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    Summary
    EudraCT Number:2013-002379-17
    Sponsor's Protocol Code Number:2013-CT-ME
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-03
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-002379-17
    A.3Full title of the trial
    MECILLINAM FOR TREATMENT OF GENITAL CHLAMYDIA INFECTION IN ASYMPTOMATIC MEN.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    New treatment for Klamydia infection.
    Ny behandling for Klamydiainfeksjon.
    A.3.2Name or abbreviated title of the trial where available
    Chlamydia - mecillinam
    Klamydia - mecillinam
    A.4.1Sponsor's protocol code number2013-CT-ME
    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 SponsorOslo University Hospital healt Trust
    B.1.3.4CountryNorway
    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 supportMøre and Romsdal Health trust
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOlafiaklinikken, Oslo universitetssykehus
    B.5.2Functional name of contact pointStudiesykepleier, mecillinamstudien
    B.5.3 Address:
    B.5.3.1Street AddressTrondheimsveien 2, Bygg N.
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeN0506
    B.5.3.4CountryNorway
    B.5.4Telephone number004723075840
    B.5.6E-mailUXAAMD@ous-hf.no
    B.Sponsor: 2
    B.1.1Name of SponsorOslo universitetssykehus health trust
    B.1.3.4CountryNorway
    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 supportMøre and Romsdal health trust
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOlafiaklinikken, Oslo University Hospital
    B.5.2Functional name of contact pointStudiesykepleier, mecillinamstudien
    B.5.3 Address:
    B.5.3.1Street AddressTrondheimsveien 2, Bygg N
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeN-0506
    B.5.3.4CountryNorway
    B.5.4Telephone number004723075840
    B.5.6E-mailUXAAMD@ous-hf.no
    B.Sponsor: 3
    B.1.1Name of SponsorOslo University Hospital Health Trust
    B.1.3.4CountryNorway
    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 supportMøre and Romsdal Health Trust
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointOlafiaklinikken
    B.5.3 Address:
    B.5.3.1Street AddressTrondheimsveien 2, bygg N
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeN-0506
    B.5.3.4CountryNorway
    B.5.4Telephone number004723075840
    D. IMP Identification
    D.IMP: 1
    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 No
    D.2.1.1.1Trade name Selexid
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameSELEXID
    D.3.2Product code SUB03884MIG
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePIVMECILLINAM HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03884MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Asymptomatic genital Chlamydia Trachomatis infection
    E.1.1.1Medical condition in easily understood language
    Genital Chlamydia infection without sypmtoms.
    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 LLT
    E.1.2Classification code 10070169
    E.1.2Term Chlamydia trachomatis test positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10063313
    E.1.2Term Chlamydial DNA test positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10067198
    E.1.2Term Chlamydia trachomatis infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008540
    E.1.2Term Chlamydia trachomatis infection of lower genitourinary sites
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to prove the concept of treating genital Chlamydia trachomatis infection with mecillinam po..
    E.2.2Secondary objectives of the trial
    Form the basis for a larger randomised trials with the goal of documenting a new treatment for genital Chlamydia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Proficient in oral and written Norwegian.
    • Positive NAAT in first void urine for Chlamydia trachomatis.
    • Negative NAAT in first void urine for Mycoplasma genitalium.
    • Male gender.
    • 18 years old or older.
    • Hetero sexual.
    • Asymptomatic.
    • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    • Known allergies for mecillinam, penicillin or cephalosporines.
    • Metabolic anomalies of aciduretic type.
    • Apparent underweight.
    • Use of valporate.
    • Use of mecillinam within the last two months.
    • Under treatment with other anti-infective drugs.
    • Use of immuno-modulative medication i.e. metotrexate, Interferone gamma, tumor necrosis factor inhibitors or monoclonal antibodies.
    • If there are, in the opinion of the investigator, obvious reasons why the patient will fail to adhere to the treatment and follow-up protocol. I.e. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
    E.5 End points
    E.5.1Primary end point(s)
    Negative test of cure. (Nucleic Acid Amplification Test)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three to six weeks after end of treatment
    E.5.2Secondary end point(s)
    Tolerability of the treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continous during treatment up to the timepoit of delivering test of cure sample.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 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
    When the last included participant has delivered test of cure sample and follow-up questionnaire, or when the last participant is deemed "lost from follow-up".(Not returned follow-up questionnaire within 6 weeks after treatment.)
    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 months5
    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: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state50
    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)
    Patients who withdraw or are withdrawn from the study, will stop further treatment with the investigated drug. The reason for discontinuation shall be recorded. The investigator is obliged to follow up any significant adverse events until the outcome is defined.
    The participant may choose to complete study treatment or receive rescue treatment immediately. A follow-up sample will be encouraged and the result will be given to the participant by phone as soon as possible.
    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 Decision2013-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-28
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