Antiobiotic treatment for intermittent bladder catheterisation

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002556-32-GB

Enrollment

372

Registered

2013-08-29

Start date

2013-09-05

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Generic Product Name: Trimethoprim Pharmaceutical Form: Capsule, hard Trade Name: Generic Product Name: Nitrofurantoin

Eligibility

Sex/Gender

All

Inclusion 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, 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The principal research question is to determine whether use of antibiotic prophylaxis over 12 months results in a clinically significant (real and worthwhile) reduction in the rate of symptomatic, antibiotic-treated urinary tract infection suffered by people performing intermittent self-bladder catheterisation compared to no prophylaxis. We will also calculate which treatment strategy gives best value for money to patients and the NHS by measuring the cost per urinary infection avoided by use of antibiotic prophylaxis. During the first 12 months of the trial we will determine whether recruitment to planned trial duration and sample size is going to succeed by monitoring numbers of randomised participants. Specific objectives for this first phase of the study are to find out how quickly individual research sites can begin to recruit patients to the trial, to find out how many eligible patients are identified and how many of those agree to participate per month, and to monitor whether;Secondary Objective: Secondary objectives during the full trial phase are: Clinical - Determine the relative effect on quality of life (QoL) amongst trial participants. - Measure overall satisfaction with prophylactic antibiotic treatment. - Assess participants’ perception of benefit at 12 months. - Record adverse effects related to both prophylaxis and no prophylaxis antibiotic treatment strategies. - Determine relative rates of need to be admitted to hospital because of urinary infection. - Measure any change in kidney function at 12 months. - Determine rates of asymptomatic bacteriuria (bacteria in urine without symptoms of infection) at 12 months. - Assess change in antibiotic resistance patterns of the commonest bacterium, Escherichia coli, isolated from urine and perianal swabs. Economic - Calculate the financial cost of any benefit in quality of life. - Assess participants’ willingness to pay to avoid a UTI by a questionnaire technique called contingent valuation	—

Measure

Time frame

Main Objective: The principal research question is to determine whether use of antibiotic prophylaxis over 12 months results in a clinically significant (real and worthwhile) reduction in the rate of symptomatic, antibiotic-treated urinary tract infection suffered by people performing intermittent self-bladder catheterisation compared to no prophylaxis. We will also calculate which treatment strategy gives best value for money to patients and the NHS by measuring the cost per urinary infection avoided by use of antibiotic prophylaxis. During the first 12 months of the trial we will determine whether recruitment to planned trial duration and sample size is going to succeed by monitoring numbers of randomised participants. Specific objectives for this first phase of the study are to find out how quickly individual research sites can begin to recruit patients to the trial, to find out how many eligible patients are identified and how many of those agree to participate per month, and to monitor whether;Secondary Objective: Secondary objectives during the full trial phase are: Clinical - Determine the relative effect on quality of life (QoL) amongst trial participants. - Measure overall satisfaction with prophylactic antibiotic treatment. - Assess participants’ perception of benefit at 12 months. - Record adverse effects related to both prophylaxis and no prophylaxis antibiotic treatment strategies. - Determine relative rates of need to be admitted to hospital because of urinary infection. - Measure any change in kidney function at 12 months. - Determine rates of asymptomatic bacteriuria (bacteria in urine without symptoms of infection) at 12 months. - Assess change in antibiotic resistance patterns of the commonest bacterium, Escherichia coli, isolated from urine and perianal swabs. Economic - Calculate the financial cost of any benefit in quality of life. - Assess participants’ willingness to pay to avoid a UTI by a questionnaire technique called contingent valuation

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Secondary

Measure	Time frame
Secondary end point(s): Secondary clinical outcome measures: • Febrile UTI defined as the primary outcome + presence of a recorded fever of more than 38 C. Confirmed by inspection of primary or secondary healthcare record by research staff. • Microbiologically-confirmed symptomatic UTI defined as the primary outcome + positive urine culture. Participants will provide a intermittent catheter specimen of urine (CSU) for local analysis as requested by the treating clinician. This will be analysed according to clinician decision by the local microbiology using local SOP. We will also ask the participant to send an CSU to the central microbiology laboratory in Newcastle upon Tyne each time they consider they have symptoms suggestive of UTI and intend to commence a treatment course of antibiotic. This will be analysed and cultured on receipt in the central laboratory and the result used for outcome purposes but not for routine care. • Antibiotic prescription for asymptomatic UTI without participant-reported or clinician recoded evidence of symptom change. • Asymptomatic bacteriuria defined as a positive urine culture in the absence of symptoms. Participants will be asked to provide a CSU sent to the central laboratory in provided packaging at baseline prior to randomisation and during asymptomatic periods in months 3, 6, 9 and 12 of their trial participation. They will also be separately consented to provide a CSU six months after completion of trial (18-month timepoint). • Hospitalisation due to UTI defined as an unplanned visit to hospital for treatment of a UTI which required at least one overnight stay in hospital. Collected from healthcare record review and checked from participant report or enquiry. • Participant perception of benefit. We will record and analyse semi-structured interviews with up to 30 participants purposively sampled from both trial arms on completion of their 12-month trial period. • Overall satisfaction with allocated treatment strategy	—

Measure

Time frame

Secondary end point(s): Secondary clinical outcome measures: • Febrile UTI defined as the primary outcome + presence of a recorded fever of more than 38 C. Confirmed by inspection of primary or secondary healthcare record by research staff. • Microbiologically-confirmed symptomatic UTI defined as the primary outcome + positive urine culture. Participants will provide a intermittent catheter specimen of urine (CSU) for local analysis as requested by the treating clinician. This will be analysed according to clinician decision by the local microbiology using local SOP. We will also ask the participant to send an CSU to the central microbiology laboratory in Newcastle upon Tyne each time they consider they have symptoms suggestive of UTI and intend to commence a treatment course of antibiotic. This will be analysed and cultured on receipt in the central laboratory and the result used for outcome purposes but not for routine care. • Antibiotic prescription for asymptomatic UTI without participant-reported or clinician recoded evidence of symptom change. • Asymptomatic bacteriuria defined as a positive urine culture in the absence of symptoms. Participants will be asked to provide a CSU sent to the central laboratory in provided packaging at baseline prior to randomisation and during asymptomatic periods in months 3, 6, 9 and 12 of their trial participation. They will also be separately consented to provide a CSU six months after completion of trial (18-month timepoint). • Hospitalisation due to UTI defined as an unplanned visit to hospital for treatment of a UTI which required at least one overnight stay in hospital. Collected from healthcare record review and checked from participant report or enquiry. • Participant perception of benefit. We will record and analyse semi-structured interviews with up to 30 participants purposively sampled from both trial arms on completion of their 12-month trial period. • Overall satisfaction with allocated treatment strategy

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Countries

United Kingdom

Contacts

Public ContactRobert Pickard

Newcastle University

robert.pickard@ncl.ac.uk01912137139

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 13, 2026