Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02145338
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2014-05-20
Brief Title:
Antibiotic Prophylaxis for Clean Intermittent Catheterisation
Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Organization:
Newcastle-upon-Tyne Hospitals NHS Trust
Study Overview
Official Title:
Antibiotic Treatment for Intermittent Bladder Catheterisation A Randomised Controlled Trial of Once Daily Prophylaxis
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AnTIC
Brief 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 antibiotics antibiotic prophylaxis The investigators estimate that about 40000 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 10000 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 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-002556-32 | EUDRACT_NUMBER | None | None |
| 11-72-01 | OTHER_GRANT | NIHR HTA | None |