Antibiotic treatment for intermittent bladder catheterisation: A randomised controlled trial of once daily prophylaxis (The AnTIC study) - Antibiotic prophylaxis for clean intermittent catheterisation v1.0

The Newcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 404 人开始时间: 2013年8月29日最近更新: 2019年4月30日

试验速览

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•- 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, 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 297
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

•- 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). - Inability to take any one 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 complete trial documentation.

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