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    Summary
    EudraCT Number:2015-004703-23
    Sponsor's Protocol Code Number:1424R2131
    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:2018-02-05
    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 number2015-004703-23
    A.3Full title of the trial
    A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
    Studio clinico in aperto, randomizzato, multicentrico, di S-649266 o della migliore terapia disponibile per il trattamento di infezioni gravi causate da patogeni Gram-negativi carbapenemi-resistenti
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
    Studio di S-649.266 o della migliore terapia disponibile per il trattamento di infezioni gravi causate da patogeni Gram-negativi carbapenemi-resistenti
    A.3.2Name or abbreviated title of the trial where available
    CREDIBLE-CR
    CREDIBLE-CR
    A.4.1Sponsor's protocol code number1424R2131
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02714595
    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 SponsorSHIONOGI LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportShionogi & Co., Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi & Co., Ltd
    B.5.2Functional name of contact pointCorporate Communications Department
    B.5.3 Address:
    B.5.3.1Street Address1-8, Doshomachi 3-chome
    B.5.3.2Town/ cityChuo-ku, Osaka
    B.5.3.3Post code541-0045
    B.5.3.4CountryJapan
    B.5.4Telephone number0081662097885
    B.5.5Fax number0000000000
    B.5.6E-mailshionogiclintrials-admin@shionogi.co.jp
    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 name.
    D.3.2Product code [S-649266]
    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 INNCefiderocol
    D.3.9.2Current sponsor codeS-649266
    D.3.9.3Other descriptive nameS-649266
    D.3.9.4EV Substance CodeSUB131099
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 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
    Hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gramnegative pathogens.
    Complicated urinary tract infection (cUTI) caused by carbapenemresistant Gram-negative pathogens.
    Polmonite ospedaliera (HAP, hospital acquired pneumonia)/polmonite associata al ventilatore (VAP, ventilator associated pneumonia)/polmonite associata all'assistenza sanitaria (HCAP, healthcare-associated pneumonia)o con infezioni del torrente circolatorio (BSI, bloodstream infections)/sepsi causate da patogeni Gram-negativi carbapenemi-resistenti.
    Infezione delle vie urinarie complicata (cUTI, urinary tract infection) causata da patogeni Gram-negativi carbapenemi-resistenti.
    E.1.1.1Medical condition in easily understood language
    Severe infections caused by Carbapenem-resistant Gram-negative pathogens.
    Gravi infezioni causate da patogeni Gram-negativi resistenti ai carbapenemi.
    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 10076918
    E.1.2Term Hospital acquired pneumonia
    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 SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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 10065153
    E.1.2Term Ventilator associated pneumonia
    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 HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    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 assess, at test of cure (TOC), the clinical outcome of treatment with S-649266 or best available therapy (BAT) in adult patients with either hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gramnegative pathogens.
    ¿To assess, at TOC, the microbiologic outcome of treatment with S-649266 or BAT in adult patients with complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens.
    • Valutare, al test di cura (TOC, test of cure)1, l'esito clinico del trattamento con S-649266 o con la migliore terapia disponibile (BAT, best available therapy) nei pazienti adulti con polmonite ospedaliera (HAP, hospital acquired pneumonia)/polmonite associata al ventilatore (VAP, ventilator associated pneumonia)/polmonite associata all'assistenza sanitaria (HCAP, healthcare-associated pneumonia) o con infezioni del torrente circolatorio (BSI, bloodstream infections)/sepsi2 causate da patogeni Gram-negativi carbapenemi-resistenti.
    • Valutare, al TOC, l'esito microbiologico del trattamento con S-649266 o BAT nei pazienti adulti con infezione delle vie urinarie complicata (cUTI, urinary tract infection) causata da patogeni Gram-negativi carbapenemi-resistenti.
    E.2.2Secondary objectives of the trial
    Safety of S-649266
    Clinical outcome of treatment with S-649266 or BAT in patients with HAP/VAP/HCAP or BSI/sepsis and cUTI (TOC/EOT).
    Microbiologic outcome of treatment with S-649266 or BAT in patients with either HAP/VAP/HCAP or BSI/sepsis, with cUTI and with bacteremia (EOT/TOC/FU).
    Composite clinical and microbiologic outcome of treatment with S-649266 or BAT in patients with cUTI.
    All-cause mortality at Day 14 and Day 28 in patients with HAP/VAP/HCAP and BSI/sepsis.
