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    Summary
    EudraCT Number:2015-001752-30
    Sponsor's Protocol Code Number:FoHM/Tonsillit2015
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-21
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-001752-30
    A.3Full title of the trial
    A randomised study of 5 and 10 days treatment with phenoxymethyl penicillin against streptococcal pharyngotonsillitis.
    En randomiserad studie av 5 och 10 dygns behandling med fenoximetylpenicillin vid streptokockorsakad faryngotonsillit. Kan behandlingstid och total antibiotikaexponering reduceras? En prospektiv, randomiserad, öppen multicenterstudie med två parallella grupper och non-inferiority design.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of 5 and 10 days treatment with penicillin against sore throat caused by streptococci.
    Studie av 5 och 10 dygns behandling med penicillin av streptokockorsakad halsfluss. Kan behandlingstiden och totala mängden antibiotika minskas?
    A.4.1Sponsor's protocol code numberFoHM/Tonsillit2015
    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 SponsorPublic Health Agency of Sweden
    B.1.3.4CountrySweden
    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 supportPublic Health Agency of Sweden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPublic Health Agency of Sweden
    B.5.2Functional name of contact pointAntibiotics and Infection Control
    B.5.3 Address:
    B.5.3.1Street AddressNobels väg 18
    B.5.3.2Town/ citySolna
    B.5.3.3Post code17182
    B.5.3.4CountrySweden
    B.5.4Telephone number46102052000
    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 Kåvepenin/Fenoximetylpenicillin
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 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 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
    J03.0 Streptococcal pharyngotonsillitis
    J03.0 Streptokockorsakad faryngotonsillit
    E.1.1.1Medical condition in easily understood language
    Sore throat caused by streptococci
    Halsfluss orsakad av streptokocker
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin in adults, adolecsents and children with streoptococcal tonsillitis.
    Att jämföra klinisk effekt av 5 dygns (800 mg x 4) respektive 10 dygns (1000 mg x 3) behandling med PcV vid faryngotonsillit orsakad av Grupp A streptokocker.
    E.2.2Secondary objectives of the trial
    Bacteriological cure.
    Frequency of relapse.
    Time to relief of symptoms.
    Frequency of purulent and non-purulent complications.
    Ecological impact on feacal microbiota.
    Bakteriologisk utläkning.
    Frekvens recidivinfektioner.
    Tid till symtomfrihet.
    Frekvens purulenta och icke purulenta komplikationer efter avslutad behandling.
    Ekologisk påverkan på tarmfloran.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Ecological impact of 5 and 10 days treatment with phenoxymethylpenicillin on the intestinal microbiota.

    Date and version: Same date and version as the main protocol.

    Objective: To study emergence of resistance against betalactams, colonisation with Clostridium difficile and overgrowth with Candida spp. during and after treatment with phenoxymethylpenicillin. Comparision between treatment arms.
    Titel: Ekologisk påverkan av 5 och 10 dagars behandling med fenoximetylpenicillin på tarmens mikrobiota.

    Datum och version: Samma datum och version som huvudprotokollet.

    Syfte: Att studera resistensutveckling mot betalaktamantibiotika, kolonisering med Clostridium difficile samt överväxt med Candida spp. under och efter behandling med fenoximetylpenicillin. Jämförelse mellan behandlingsarmar.
    E.3Principal inclusion criteria
    Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.
    Vuxna, ungdomar och barn ≥ 6 års ålder med verifierad streptokockorsakad faryngotonsillit.
    E.4Principal exclusion criteria
    Signs of serious infection.
    Known hypersensitivity against penicillin.
    Chronic disease with effect on the immune response.
    Immunosuppressive treatment.
    Streptococcal tonsillitis within one month (relapse).
    Tecken på allvarlig sjukdom.
    Känd överkänslighet mot penicillin.
    Kronisk sjukdom som bedöms påverka immunförsvaret.
    Immunomodulerande medicinering.
    Antibiotikabehandlad GAS tonsillit den senaste månaden (recidiv).
    E.5 End points
    E.5.1Primary end point(s)
    Clinical cure.
    Klinisk utläkning.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5-7 days after discontinuation of treatment.
    5-7 dygn efter avslutad behandling.
    E.5.2Secondary end point(s)
    1. Bacteriological cure.
    2. Frequency of relapses.
    3. Frequency of complications.
    1. Bakteriologisk utläkning.
    2. Frekvens recidiv.
    3. Frekvens komplikationer.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 5-7 Days after discontinuation of treatment.
    2. One month after discontinuation of treatment.
    3. Within 3 months after discontinuation of treatment.
    1. 5-7 dygn efter avslutad behandling.
    2. En månad efter avslutad behandling
    3. Inom 3 månader efter avslutad behandling
    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 Yes
    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
    Samma produkt, fenoximetylpenicillin, men annan doseringsregim.
    Same product, phenpxymethylpenicillin, but other dosage regimen.
    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 concerned16
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    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 Yes
    F.1.1Number of subjects for this age range: 250
    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: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    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
    For children, informed consent will be signed by parents.
    För barn kommer informerat samtycke att signeras av vårdnadshavare.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state432
    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.
    Inga.
    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 Decision2015-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-15
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