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    Summary
    EudraCT Number:2013-002556-32
    Sponsor's Protocol Code Number:ANTIC:6672
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-002556-32
    A.3Full title of the trial
    Antibiotic treatment for intermittent bladder catheterisation: A randomised controlled trial of once daily prophylaxis (The AnTIC study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antiobiotic treatment for intermittent bladder catheterisation
    A.3.2Name or abbreviated title of the trial where available
    Antibiotic prophylaxis for clean intermittent catheterisation v1.0
    A.4.1Sponsor's protocol code numberANTIC:6672
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe Newcastle upon Tyne Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Health Technology Assessment Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewcastle University
    B.5.2Functional name of contact pointRobert Pickard
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Cellular Medicine, 3rd Floor William Leech Building, Medical School, Framlington Place
    B.5.3.2Town/ cityNewcastle upon Tyne
    B.5.3.3Post codeNE2 4HH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01912137139
    B.5.5Fax number01912137127
    B.5.6E-mailrobert.pickard@ncl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Generic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTrimethoprim
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Generic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNitrofurantoin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Generic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCefalexin
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent urinary tract infection in people who use intermittent bladder catheterisation.
    E.1.1.1Medical condition in easily understood language
    Repeated episodes of cystitis in people who have to use a catheter to empty their bladder.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064736
    E.1.2Term Antibiotic prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    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 at end of trial partic
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clincial outcome is the difference in incidence of symptomatic UTI during the 12-month observation period defined as the presence of at least one patient-reported or clinician-recorded symptom from a predefined list encompassing the recommendations of the British Infection Association (BIA), the Centres for Disease Control and Prevention (CDC) and spinal cord injury UTI consensus statement, together with taking a discrete treatment course of antibiotics prescribed by a clinician or as part of a patient-initiated self-start policy. The rate of UTI will be defined as the incident density rate; the number of UTI suffered during the observation period minus days spent taking treatment courses of antibiotics active against urinary tract organisms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months.
    E.5.2Secondary 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. Participants will complete the treatment satisfaction questionnaire for medication at 12 months as part of their completion of trial questionnaire. • Generic health-related quality of life. Participant completion of the SF-36 1-week recall questionnaire at baseline, 3, 6, 9 and 12 months and within the first 2 days of each episode of symptomatic antibiotic-treated UTI prompted by telephone, e mail or text message. Secondary health economic outcomes: • The main economic outcome is the incremental cost per urinary tract infection avoided. • Cost - utility analysis measuring the incremental cost per quality-adjusted life year (QALY) gained over 12 months derived from participant completion of the SF-36. • Cost - benefit analysis using partipant's willingness to pay to avoid a UTI measured by completion of the contingent valuation questionnaire at 12 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No prophylaxis
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned40
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject recruited to the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 297
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-08-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state372
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 372
    F.4.2.2In the whole clinical trial 372
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If the participant wishes and the clinician responsible for their routine care agrees, then the antibiotic prophylaxis can be continued beyond the 12-month trial participation period but without further active monitoring from the trial research team. ….
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-23
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