ANtibiotic Treatment for Intermittent bladder Catheterisation: a randomised controlled trial of once daily prophylaxis (the AnTIC study)

ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 372 人开始时间: 2013年10月25日最近更新: 2019年9月9日

适应症

试验速览

•1. Adult men and women aged = 18 years
•2. Completed training of CISC and predicted to continue use for at least 12 months
•3. Able to give informed consent for participation in trial
•4. Able and willing to adhere to a 12-month follow-up period
•5. Have either suffered at least two episodes of symptomatic UTI related to CISC within the last 12 months or, for those previously prescribed prophylactic antibiotics for UTI, have completed a 3-month washout period without antibiotic prophylaxis
•6. Able to take a once daily oral dose of at least one of nitrofurantoin, trimethoprim or cefalexin
•7. Intermittent catheterisation may be performed by participant, spouse or carer
•8. No restriction on type of catheter used

•1. Age < 18 years
•2. In learning phase of CISC
•3. Presence of symptomatic UTI; this will be treated and symptoms resolved prior to randomisation
•4. Already taking prophylactic antibiotics against UTI and declining 3-month washout period without antibiotic prophylaxis (this will be specifically monitored)
•5. Inability to take any one of the three prophylactic antibiotic agents due to multiple drug sensitivities
•6. Women who intend to become pregnant during planned period of trial participation or who are pregnant or who are breastfeeding
•7. Previous participation in this study
•8. Inability to give informed consent or complete trial documentation

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)