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    Summary
    EudraCT Number:2022-000259-35
    Sponsor's Protocol Code Number:2020_03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-08
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2022-000259-35
    A.3Full title of the trial
    Assessment of the interest of a peri-operative antibiotic strategy applied to patients with asymptomatic bacteriuria undergoing intra-vesical botulinum toxin A injections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotic strategy and asymptomatic bacteriuria in the context of intra-vesical botulinum toxin A injections.
    A.3.2Name or abbreviated title of the trial where available
    AntibioBoNTA
    A.4.1Sponsor's protocol code number2020_03
    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 SponsorCentre Hospitalier Universitaire de Lille
    B.1.3.4CountryFrance
    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 supportDGOS, PHRC-19-0218
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namebotulinum toxin A
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 RoleComparator
    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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namebotulinum toxin A
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Overactive bladder (OAB) and/or detrusor overactivity (DO) in multiple sclerosis (MS)
    E.1.1.1Medical condition in easily understood language
    Sclérose en plaque ou lésion médullaire, traité par des injections intra-vésicales de toxine botulique A et utilisant l'auto-sondage propre intermittent comme mode mictionnel exclusif.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of “antibiotic saving strategy” compared to
    peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria (AB) among multiple sclerosis (MS) and spinal cord injured (SCI) patients undergoing clean intermittent self-catheterization (CISC).
    E.2.2Secondary objectives of the trial
    In the management of AB in the context of intra-vesical BoNTA injections, in MS and SCI patients undergoing CISC:

    - To compare between antibiotic saving strategy and peri-operative antibiotic strategy the others safety and efficacy outcomes.
    - To study the risk factors associated with post-injection symptomatic UTI.
    - To carry out an ad-hoc health-economic analysis aiming to compare current recommendations (peri-operative antibiotic strategy) with the “antibiotic saving strategy”.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Female and male over 18 years-old
    -MS or SCI (traumatic or non-traumatic)
    -Refractory OAB and/or DO (failure, intolerance or contra-indication to anti-muscarinic therapy)
    -Treated with intra-vesical botulinum toxin A injections having proved efficacy
    -CISC as the exclusive bladder management
    -AB on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical BoNTA injections)
    -Exclusion of morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI.
    E.4Principal exclusion criteria
    - Having already participated to the study
    - Augmentation cystoplasty
    - Bladder compliance disorders (<20 mL/cmH2O)
    - Ongoing cyclic antibiotic therapy
    - Ongoing corticosteroid therapy
    - Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion (MS patients)
    - Antibiotic therapy in the month before inclusion
    - Surgical procedure in the 3 months before and the 6 weeks following inclusion
    - Symptomatic UTI at the time of inclusion
    - Associated neurologic disease
    - Pregnancy or breast feeding
    - Individuals especially in need of protection
    - No informed consent
    - Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injections.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks following
    E.5.2Secondary end point(s)
    Safety:
    -Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.
    -Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.
    -Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.
    -Rate of patients with complication (other than symptomatic UTI) related to BoNTA injections occurring within the 6 weeks following the injections.
    -Rate of patients with complication not related to BoNTA injections occurring within the 6 weeks following the injections.
    -Rate of patients with admission to an emergency unit related to BoNTA injections occurring within the 6 weeks following the injections.
    -Rate of patients with admission to an emergency unit not related to BoNTA occurring within the 6 weeks following the injections.
    -Rate of patients with admission in a non-scheduled hospitalization related to BoNTA injections occurring within the 6 weeks following the injections.
    -Rate of patients with admission in a non-scheduled hospitalization not related to BoNTA injections occurring within the 6 weeks following the injections.

    Efficacy:
    -Maximal cystometric capacity (MCC) evaluated 6 weeks after BoNTA injections.
    -Rate of patients with DO (non-voiding detrusor contractions during feeling phase) evaluated 6 weeks after BoNTA injections.
    oIf DO: volume at the first uninhibited detrusor contraction
    oIf DO: maximal detrusor pressure
    -Number of CISC per day evaluated 6 weeks after BoNTA injections.
    -Number of urgency episodes evaluated 6 weeks after BoNTA injections.
    -Number of urinary incontinence episodes per day evaluated 6 weeks after BoNTA injections.
    -Functional bladder capacity evaluated 6 weeks after BoNTA injections.

    Risk factors associated with post-operative symptomatic UTI:
    -Diabetes mellitus
    -History of recurrent symptomatic UTI in the year preceding inclusion
    -History of false passage or urethrorrhagia in the year preceding inclusion
    -Type of catheter used for CISC (hydrophilic vs non-hydrophylic)
    -Frequency of CISC in the 3 days following BoNTA injections
    -Daily diuresis in the 3 days following BoNTA injections
    -Functional bladder capacity in the 3 days following BoNTA injections
    -Duration of the disease (MS or SCI)
    -ASIA score (SCI patients)
    -EDSS (MS patients)
    -Type of MS (MS patients)
    -Type of background immunosuppressive or immunomodulatory therapy (MS patients)
    -Gender
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned12
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months29
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 226
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state526
    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)
    No change from the normal treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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