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    Summary
    EudraCT Number:2014-003024-46
    Sponsor's Protocol Code Number:Repha_1412
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003024-46
    A.3Full title of the trial
    Efficacy, safety and tolerability of Angocin Anti-Infekt N versus Placebo for MRSA eradication
    Klinische Prüfung zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit der Anwendung von Angocin Anti-Infekt N versus Placebo zur MRSA-Eradikation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety and tolerability of Angocin Anti-Infekt N versus Placebo for MRSA eradication
    Klinische Prüfung zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit der Anwendung von Angocin Anti-Infekt N versus Placebo zur MRSA-Eradikation
    A.3.2Name or abbreviated title of the trial where available
    AMErS
    AMErS
    A.4.1Sponsor's protocol code numberRepha_1412
    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 SponsorRepha GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRepha GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMediconomics GmbH
    B.5.2Functional name of contact pointClinical Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressMisburger Str. 81B
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number00495115609980
    B.5.5Fax number004951156099820
    B.5.6E-mailinfo@mediconomics.com
    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 Angocin Anti-Infekt N
    D.2.1.1.2Name of the Marketing Authorisation holderRepha GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Film-coated 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.3.8INN - Proposed INNHorseradish root powder
    D.3.9.3Other descriptive nameMeerrettichwurzelpulver
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 INNNasturtium herb powder
    D.3.9.3Other descriptive nameKapuzinerkressenkrautpulver
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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 placeboFilm-coated tablet
    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
    MRSA colonisation
    MRSA Kolonisation
    E.1.1.1Medical condition in easily understood language
    MRSA colonisation
    MRSA Kolonisation
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10004017
    E.1.2Term Bacterial disease carrier
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068296
    E.1.2Term MRSA colonisation
    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
    Evaluation of efficacy, safety and tolerability of Angocin Anti-Infekt N administered for MRSA eradication
    Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit von Angocin Anti-Infekt N bei der Anwendung zur MRSA-Eradikation
    E.2.2Secondary objectives of the trial
    Not applicable
    Nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with MRSA colonisation of the nasal vestibule or concurrent MRSA-colonisation of nasal vestibule and throat
    - Male and female patients aged ≥ 18 years
    - Signed written informed consent
    - .....
    - Ambulante Patienten mit einer MRSA-Kolonisation des Nasenvorhofs oder gleichzeitige Kolonisation des Nasenvorhofs und des Rachenraums
    - Patienten beiderlei Geschlechts im Alter ≥ 18 Jahren
    - Schriftliche Einverständniserklärung liegt vor
    - .....
    E.4Principal exclusion criteria
    - Patients with additional MRSA-positive localizations except nasal vestibule and throat (armpits, groin or perineum)
    - Current MRSA-infection
    - signs or symptoms of a beginning bacterial or viral infection in combination with fever (> 38.5°C)
    - Patient with urgent incation for sanitation (e.g. planned surgery, immunsuppressiv status, persons at risk in home Environment, caMRSA-colonisation/infection)
    - Patients with penetrating foreign objects (e.g. tracheostoma, catheter, PEG tube, shunts, etc.)
    - Pateints with sanitation-inhibiting factors
    - Treatment with antibiotics 7 days prior and during study participation
    - Intensive care during study participation
    - Chronic need for care (level 1 at least)
    - Patients with impaired phagocyte function like diabetic persons or patients requiring dialysis
    - Acute nephritis
    - Patients with acute gastric and/or intestinal ulcers
    - Immuno-compromised patients
    - Persons dependent from the sponsor or from a contract organization participating in the conduct of the clinical trial
    - Patients with confirmed active COVID-19 disease or SARS-CoV-2 infection
    - Signs or symptoms of COVID-19 disease or SARS-CoV-2 infection at the discretion of the investigator
    - Patienten mit zusätzlichen MRSA-positiven Lokalisationen außer Nasenvorhof und Rachenraum (Achseln, Leiste oder Perineum)
    - bestehende MRSA-Infektion
    - Anzeichen oder Symptome einer beginnenden bakteriellen oder viralen Infektion einhergehend mit Fieber (> 38,5 °C)
    - Patienten mit dringender medizinischer Indikation für eine Sanierungsbehandlung (z.B. anstehende OP, immunsuppressiver Status, gefährdete Person im häuslichen Umfeld, caMRSA Besiedlung/Infektion)
    - Patienten mit liegenden penetrierenden Fremdkörpern (z.B. Tracheostoma, Katheter, PEG Sonde, Shunts, etc.)
    - Patienten mit sonstigen sanierungshemmenden Faktoren
    - Antibiotikaeinnahme innerhalb der letzten 7 Tage oder während der Prüfungsteilnahme
    - Aufenthalt auf einer Intensivstation bzw. Notwendigkeit einer intensivmedizinischen Behandlung während der Prüfungsteilnahme
    - Chronische Pflegebedürftigkeit (mindestens Stufe 1)
    - Patienten mit verminderter Phagozytenfunktion wie Diabetiker und dialysepflichtige Patienten
    - Akute Nierenentzündungen
    - Patienten mit akuten Magen- und/oder Darmgeschwüren
    - Immungeschwächte Patienten
    - Personen, die vom Sponsor oder von einer vom Sponsor beauftragten, an der Durchführung der Studie beteiligten Stelle abhängig sind
    - Patienten mit bestätigter aktiver COVID-19-Erkrankung bzw. SARS-CoV-2-Infektion
    - Anzeichen oder Symptome einer COVID-19-Erkrankung bzw. SARS-CoV-2-Infektion nach Ermessen des Prüfarztes
    E.5 End points
    E.5.1Primary end point(s)
    Ratio of successfully sanitised patients within the test group and the placebo group
    Rate erfolgreich sanierter Patienten in Prüf- und Vergleichsgruppe
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of sanitation (i.e. after 8-week medication intake at maximum and control of sanitation)
    Nach Abschluss der Sanierung (d.h. nach maximal 8-wöchiger Medikationseinnahme und Kontrolle der Sanierung)
    E.5.2Secondary end point(s)
    Efficacy
    - Duration of sanitation
    - Investigator's assessment of efficacy
    Safety and tolerability
    - Type, frequency and severity of reported adverse Events
    - Laboratory findings of blood samples: Haematology and clinical chemistry
    - Vital signs: Heart rate, blood pressure, body temperature
    - Investigator's and patient's assessment of tolerability
    Wirksamkeit
    - Dauer der Sanierung
    - Beurteilung der Wirksamkeit durch den Prüfarzt
    Sicherheit und Verträglichkeit
    - Art, Häufigkeit und Schweregrad der unerwünschten Ereignisse
    - Laborparameter der Blutproben: Hämatologie und Klinische Chemie
    - Vitalparameter: Puls, Blutdruck, Körpertemperatur
    - Bewertung der Verträglichkeit durch den Prüfarzt und den Patienten
    E.5.2.1Timepoint(s) of evaluation of this end point
    After completion of sanitation (i.e. after 8-week medication intake at maximum and control of sanitation)
    Nach Abschluss der Sanierung (d.h. nach maximal 8-wöchiger Medikationseinnahme und Kontrolle der Sanierung)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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
    End of trial is defined as last visit of last patient
    Ende der klinischen Prüfung ist definiert als der letzte Besuch des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state92
    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)
    Not applicable
    Nicht zutreffend
    (Sofern erforderlich, besteht für alle Patienten die Möglichkeit, nach Beendigung der Teilnahme an der klinischen Prüfung nach Maßgabe des Arztes weiter behandelt zu werden.)
    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 Decision2014-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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