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Antibiotic Prophylaxis for Clean Intermittent Catheterisation (AnTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02145338
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : March 30, 2018
Sponsor:
Collaborators:
NHS Health Technology Assessment Programme
Newcastle University
Glasgow Caledonian University
University of Aberdeen
Cambridge University Hospitals NHS Foundation Trust
North Bristol NHS Trust
University of Southampton
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infections, Recurrent Drug: Nitrofurantoin or Trimethoprim or Cefalexin Other: No prophylaxis Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antibiotic Treatment for Intermittent Bladder Catheterisation: A Randomised Controlled Trial of Once Daily Prophylaxis
Actual Study Start Date : September 2013
Actual Primary Completion Date : February 22, 2017
Actual Study Completion Date : February 22, 2017


Arm Intervention/treatment
Experimental: Antibiotic prophylaxis
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
Antibiotic prophylaxis
Other Name: Macrodantin

No prophylaxis
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
Discrete treatment courses of antibiotics as indicated by symptoms or signs of UTI.




Primary Outcome Measures :
  1. Relative incidence of symptomatic antibiotic-treated UTI [ Time Frame: 12 months ]
    Relative incidence of symptomatic antibiotic-treated Urinary Tract Infection between the trial groups over 12 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145338


Locations
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United Kingdom
Institute of Cellular Medicine, Newcastle University
Newcastle upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
NHS Health Technology Assessment Programme
Newcastle University
Glasgow Caledonian University
University of Aberdeen
Cambridge University Hospitals NHS Foundation Trust
North Bristol NHS Trust
University of Southampton
Investigators
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Principal Investigator: Robert Pickard, MD Newcastle University
Additional Information:
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02145338    
Other Study ID Numbers: AnTIC:6672
2013-002556-32 ( EudraCT Number )
11-72-01 ( Other Grant/Funding Number: NIHR HTA )
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised study data may be made available on request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Urinary tract infection
Clean intermittent self-catheterisation
Antibiotic prophylaxis
Additional relevant MeSH terms:
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Urinary Tract Infections
Reinfection
Infections
Urologic Diseases
Recurrence
Disease Attributes
Pathologic Processes
Trimethoprim
Nitrofurantoin
Cephalexin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents