Antibiotic Treatment for Intermittent Bladder Catheterisation: A Randomised Controlled Trial of Once Daily Prophylaxis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Relative incidence of symptomatic antibiotic-treated UTI
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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
研究组 & 干预措施
Antibiotic prophylaxis
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.
干预措施: Nitrofurantoin or Trimethoprim or Cefalexin (Drug)
No prophylaxis
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.
干预措施: No prophylaxis (Other)
结局指标
主要结局
Relative incidence of symptomatic antibiotic-treated UTI
时间窗: 12 months
Relative incidence of symptomatic antibiotic-treated Urinary Tract Infection between the trial groups over 12 months
次要结局
未报告次要终点