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    Summary
    EudraCT Number:2012-002430-36
    Sponsor's Protocol Code Number:AntibioTICS
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002430-36
    A.3Full title of the trial
    Multicentre, randomised, double-blinded, placebo-controlled trial of efficacy of amoxicilline/clavulanic acid in patients affected by tic disorder colonized by GAS. No-proft stidy.
    Multicenter, gerandomiseerd, dubbel-blind, placebo-gecontroleerde trial van de effictiviteit van amoxililline/clavulanic acid in patiënten met een tic stoornis gekoloniseerd met GAS. Non-profit studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre, randomised, double-blinded, placebo-controlled trial of efficacy of antibiotic therapy in patients affected by tic disorder and with group A streptococcal colonization, No-profit study.
    Multicenter, gerandomiseerd, dubbel-blind, placebo-gecontroleerde trial van de effictiviteit van antibiotica therapie in patiënten met een tic stoornis em met groep A streptokokken colonisatie. Non-profit studie.
    A.3.2Name or abbreviated title of the trial where available
    AntibioTICS
    AntibioTICS
    A.4.1Sponsor's protocol code numberAntibioTICS
    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 SponsorAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.1.3.4CountryItaly
    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 supportComunita' Europea
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSapienza Universita' di Roma
    B.5.2Functional name of contact pointDipartimento di Pediatria e NPI
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Sabelli 108
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00185
    B.5.3.4CountryItaly
    B.5.4Telephone number0644712288
    B.5.5Fax number0644712229
    B.5.6E-mailfrancesco.cardona@uniroma1.it
    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 AUGMENTIN*BB SOSP FL 140ML C/C
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOTASSIUM CLAVULANATE
    D.3.9.1CAS number 61177-45-5
    D.3.9.4EV Substance CodeSUB12232MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.4
    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
    D.8.3Pharmaceutical form of the placeboPowder and solvent for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic tic disorder
    Chronische tic stoornis
    E.1.1.1Medical condition in easily understood language
    Tic disorder
    Tic stoornis
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10043834
    E.1.2Term Tic disorder, unspecified
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Test the hypothesis that antibiotic treatment of GAS colonisation compared to placebo is associated with a larger reduction of tic and associated neuropsychiatric symptoms in the short-term (1 month) in patients with a tic disorder colonised by GAS.
    De hypothese testen dat antibiotica behandeling van GAS colonisatie vergeleken met placebo samen hangt met een grotere reductie van tic en aanverwante neuropsychiatrische symptomen op de korte termijn (1 maand) in patiënten met een tic stoornis met een GAS colonisatie.
    E.2.2Secondary objectives of the trial
    Test the hypothesis that antibiotic treatment of GAS colonisation is superior to placebo in the long-term (1 year) reduction of tic and associated neuropsychiatric symptoms in patients with a tic disorder colonized by GAS. Investigate the influence of possible moderators on treatment outcome. Investigate the effects of antibiotic treatment on patient’s immune responses to GAS antigens.
    De hypothese testen dat antibiotica behandeling van GAS colonisatie vergeleken met placebo superieur is op de lange termijn (1 jaar) en samen hangt met een grotere reductie van tic en aanverwante neuropsychiatrische symptomen in patiënten met een tic stoornis met een GAS colonisatie. De invloed van mogelijke moderatoren op behandelings uitkomsten onderzoeken. De invloed onderzoeken van de effecten van antibiotica behandeling op de immuun responsen op GAS antigenen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant and/or parents willing and able to give informed consent for participation in the study • Male or Female, aged 3-16. • Diagnosis of Tourette Syndrome or another chronic tic disorder according to DSM IV-TR criteria. • Evidence of GAS colonization at any visit of EMTICS Longitudinal Course Study. • Either no current psychotropic medication or on stable anti-tic medication for at least 2 months before the enrolment in the trial. Able (in the Investigators opinion) and willing to comply with all study requirements.
