Antibiotic Prophylaxis for Clean Intermittent Catheterisation

NCT02145338 | Completed Phase 4 DMC

• 3 other identifiers: AnTIC:66722013-002556-3211-72-01
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections, Recurrent

Keywords

Urinary tract infection; Clean intermittent self-catheterisation; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Relative incidence of symptomatic antibiotic-treated UTI

  Relative incidence of symptomatic antibiotic-treated Urinary Tract Infection between the trial groups over 12 months

  12 months

Study Arms (2)

Antibiotic prophylaxis

EXPERIMENTAL

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.

Drug: Nitrofurantoin or Trimethoprim or Cefalexin

No prophylaxis

OTHER

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.

Other: No prophylaxis

Interventions

Nitrofurantoin or Trimethoprim or Cefalexin DRUG

Antibiotic prophylaxis

Also known as: Macrodantin

Antibiotic prophylaxis

No prophylaxis OTHER

Discrete treatment courses of antibiotics as indicated by symptoms or signs of UTI.

No prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• NHS Health Technology Assessment Programme: collaborator
• Newcastle University: collaborator
• Glasgow Caledonian University: collaborator
• University of Aberdeen: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• North Bristol NHS Trust: collaborator
• University of Southampton: collaborator

Study Sites (1)

Institute of Cellular Medicine, Newcastle University

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

Related Links

• Trial Website

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Nitrofurantoin; Trimethoprim; Cephalexin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert Pickard, MD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: September 1, 2013
• Primary Completion: February 22, 2017
• Study Completion: February 22, 2017
• Last Updated: March 30, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: These will be published on the NIHR Journals Library in August 2018
• Access Criteria: All data requests should be submitted to the Chief Investigator for consideration. Access to anonymised data may be granted following review.

Locations

GB (1)