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    Summary
    EudraCT Number:2016-003059-31
    Sponsor's Protocol Code Number:CF-301-102
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003059-31
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia) Including Right-Sided Endocarditis
    Studio comparativo, randomizzato, multicentrico e in doppio cieco volto a valutare la sicurezza, la tollerabilità, l'efficacia e il profilo farmacocinetico di CF-301 rispetto al placebo in aggiunta alla terapia antibatterica standard di cura per il trattamento di pazienti adulti affetti da infezioni del torrente circolatorio provocate da Staphylococcus aureus (batteriemia), ivi compresa l'endocardite del cuore destro
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy, Safety and Pharmacokinetics of CF-301 Compared with Placebo in addition to Standard-of-Care antibiotic therapy in Blood Infections caused by S. aureus, including heart valve infections
    Studio volto a valutare la sicurezza, l'efficacia e il profilo farmacocinetico di CF-301 rispetto al placebo in aggiunta alla terapia antibatterica standard di cura per il trattamento degli infezioni del torrente circolatorio provocate da Staphylococcus aureus, ivi comprese le infezioni delle valvole cardiache
    A.3.2Name or abbreviated title of the trial where available
    Study to Assess the Efficacy, Safety and Pharmacokinetics of CF-301 Compared with Placebo in additio
    Studio volto a valutare la sicurezza, l'efficacia e il profilo farmacocinetico di CF-301 rispetto al
    A.4.1Sponsor's protocol code numberCF-301-102
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorCONTRAFECT CORPORATION
    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 supportContraFect Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationContraFect Corporation
    B.5.2Functional name of contact pointClinical Development Corporation
    B.5.3 Address:
    B.5.3.1Street Address28 Wells Ave
    B.5.3.2Town/ cityYonkers, NY
    B.5.3.3Post code10701
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019142072300
    B.5.5Fax number0019142072399
    B.5.6E-mailclinicalstudies@contrafect.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 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 nameNA
    D.3.2Product code [CF-301]
    D.3.4Pharmaceutical form Concentrate 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 INNExebacase
    D.3.9.1CAS number 1404122-92-4
    D.3.9.2Current sponsor codeCF-301
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    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
    S. aureus bloodstream infections
    Infezioni del circolo ematico da S.aureus
    E.1.1.1Medical condition in easily understood language
    Blood infections, including heart valve infections
    Infezioni del sangue, incluse le infezioni della valvola cardiaca
    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 LLT
    E.1.2Classification code 10021839
    E.1.2Term Infection MRSA
    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 10077008
    E.1.2Term Methicillin-sensitive Staphylococcus aureus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10003997
    E.1.2Term Bacteraemia
    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 10054637
    E.1.2Term Staphylococcal bacteremia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10041937
    E.1.2Term Staphylococcus aureus endocarditis
    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 PT
    E.1.2Classification code 10014665
    E.1.2Term Endocarditis
    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 describe the safety and tolerability of CF-301 vs. placebo in addition to SOC antibacterial therapy for the treatment of patients with S. aureus BSIs including right-sided endocarditis.
    • To estimate clinical outcome at Day 14 after CF 301/placebo administration.
    • To describe the PK parameters of CF-301.
    - Descrivere la sicurezza e la tollerabilità di CF-301 rispetto al placebo in aggiunta alla terapia antibatterica standard di cura (Standard of Care, SOC) per il trattamento di pazienti affetti da
    infezioni del torrente circolatorio (Bloodstream Infection, BSI) provocate da Staphylococcus
    aureus, ivi compresa l’endocardite del cuore destro;
    - Valutare l’esito clinico al Giorno 14 dopo la somministrazione di CF-301 o del placebo;
    - Descrivere i parametri di farmacocinetica (Pharmacokinetics, PK) di CF-301.
    E.2.2Secondary objectives of the trial
    • To estimate clinical outcome at Day 7 after CF-301/placebo administration, at the end of SOC antibacterial therapy (EOT), and at test-of-cure (TOC) 28 days after the EOT.
    • To estimate microbiological response at Days 7 and 14 after CF-301/placebo administration.
    • To estimate microbiological outcome at EOT and at TOC
    - Valutare l’esito clinico al Giorno 7 dopo la somministrazione di CF-301 o del placebo, al termine della terapia (End of Therapy, EOT) antibatterica SOC e al test di cura (Test of Cure, TOC)
    previsto 28 giorni dopo l’EOT;
    - Valutare la risposta microbiologica ai Giorni 7 e 14 dopo la somministrazione di CF-301 o del
    placebo;
    - Valutare l’esito microbiologico all’EOT e al TOC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • male or female, 18 years or older.
    • blood culture positive for S. aureus.
    • at least one sign or symptom attributable to S. aureus bacteremia.
    • known or suspected right-sided endocarditis by Modified Duke Criteria and/or known or suspected complicated S. aureus BSI.
    • patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential.
    - pazienti di sesso maschile o femminile e di età pari o superiore a 18 anni.
    - coltura ematica positiva a S. aureus.
    - almeno un segno o sintomo attribuibile alla batteriemia da Staphylococcus aureus.
