Antiobiotic treatment for intermittent bladder catheterisatio

Phase 1

• Conditions: Recurrent urinary tract infection in people who use intermittent bladder catheterisation.; MedDRA version: 14.1 Level: PT Classification code 10064736 Term: Antibiotic prophylaxis System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002556-32-GB
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-29
• Study Completion: 2017-02-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 404

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified