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    Summary
    EudraCT Number:2006-003951-18
    Sponsor's Protocol Code Number:WSA-CS-008
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-003951-18
    A.3Full title of the trial
    A PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BAL8557 VERSUS A CASPOFUNGIN FOLLOWED BY VORICONAZOLE REGIMEN IN THE TREATMENT OF CANDIDEMIA AND OTHER INVASIVE CANDIDA INFECTIONS
    Studio di fase III, in doppio cieco, randomizzato per valutare la sicurezza e l'efficacia di BAL8557 verso un regime di capsofungina seguita da Voriconazolo nel trattamento di candidemia e altre infezioni invasive da candida.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BAL8557 VERSUS A CASPOFUNGIN FOLLOWED BY VORICONAZOLE REGIMEN IN THE TREATMENT OF CANDIDEMIA AND OTHER INVASIVE CANDIDA INFECTIONS
    Studio di fase III, in doppio cieco, randomizzato per valutare la sicurezza e l`efficacia di BAL8557 verso un regime di capsofungina seguita da Voriconazolo nel trattamento di candidemia e altre infezioni invasive da candida.
    A.3.2Name or abbreviated title of the trial where available
    WSA-CS-008
    A.4.1Sponsor's protocol code numberWSA-CS-008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00413218
    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 SponsorASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationND
    B.5.2Functional name of contact pointND
    B.5.3 Address:
    B.5.3.1Street AddressND
    B.5.3.2Town/ cityND
    B.5.3.3Post codeND
    B.5.3.4CountryItaly
    B.5.4Telephone numberND
    B.5.5Fax numberND
    B.5.6E-mailND@ND.ND
    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 No
    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 nameIsavuconazole sulfate
    D.3.2Product code BAL8557
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNANTIMYCOTICS FOR SYSTEMIC USE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number372.6
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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 No
    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 nameIsavuconazole sulfate
    D.3.2Product code BAL8557
    D.3.4Pharmaceutical form Capsule, hard
    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 INNANTIMYCOTICS FOR SYSTEMIC USE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number186.3
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 CANCIDAS
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder for solution for injection
    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 INNCaspofungin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number70
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 VFEND
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule, hard
    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 INNVoriconazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Candidemia and other invasive Candida infections
    Candidemia e altre infezioni invasive da Candida
    E.1.1.1Medical condition in easily understood language
    Candidemia and other invasive Candida infections
    Candidemia e altre infezioni invasive da Candida
    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 10007152
    E.1.2Term Candidiasis
    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 compare the safety and efficacy of treatment with BAL8557 versus a caspofungin (CAS) followed by VRC regimen in patients with candidemia or other invasive Candida infections.
    `Confrontare la sicurezza e l`efficacia del trattamento con BAL8557 verso un regime di caspofungina (CAS) seguita da VRC in pazienti con candidemia o altre infezioni invasive da Candida.
    E.2.2Secondary objectives of the trial
    `To compare the effects of treatment on - Time to first negative blood culture - All-cause 14 and 90-day mortality `To characterize the safety and tolerance of treatment with BAL8557 `To characterize the PK of BAL4815 and cleavage product BAL8278 in the relevant patient population.
    `Paragonare gli effetti di trattamento su- Tempo per la prima coltura di sangue negativa- Mortalita` a 14 e a 90 giorni dovuta a tutte le cause `Caratterizzare la sicurezza e tolleranza del trattamento con BAL8557 `Caratterizzare la PK di BAL4815 e del prodotto di scissione BAL8278 nella popolazione di pazienti di interesse.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:ITA05v01
    Date:2011/02/08
    Title:Optional Pharmacogenomic Sub-study
    Objectives:study genes that may have a correlation with the `fungal infection and response to study drug

    FARMACOGENETICA:
    Vers:ITA05v01
    Data:2011/02/08
    Titolo:sotto studio opzionale di farmacogenetica
    Obiettivi:studio sui geni che potrebbero avere una correlazione con l` infezione micotica e sulla risposta al farmaco in studio

    E.3Principal inclusion criteria
    1. Patients and/or legally authorized representative(s), if applicable, who have been fully informed and have given voluntary written informed consent OR patients unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person. 2. Ability and willingness to comply with the protocol 3. Male and female patients aged `‰¥ 18 years 4. Female patients must be non lactating and at no risk of pregnancy for one of the following reasons - Postmenopausal for at least 1 year - Post hysterectomy and/or post-bilateral ovariectomy - If of childbearing potential, having a negative serum or urine human chorionic gonadotrophin (hCG) pregnancy test at screening and be using a highly effective method of birth control throughout the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study. 5. Patients (neutropenic and non-neutropenic) must have a positive blood or tissue (from at least one otherwise sterile internal organ) culture for candidemia or other invasive Candida infection from a sample obtained within 96 hours prior to randomization, accompanied by related clinical signs and symptoms or histological or cytological changes. Final culture results may still be pending at randomization. 6. Presence of fever (on one occasion > 38°C) or hypotension or appropriate local signs within 96 hours prior to first dose of study medication.
    1. Pazienti e/o rappresentante(i) legalmente autorizzato(i), ove appropriato, i quali sono stati informati in maniera esauriente e che hanno fornito di propria volonta` un consenso informato scritto OPPURE pazienti non in grado di scrivere e/o leggere ma che hanno compreso appieno le informazioni fornite oralmente dallo sperimentatore (o dal rappresentante incaricato), i quali hanno fornito un consenso informato orale attestato per iscritto da una persona indipendente. 2. Capacita` e volonta` di ottemperare al protocollo. 3. Pazienti di sesso maschile o femminile di eta`  18 anni. 4. I pazienti di sesso femminile non devono essere in fase di allattamento o per alcun motivo a rischio di gravidanza per una delle seguenti ragioni: - Postmenopausa da almeno 1 anno - Post isterectomia e/o post ovariectomia bilaterale - Se potenzialmente fertili, allo screening devono presentare un test di gravidanza negativo per le gonadotropine corioniche umane (hCG) sul siero o sulle urine, e fare uso di un metodo altamente efficace di controllo delle nascite per tutta la sperimentazione. Per gli scopi della presente ricerca, come metodo altamente efficace di controllo delle nascite si puo` accettare un`astinenza sessuale attendibile per tutta la durata dello studio. 5. I pazienti (neutropenici e non neutropenici) devono presentare una coltura di sangue o di tessuto (da almeno un organo interno altrimenti sterile) positiva per la candidemia o per un`altra infezione invasiva da Candida derivante da un campione ottenuto entro 96 ore dalla randomizzazione, accompagnata da segni e sintomi clinici correlati oppure da alterazioni a livello istologico o citologico. Alla randomizzazione, i risultati finali della cultura potranno essere ancora in sospeso. 6. Presenza di febbre (nel corso di una volta &gt; 38 °C) o di ipotensione o di opportuni segni locali entro 96 ore dalla prima dose di farmaco in studio.
    E.4Principal exclusion criteria
    1. Women who are pregnant or breastfeeding 2. Known history of allergy, hypersensitivity, or any serious reaction to any of the azole or echinocandin class of antifungals or to any component of the study medication. 3. Patients for whom CAS or VRC is contra-indicated. 4. Patients at high risk for QT/QTc prolongation, such as a family history of long QT syndrome or other known pro-arrhythmic conditions. 5. Evidence of moderate to severe hepatic or renal dysfunction (Child-Pugh score > 6) with any of the following abnormal laboratory parameters at screening: - Total bilirubin `‰¥ 3 x upper limit of normal (ULN) - Alanine transaminase or aspartate transaminase `‰¥ 5 x ULN - Calculated creatinine clearance < 10 mL/minute. 6. Concomitant use of astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine or terfenadine in the 5 days prior to first administration of study medication. 7. Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens. 8. Patients with candidemia who failed a previous antifungal therapy for the same infection. 9. Patients with any invasive fungal infection other than candida spp., e.g., cryptococcosis, mould infection or endemic fungal infection. 10. Microbiological findings (e.g. bacterial infection) or other potential conditions that are temporally related and suggest an alternative etiology of the clinical features. 11. Patients who have received systemic antifungal therapy (i.e. a cumulative dose greater than any of the following: 1 mg/kg amphotericin B; 3 mg/kg liposomal AMB; 800 mg fluconazole; 12 mg/kg VRC; 400 mg itraconazole, 70 mg CAS, 150 mg micafungin, 200 mg anidulafungin), within 96 hours prior to the first administration of study medication. 12. Severe prolonged immunosuppression (e.g. chronic granulomatous disease, severe combined immunodeficiency, advanced human immunodeficiency virus infection with CD4 count < 200 or acquired immunodeficiency syndrome defining condition, severe graft versus host disease [grade III IV associated with e.g., failure of initial treatment, increased liver enzymes or hypoalbuminaemia]), or any other concomitant medical condition that may impede the accurate assessment of efficacy of study drug treatment. 13. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements such as neutropenia not expected to resolve, patients with endocarditis, osteomyelitis, meningitis, uncontrolled malignancy with life expectancy of < 30 days. 14. Patients with a concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she participate in the study. 15. Patients previously enrolled in this study. 16. Treatment with any investigational drug in blinded phase III trials or any phase I and phase II trials within 30 days prior to the first administration of study medication.
