified
- Mar 2018
- First submitted
- 20 May 2014
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymised study data may be made available on request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment for Intermittent Bladder Catheterisation: A Randomised Controlled Trial of Once Daily Prophylaxis
- ClinicalTrials.gov ID
- NCT02145338
- Acronym / sponsor ID
- AnTIC / AnTIC:6672
- Conditions
- Urinary Tract Infections, Recurrent
- Keywords
- Urinary tract infection, Clean intermittent self-catheterisation, Antibiotic prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme, Newcastle University, Glasgow Caledonian University, University of Aberdeen, Cambridge University Hospitals NHS Foundation Trust, North Bristol NHS Trust, University of Southampton
- Study start
- Sep 2013 (actual)
- Primary completion
- 22 Feb 2017 (actual)
- Study completion
- 22 Feb 2017 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic prophylaxis | Experimental | Drug: Nitrofurantoin or Trimethoprim or CefalexinNitrofurantoin or Trimethoprim or Cefalexin. Daily antibiotic prophylaxis: nitrofurantoin 50 mg (or 100 mg dependent on participant weight), or trimethoprim 100 mg, or cefalexin 250 mg. |
| No prophylaxis | Other | Other: No prophylaxisThe control arm will be a strategy of no prophylaxis. Participants will self-monitor their symptoms as usual and report to their General Practitioner if they develop symptoms and signs suggestive of UTI requiring treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult men and women aged ≥ 18 years
- Completed training of CISC and predicted to continue use for at least 12 months
- Able to give informed consent for participation in trial
- Able and willing to adhere to a 12-month follow up period
- Have either suffered at least two episodes of symptomatic UTI related to CISC within last 12 months.
Key exclusion criteria (8 listed)
- Age < 18 years
- In learning phase of CISC
- Presence of symptomatic UTI - this will be treated and symptoms resolved prior to randomisation
- Already taking prophylactic antibiotic against UTI and declining 3-month washout period without antibiotic prophylaxis (this will be specifically monitored in the screening log)
- Inability to take any of the three prophylactic antibiotic agents due to multiple drug sensitivities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrofurantoin or Trimethoprim or CefalexinAlso: MacrodantinAntibiotic prophylaxis | Drug | Antibiotic prophylaxis |
| No prophylaxisDiscrete treatment courses of antibiotics as indicated by symptoms or signs of UTI. | Other | No prophylaxis |
Primary outcome
Relative incidence of symptomatic antibiotic-treated UTI
Time frame: 12 months
Relative incidence of symptomatic antibiotic-treated Urinary Tract Infection between the trial groups over 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised study data may be made available on request.
Related trials for Urinary Tract Infections, Recurrent
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Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
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VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Pickard, MD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrofurantoin or Trimethoprim or Cefalexin and No prophylaxis in people with Urinary Tract Infections, Recurrent, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative incidence of symptomatic antibiotic-treated UTI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.