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    Summary
    EudraCT Number:2012-003172-39
    Sponsor's Protocol Code Number:Mica1/2012
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-003172-39
    A.3Full title of the trial
    Micafungin-Deescaltion study: Evalutating the rate of breakthrough infections of micafungin followed by fluconazole versus fluconazole (or other azoles) in febrile patients
    Micafungin-Deeskalationsstudie: Evaluierung der Rate an Durchbruchsinfektionen unter Micafungin gefolgt von Fluconazol versus Fluconazol (oder andere Azole) bei febrilen Patienten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Micafungin-Step therapy: Evaluating the rate of fungal infection diseases arising during antifungal therapy with micafungin followed by fluconazole versus fluconazole-monotherapy (or other azoles) in febrile patients
    Micafungin-Stufentherapie: Evaluierung der Rate an Pilzinfektionserkrankungen unter antifungaler Therapie mit Micafungin gefolgt von Fluconazol versus Fluconazol-Monotherapie (oder andere Azole) bei febrilen Patienten
    A.3.2Name or abbreviated title of the trial where available
    Micafungin-Deescalation study
    A.4.1Sponsor's protocol code numberMica1/2012
    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 SponsorMedizinische Universität Innsbruck, Abteilung für Hygiene und Medizinische Mikrobiologie
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Innsbruck, Abteilung für Hygiene und Medizinische Mikrobiologie
    B.5.2Functional name of contact pointCornelia Lass-Flörl
    B.5.3 Address:
    B.5.3.1Street AddressFritz-Pregl-Strasse 3
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number0043512900370703
    B.5.5Fax number0043512900373700
    B.5.6E-mailcornelia.lass-floerl@i-med.ac.at
    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 Yes
    D.2.1.1.1Trade name Mycamine
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMicafungin/Mycamine
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 208538-73-2
    D.3.9.3Other descriptive nameMICAFUNGIN SODIUM
    D.3.9.4EV Substance CodeSUB20666
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 mg
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Diflucan
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Corporation Austria Ges.m.b.H., Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameFluconazole/Diflucan
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameFLUCONAZOLE
    D.3.9.4EV Substance CodeSUB07674MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2 mg/ml
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Vfend
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVoriconazol/Vfend
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVORICONAZOLE
    D.3.9.1CAS number 137234-62-9
    D.3.9.4EV Substance CodeSUB00087MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 mg
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Sporanox
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN - CILAG Pharma GmbH, 1020 Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameItraconazole/Sporanox
    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.3.8INN - Proposed INNITRACONAZOLE
    D.3.9.1CAS number 84625-61-6
    D.3.9.4EV Substance CodeSUB08353MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 mg
    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
    All patients who are suspicious of suffering from invasive fungal infections are included.
    Es werden all jene Patienten in die Studie eingeschlossen, bei welchen der Verdacht auf das Vorliegen einer invasiven Pilzinfektion besteht.
    E.1.1.1Medical condition in easily understood language
    All patients who are suspicious of suffering from invasive fungal infections are included.
    Es werden all jene Patienten in die Studie eingeschlossen, bei welchen der Verdacht auf das Vorliegen einer invasiven Pilzinfektion besteht.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    The main objective is to determine the rate of breakthrough fungal infections in a step down therapy consisting of micafungin followed by fluconazol comparted to fluconazole (or other azoles) monotherapy.
    Das Hauptziel der Studie ist die Erhebung der Rate an fungalen Durchbruchsinfektions von während einer Stufentherapie bestehend aus Micafungin gefolgt von Flucoanzol verglichen mit der Rate an Durchbruchsinfektionen während einer Flucoanzol (oder andere Azole) Monotherapie.
    E.2.2Secondary objectives of the trial
    not applicable
    nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Suspicious of suffering from invasive fungal infections
    • Female and male patients of > 18 years of age
    • Patient receives appropriate antibiotic therapy
    • Informed consent form signed by the patient or by the legal representative
    • No treatment with antifungal agents 30 days prior to inclusion in the study
    • Verdacht einer bestehenden invasiven Pilzinfektion
    • Weibliche und männliche Patienten >18 Jahre
    • Patienten mit adäquater antibiotischer Behandlung
    • Vorliegende Einwilligungserklärung des Patienten
    • Keine antimykotische Therapie 30 Tagen vor Einschluss in die Studie

    E.4Principal exclusion criteria
    • Known or expected hypersensitivity to active test substances or excipients
    • Chronic liver disease by pathologic confirmation of cirrhosis, or Child-Pugh Stage B or C
    • History or present signs of acute liver injury
    • Previous enrollment to the present study
    • Participation in another clinical trial with an investigational drug or investigational device during the last 30 days
    • Received study drugs in the last 30 days prior to randomization.
