Brennand Catherine, von Wilamowitz-Moellendorff Alexander, Dunn Sarah, Wilkinson Jennifer, Chadwick Thomas, Ternent Laura, Oluboyede Yemi, Wood Ruth, Walton Katherine, Fader Mandy, N'Dow James, Abdel-Fattah Mohamed, McClurg Doreen, Little Paul, Hilton Paul, Timoney Anthony, Morris Nicola, Thiruchelvam Nikesh, Larcombe James, Harrison Simon, Armstrong Heather, McColl Elaine, Pickard Robert
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Institute of Health and Society, Baddiley Clark Building, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Trials. 2016 Jun 4;17(1):276. doi: 10.1186/s13063-016-1389-y.
Clean intermittent self-catheterisation is an important management option for people who cannot empty their bladder effectively. Recurrent urinary tract infections are common in these patients. Data from recent studies suggest that antibiotic prophylaxis may be beneficial in reducing infection risk, but the effectiveness of this intervention remains uncertain.
METHODS/DESIGN: This is a 52-site, patient randomised superiority trial set in routine care comparing an experimental strategy of once daily antibiotic prophylaxis for 12 months against a control strategy of no prophylaxis in people who carry out self-catheterisation and suffer recurrent urinary tract infections. The primary outcome is number of urinary tract infections during a 12-month treatment period. Both groups will otherwise receive usual care including on demand treatment courses of antibiotics for urinary tract infection. 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 analysis will follow intention-to-treat principles.
This trial was commissioned and funded by the United Kingdom National Health Service following prioritisation of the research question by the National Institute for Health and Care Excellence.
ISRCTN67145101 EUDRACT2013-002556-32. Registered on 25 October 2013.
清洁间歇性自我导尿是无法有效排空膀胱者的重要管理选择。复发性尿路感染在这些患者中很常见。近期研究数据表明，抗生素预防可能有助于降低感染风险，但这种干预措施的有效性仍不确定。
方法/设计：这是一项在常规护理环境中进行的多中心（52个地点）患者随机优效性试验，比较针对进行自我导尿且患有复发性尿路感染的患者，每日一次抗生素预防12个月的试验策略与不进行预防的对照策略。主要结局是12个月治疗期内的尿路感染次数。两组患者在其他方面均接受常规护理，包括根据需要进行尿路感染的抗生素治疗疗程。参与者及其临床医生不会对分配的干预措施设盲，但管理和分析试验数据的中心试验人员将尽可能不知道参与者的分配情况。分析将遵循意向性分析原则。
该试验由英国国家医疗服务体系委托并资助，此前该研究问题已被英国国家卫生与临床优化研究所列为优先事项。
ISRCTN67145101 EUDRACT2013 - 002556 - 32。于2013年10月25日注册。