    - Endocardite del cuore destro nota o sospetta secondo i criteri di Duke modificati e/o BSI da S. aureus complicata nota o sospetta.
    - Pazienti non sono in stato di gravidanza né in fase di allattamento, in età fertile e, se in età fertile, acconsentono ad usare metodi anticoncezionali.
    E.4Principal exclusion criteria
    • patient previously received CF-301.
    • treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 72 hours within 7 days before randomization.
    • presence of any removable infection source that will not be removed or debrided within 72 hours after randomization.
    • presence of infected prosthetic joint or presence of cardiac device.
    • known or suspected left-sided endocarditis, brain abscess, osteomyelitis or meningitis.
    • pneumonia or known polymicrobial bacteremia.
    • patient is employed by the sponsor or investigational site or is a first degree relative of a person employed by the sponsor or investigational site. Patient is institutionalized by administrative or court order.
    - Pazienti precedentemente trattati con CF-301
    - Trattamento con qualsiasi antibiotico sistemico (anti-stafilococcico) potenzialmente efficace per
    oltre 72 ore entro 7 giorni prima della randomizzazione.
    - Presenza di qualsiasi fonte di infezione asportabile che non verrà asportata o sbrigliata entro 72 ore dopo la randomizzazione.
    - Presenza di articolazione protesica infetta o presenza di dispositivo cardiaco.
    - Endocardite del cuore sinistro nota o sospetta, ascesso cerebrale noto o sospetto, osteomielite o meningite nota o sospetta.
    - Polmonite o batteriemia polimicrobica.
    - Pazienti assunto dallo sponsor o presso il centro sperimentale oppure parente di primo grado di
    un individuo assunto dallo sponsor o presso il centro sperimentale. Il paziente è istituzionalizzato per ordine amministrativo o giudiziario.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety and tolerability of CF-301 vs placebo in addition to standard-ofcare
    antibacterial therapy
    • Clinical outcome at Day 14 after CF-301/placebo administration
    • pharmacokinetic parameters of CF-301
    • Sicurezza e tollerabilità di CF-301 rispetto al placebo in aggiunta alla terapia antibatterica standard di cura
    • Valutare l’esito clinico al Giorno 14 dopo la somministrazione di CF-301 o del placebo
    • Parametri farmacocinetici di CF-301
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Clinical outcome at Day 14 after CF-301/placebo administration
    • PK parameters of CF-301: subsets of patients will give serial PK samples from either pre-dose through 48 hours, between 2.25 hours and 24 hours or 2.25 hours and 48 hours after the start of the study drug infusion
    • Sicurezza e tollerabilità di CF-301: Tempo di consenso attraverso test di cura
    • Valutare l’esito clinico al giorno 14 dopo somministrazione di CF-301/placebo
    • Parametri farmacocinetici di CF-301: sottogruppi di pazienti forniranno campioni seriali di PK dalla pre-dose fino a 48 ore, tra 2.25 e 24 ore o 2,25 ore e 48 ore dopo l'inizio dell’infusione del farmaco in studio
    E.5.2Secondary end point(s)
    • Clinical outcome at Day 7 after CF301/placebo administration
    • Clinical outcome at the end of SOC antibacterial therapy (EOT), and at
    test of cure (TOC), and 28 days after EOT
    • Microbiological response
    • Microbiological outcome
    • Valutazione clinica al giorno 7 dopo somministrazione di CF-301/placebo
    • Valutazione clinica al termine della terapia antibatterica SOC (EOT), al test di cura (TOC), e 28 giorni dopo l’EOT
    • Valutare la risposta microbiologica
    • Valutare l’esito microbiologico
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Clinical outcome: at Day 7 after CF-301/placebo administration, end of
    standard of care antibacterial therapy (EOT), at test of cure, 28 days
    after end of standard of care therapy
    • Microbiological response: at Days 7 and 14 after CF-301/placebo
    administration
    • Microbiological outcome at End of therapy and Test of cure (28 days
    after end of therapy)
    • Valutare l’esito clinico al Giorno 7 dopo la somministrazione di CF-301 o del placebo, al termine della terapia (End of Therapy, EOT) antibatterica SOC e al test di cura (Test of Cure, TOC) previsto 28 giorni dopo l’EOT
    • Valutare la risposta microbiologica ai Giorni 7 e 14 dopo la somministrazione di CF-301 o del placebo
    • Valutare l’esito microbiologico all’EOT e al TOC (28 giorni dopo la fine della terapia)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Chile
    Guatemala
    Israel
    Russian Federation
    United States
    Belgium
    Bulgaria
    France
    Germany
    Italy
    Spain
    United Kingdom
    Czechia
    Argentina
    Greece
    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
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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.1.1.1In 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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 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
    Some patients eligible for this protocol will not be able to give fully informed consent due to sedation, unconscious state, etc. If a patient is not able to provide informed consent, he/she can be enrolled according to local regulatory requirements.
    Alcuni pazienti che beneficiano di questo protocollo non saranno in grado di fornire il loro consenso informato a causa della sedazione, dello stato di incoscienza ecc. Se un paziente non è in grado di fornire il suo consenso informato, lui può esser
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 115
    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)
    As per standard of care.
    Secondo lo standard di cura.
    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 Decision2017-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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