    • Positive pregnancy test
    • Detection of Candida krusei or other Candida species resistant to fluconazole or micafungin
    • Expected fatal or most likely unfavorable clinical outcome
    •Bekannte oder erwartete Unverträglichkeit der Testsubstanzen
    • Chronische Lebererkrankung mit histologischem Nachweis einer Leberzirrhose oder Child-Pugh Stage B oder C
    • Anamnese oder Zeichen eines akuten Leberversagens
    • Patienten, welche bereits in diese Studie eingeschlossen wurden
    • Teilnahme an einer anderen Arzneimittelstudie innerhalb der letzten 30 Tage
    • Erhalt einer anderen Testsubstanz innerhalb der letzten 30 Tage
    • Patientinnen mit pos. Schwangerschaftstest
    • Nachweis einer Candida krusei oder einer anderen Candidaspezies, die resistent auf Fluconazol oder Micafungin getestet wird
    • Patienten, bei welchen ein schlechtes klinisches Outcome bzw. tödlicher Ausgang erwartet wird
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the determation of the rate of breakthrough fungal infections in a step down therapy consisting of micafungin followed by fluconazol comparted to fluconazole (or other azoles) monotherapy.
    Der primäre Endpunkt stellt die Erhebung der Rate an fungalen Durchbruchsinfektions von während einer Stufentherapie bestehend aus Micafungin gefolgt von Flucoanzol dar verglichen mit der Rate an Durchbruchsinfektionen während einer Flucoanzol (oder andere Azole) Monotherapie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28 ± 2 after starting of antifungal therapy
    Tag 28 ± 2 nach Beginn der antifungalen Therapie
    E.5.2Secondary end point(s)
    The secondary endpoints will be the length of in hospital stay and the length of Intensive Care Unit stay, total days of antifungal treatment, fungal colonization index, changes from baseline values of the SOFA score (=sequential organ failure assessment), incidence of drug related unexpected serious adverse events and survival rate.
    Der sekundäre Endpunkt gelten die Dauer des Krankenhausaufenthaltes/Aufenthalt an der Intensivstation, Gesamtdauer der antifungalen Therapie, Pilzkolonisationindex, SOFA-Score, unerwünschte Arzneimittelwirkungen und die Überlebensrate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - days 7 ±1, 14±2 and 28±2 after start of antifungal treatment: Fungal Colonisation
    - days -1-0, 1-5, 7 ±1, 14±2, 21±2 and 28±2: changes from baseline values of the sequential organ failure assessment score (determination of laboratory parameters are included)
    - Daily screening for adverse drug effects + Screening 6 month after start of antifungal treatment
    - days 7±1, 14±2, 28±2 and 6 month after start of therapy: Survival Rate
    - Tag 7 ±1, 14±2 und 28±2 nach Beginn der antifungalen Therapie: Pilzkolonisation
    - Tag -1-0, 1-5, 7 ±1, 14±2, 21±2 und 28±2: Veränderungen von Organfunktionen (inklusive Erfassung von laborchemischen Parametern)
    - Tägliches Screening auf unerwartete Nebenwirkungen + Screening 6 Monate nach Beginn der antimykotischen Therapie
    - Tag 7±1, 14±2, 28±2 und 6 Monate nach Beginn der antimykotischen Therapie: Überlebensrate
    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) 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) Yes
    E.8.2.2Placebo No
    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 concerned8
    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 end of the trial will be the follow-up of the last subject included in the study.
    Das Ende der Studie stellt das Follow-up des Patienten, welcher als letzter in die Studie eingeschlossen wurde, dar.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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.1.3Elderly (>=65 years) Yes
    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 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 state190
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 190
    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)
    In order to investigate long-term side effects and survival, a follow-up examination will be conducted 6 months after first study drug administration.
    6 Monate nach Erstgabe der Studienmedikation folgt ein Follow-up, um potentielle Langzeitnebenwirkungen und Überlebensrate zu erfassen.
    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 Decision2013-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-30
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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