Antibiotic Prophylaxis for Clean Intermittent Catheterisation (AnTIC)
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|ClinicalTrials.gov Identifier: NCT02145338|
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : March 30, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
Other Name: Macrodantin
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.
- 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
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
|Institute of Cellular Medicine, Newcastle University|
|Newcastle upon Tyne, United Kingdom, NE2 4HH|
|Principal Investigator:||Robert Pickard, MD||Newcastle University|