    1. Donne in stato di gravidanza o in fase di allattamento. 2. Storia nota di allergia, ipersensibilita`, o una qualunque reazione seria a una classe qualsiasi di antifungini azolici o echinocandinici, oppure a uno qualunque dei componenti del farmaco in studio. 3. Pazienti per i quali il la CAS o il VRC e` controindicato. 4. Pazienti ad alto rischio di prolungamento del QT/QTc, come ad esempio una storia familiare di sindrome del QT lungo, oppure altre condizioni pro-aritmiche note. 5. Evidenze di disfunzione epatica o renale da moderata a severa (punteggio di Child-Pugh &gt; 6), con anomalie a carico di uno qualunque dei seguenti parametri di laboratorio allo screening: - Bilirubina totale  3 x il limite superiore della norma (ULN) - Alanina transaminasi o aspartato transaminasi  5 x l`ULN - Clearance della creatinina calcolata &lt; 10 ml/minuti. 6. Impiego concomitante di astemizolo, cisapride, rifampicina, rifabutina, alcaloidi dell`ergot, barbiturati ad azione prolungata, carbamazepina, pimozide, chinidina, neostigmina o terfenadina, nei 5 giorni precedenti la prima somministrazione del medicinale in studio. 7. Pazienti con solo una diagnosi di candidosi mucocutanea, vale a dire candidosi orofaringea, esofagea o genitale; oppure infezioni delle basse vie urinarie da candida o Candida isolata esclusivamente da campioni del tratto respiratorio. 8. Pazienti con candidemia per i quali una precedente terapia antifungina rivolta alla medesima infezione non ha sortito successo. 9. Pazienti con un`infezione fungina invasiva qualunque diversa da candida spp., per es., una criptococcosi, un`infezione dovuta a muffe oppure un`infezione fungina endemica. 10. Riscontri microbiologici (per es., un`infezione batterica) oppure altre potenziali condizioni che sono temporaneamente correlati e indicativi di un`eziologia alternativa delle caratteristiche cliniche. 11. Pazienti che hanno ricevuto una terapia antifungina sistemica (ossia una dose cumulativa superiore a una qualsiasi delle seguenti: 1 mg/kg di anfotericina B; 3 mg/kg di AMB liposomiale; 800 mg di fluconazolo; 12 mg/kg di VRC; 400 mg di itraconazolo, 70 mg di CAS, 150 mg di micafungina, 200 mg di anidulafungina), entro le 96 ore antecedenti la prima somministrazione del medicinale in studio. 12. Immunosuppressione severa prolungata (per es., malattia granulomatosa cronica, immunodeficienza combinata grave, infezione avanzata da virus dell`immunodeficienza umana con conte CD4 &lt; 200 oppure una condizione che definisce una sindrome da immunodeficienza acquisita, grave malattia da trapianto contro l`ospite [di grado III IV, associata, per es., a insuccesso del trattamento iniziale, enzimi epatici innalzati oppure ipoalbuminemia]), o qualsiasi altra condizione medica concomitante che possa impedire una precisa valutazione dell`efficacia della terapia farmacologica in studio. 13. Qualunque condizione nota o sospetta del paziente che puo` mettere a rischio l`aderenza ai requisiti del protocollo, come ad esempio una neutropenia che non ci si aspetta si possa risolvere, pazienti con endocardite, osteomielite, meningite, neoplasia incontrollata con un`aspettativa di vita &lt; 30 giorni. 14. Pazienti con una condizione medica concomitante che, a giudizio dello sperimentatore, puo` rappresentare un rischio aggiuntivo inaccettabile per il paziente, qualora egli/ella dovesse prendere parte allo studio. 15. Pazienti precedentemente reclutati in questa sperimentazione. 16. Trattamento con un farmaco sperimentale qualsiasi in sperimentazioni di fase III in cieco oppure nel corso di una qualsiasi sperimentazione di fase I e di fase II entro i 30 precedenti la prima somministrazione del farmaco in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response at follow-up 1 visit
    risposta globale alla visita di follow up n.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks after EOT
    2 settimane dopo la visita di fine trattamento
    E.5.2Secondary end point(s)
    Overall response at Day 7, EOT and FU2
    risposta globale al giorno 7 alla visita di fine studio e alla visita di follow up n.2
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks after EOT
    6 settimane dopo la visita di fine studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    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) 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 concerned10
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months26
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months26
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    critically ill, protocol allows for authorized representative to give consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 526
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-03
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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