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    Summary
    EudraCT Number:2012-005101-51
    Sponsor's Protocol Code Number:RIVM-V/330564/01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005101-51
    A.3Full title of the trial
    Tick Test & Prophylaxis Proof
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tick Test & Prophylaxis Proof
    A.3.2Name or abbreviated title of the trial where available
    TT&PP
    A.4.1Sponsor's protocol code numberRIVM-V/330564/01
    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 SponsorNational Institute of Health and the Environment (Dutch acronym: RIVM)
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute of Health and the Environment (Dutch acronym: RIVM)
    B.5.2Functional name of contact pointSecretariat Epid. and Surveillance
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 1
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720 BA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31302743159
    B.5.5Fax number+31302744409
    B.5.6E-mailsecretariaat.epi@rivm.nl
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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.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
    Lyme disease
    E.1.1.1Medical condition in easily understood language
    Lyme disease
    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 10025169
    E.1.2Term Lyme disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of antibiotic prophylaxis after a tick bite in the Dutch setting in relation to Borrelia infection of the tick, tick engorgement and attachment time.
    E.2.2Secondary objectives of the trial
    (1) to assess the reduction in NNT when only prescribing prophylaxis if the tick is infected and the engorgement or attachment time is above a certain threshold.
    (2) to assess whether the efficacy of antibiotic prophylaxis after a tick bite is different for children than for adults (8-17 yrs of age vs 18 yrs and older).
    (3) to distinguish between prophylaxis efficacy for preventing early Lyme disease and more severe and/or chronic manifestations
    (4) to determine the risk of adverse events (AEs) due to taking prophylaxis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Persons who:
    - are 8 yrs and older
    - are not pregnant
    - report a recent tick bite on the webportal Tekenradar.nl – i.e. at the moment of inclusion they are able to take prophylaxis within 72 hrs after removal of the tick.
    - are willing to send the tick to the RIVM.
    E.4Principal exclusion criteria
    - are unable to give informed consent or do not have a thorough command of the Dutch language.
    Persons who:
    - report other tick bites in the three months before inclusion.
    - have a contra indication for treatment with doxycycline (including pregnancy).
    - are – at the moment inclusion – not able to take prophylaxis within 72 hours after removal of the tick
    E.5 End points
    E.5.1Primary end point(s)
    Erythema migrans and other diagnosed manifestations of Lyme disease (i.e. other skin manifestations, ocular manifestations, neuroborreliosis, Lyme arthritis, Lyme carditis and chronic complaints), in relation to receiving prophylaxis and the tick screening results (i.e. tick infection with Borrelia, engorgement and attachment time).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During any point of the follow-up period of 18 months.
    E.5.2Secondary end point(s)
    The number of participants that develop AEs in the month after taking the prophylaxis. Scores for other epidemiological risk factors for acquiring tick bites and developing Lyme disease such as exposure to ticks in daily life, participants’ activities when acquiring the tick bite, area of acquiring the tick bite, prevention of tick bites. Differences in NNT for children and adults. Treatment of reported erythema migrans and other Lyme manifestations. Development of chronic complaints such as fatigue, headache, arthalgia, cognitive disturbances.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During any point of the follow-up period of 18 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 No
    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 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 treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    The last questionnaire being completed by the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 350
    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: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 250
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 2012-12-13. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children age 8-18 years are included. In this age group doxycycline treatment of a diagnosed Borrelia-infection is indicated. The efficacy of prophylaxis is investigated in all age groups that would receive treatment in case of a diagnosed infection.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2500
    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)
    None
    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 Decision2012-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-09
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