    • Deelnemers en ouders zijn bereid en in staat om geïnformeerde toestemming voor deelname in de studie te geven • Mannelijk of vrouwelijk, leeftijd 3-16 jaar. • Diagnose van Tourette Syndroom of andere chronische ticstoornis overeenkomstig DSM IV-TR criteria. • Bewijs van GAS colonisatie bij elk mogelijk bezoek binnen de EMTICS Course studie. • Of geen momenteel psychotropisch medicatie gebruik of continu gebruik van anti-tic medicatie voor ten minste 2 maanden voor aanvang van deelname aan de studie • In staat (in de ogen van de onderzoeker) en bereid om aan alle studie eisen te voldoen.
    E.4Principal exclusion criteria
    The participant may not enter the study if ANY of the following apply: • Children and/or parents are unable to understand and comply with protocol • Any antibiotic treatment for any reason during the last month before enrolment in the trial. • Clinical manifestations of pharyngitis or other streptococcal infections at moment of enrolment in the trial. • Known or suspected hypersensitivity to penicillin or other β-lactam antibacterials, a history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction. • Known and/or suspected renal or hepatic impairment (due to the potential for drug-related toxicity in patients with such a condition). • Scheduled elective surgery or other procedures requiring general anaesthesia during the study. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. Participants who have participated in another research study involving an investigational product in the past 12 weeks
    De deelnemer mag niet aan de studie deelnemen indien een van de volgende dingen van toepassing is: Kinderen en/of ouders kunnen het studieprotocol niet begrijpen en zich er niet aan houden. • Antibiotica behandeling gedurende de laatste maanden voor deelname aan de studie • Klinische manifestaties van pharyngitis of andere streptokokken infecties op het moment van deelname in de studie • Bekende of verdachte hypergevoeligheid voor penicilline of andere β-lactam antibacterien, een geschiedenis van Amoxicilline-clavulanate- gerelateerde cholestatische gewrichts of hepatische disfunctie
    • Geplande electieve chirurgie of andere procedures die algemene anaesthesie behoeven • Elke andere significante ziekte of stoornis die, in de ogen van de onderzoeker, die voor de deelnemer een risico vormen door deelname in deze studie, of die de resultaten van deze studie beïnvloeden, of de mogelijkheid van deelname in de studie. • Deelnemers die aan ander onderzoek in de afgelopen 12 weken hebben deelgenomen en waarbij een investigational product is gebruikt.
    E.5 End points
    E.5.1Primary end point(s)
    Yale Global Tic Severity Scale (YGTSS) Score
    Yale Global Tic Severity Scale (YGTSS) score
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    1 maand
    E.5.2Secondary end point(s)
    1) Premonitory Urge for Tics Scale (PUTS) 2) Children’s Yale Brown Obsessive-Compulsive Scale (CYBOCS) 3) Symptoms of autism spectrum disorders, ADHD, and internalising and externalising psychopathology a. Social Communication Questionnaire (SCQ). b. Swanson, Nolan, and Pelham, version IV (SNAP-IV) rating scale. c. Strengths and Difficulties Questionnaire (SDQ). 4) Prenatal and perinatal adversities as assessed by parental self-report. 5) Psychosocial stress as measured using the Perceived Stress Scale (PSS), and the PSS-short version. 6) Cortisol levels in hair. 7) Microbiological typing of bacterial GAS population. 8) Anti-Streptococcal Immune Response.
    1) Premonitory Urge for Tics Scale (PUTS) 2) Children’s Yale Brown Obsessive-Compulsive Scale (CYBOCS) 3) Symptomen van autisme spectrum stoornissen, ADHD, en internaliserende en externaliserende psychopathologie. a. Social Communication Questionnaire (SCQ). b. Swanson, Nolan, and Pelham, version IV (SNAP-IV) rating scale. c. Strengths and Difficulties Questionnaire (SDQ). 4) Prenatale en perinatale moeilijkheden zoals gemeted door ouder zelf-rapportage. 5) Psychosociale stress zoals gemeten met de Perceived Stress Scale (PSS), en de PSS-short versie. 6) Cortisol niveau's in haar. 7) Microbiologische typering van bacteriële GAS populatie. 8) Anti-Streptokokken Immuun Respons.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 maanden
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    ''LVLS''
    ''LVLS''
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 72
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    Study medication will not be continued beyond the trial period. Participants will transfer to normal care.
    De studie medicatie zal niet worden voortgezet na het einde van de trial periode. Deelnemers zullen worden overgedragen aan normale behandeling.
    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 Decision2014-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
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