    Relationship between the PD parameter %Tf >MIC based on plasma drug concentrations at steady state and the clinical and microbiologic outcomes of treatment with S-649266 in patients with HAP/VAP/HCAP, cUTI, or BSI/sepsis.
    Resource utilization required for the treatment of the study qualifying infection.
    Compare S-649266 with BAT in patients with HAP/VAP/HCAP, cUTI, BSI/sepsis based on the composite endpoint of survival and no change in antibiotic treatment due to lack of therapeutic benefit or drug-related toxicity.
    Sicurezza di S-649266
    Esito clinico del trattamento con S-649266 o BAT in pazienti (Pt) con HAP / VAP /HCAP o BSI / sepsi e cUTI (TOC / EOT).
    Esito microbiologico del trattamento con S-649.266 o BAT nei Pt con HAP / VAP / HCAP o BSI / sepsi, con cUTI e con batteriemia (EOT / TOC / FU).
    Risultato clinico e microbiologico del trattamento con S-649266 o BAT in Pt con cUTI.
    Cause di mortalità al giorno 14 e 28 in pazienti con HAP / VAP / HCAP e BSI / sepsi.
    Relazione tra PD% Tf> MIC basato sulle concentrazioni plasmatiche del farmaco allo stato stazionario e gli esiti clinici e microbiologici di trattamento con S-649.266 in Pt con HAP / VAP / HCAP, Cuti o BSI / sepsi.
    L'utilizzo delle risorse necessarie per il trattamento dell'infezione studio qualificazione.
    Confronto S-649.266 con BAT in Pt con HAP / VAP / HCAP, Cuti BSI / sepsi e non cambiare in trattamento antibiotico a causa della mancanza di benefit terapeutici o tossicità collegata al farmaco.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria:
    Patients who fulfill the following criteria at Screening will be included in the study:
    1. Hospitalized male and female patients, 18 years or older at the time of signing informed consent.
    2. Patients who have provided written informed consent or their informed consent was provided by legal guardian (Note: Country specific rules and local Ethics Committee approval for legal guardian informed consent will determine whether or not and how a patient unable to comprehend or sign the informed consent is allowed to be enrolled in the study).
    3. Patients with clinically documented infection (HAP/VAP/HCAP, cUTI, or BSI/sepsis) caused by a Gram-negative pathogen with evidence of carbapenem resistance.
    4. Patients who have been treated previously with an empiric antibiotic regimen and failed treatment, both clinically and microbiologically, are eligible for the study, if they have an identified carbapenem-resistant,
    Gram-negative pathogen which has either been shown to be nonsusceptible in vitro to each of the antibiotic(s) of the empiric antibiotic regimen or been grown from a culture performed after at least two days of the empiric antibiotic regimen.
    5. Patient is male (no contraception required) or female and meets one of the following criteria:
    •Surgically sterile by hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy or tubal ligation for the purpose of contraception for at least 6 weeks with appropriate documentation of such surgery.
    •Postmenopausal (defined as older than 45 years of age with cessation of regular menstrual periods for 6 months and confirmed by a folliclestimulating hormone level of > 40 mIU/ml, or amenorrhea for at least 12
    months).
    •Of childbearing potential and using combined (estrogen and progestogen) or progestogen-only hormonal contraception associated with inhibition of ovulation (including oral, intravaginal, injectable, implantable, and transdermal contraceptives), or an intrauterine device (IUD), or intrauterine hormone-releasing system (IUS) for the entire duration of the study.
    •Of childbearing potential and practice abstinence as a preferred and usual lifestyle, and agrees to continue practicing abstinence from screening and for the entire duration of the study.
    •Of childbearing potential, whose sole heterosexual partner has been successfully vasectomized and agrees to not have other heterosexual partners for the entire duration of the study.
    6. Patients meeting specific inclusion criteria for each infection site.
    Saranno inclusi nello studio i pazienti che soddisfino i seguenti criteri allo screening:
    1. Pazienti di sesso maschile e femminile ricoverati in ospedale, di età non inferiore a 18 anni al momento della firma del consenso informato.
    2. Pazienti che abbiano fornito il consenso informato scritto o il cui consenso informato sia stato fornito dal tutore legale. (Nota: le condizioni in base alle quali sia consentito o meno, e con quali modalità, arruolare nello studio un paziente non in grado di comprendere o firmare il consenso informato sono definite da norme specifiche per ogni paese e dall'approvazione del consenso informato del tutore da parte del Comitato Etico).
    3. Pazienti con infezione clinicamente documentata (HAP/VAP/HCAP, cUTI o BSI/sepsi) causata da un patogeno Gram-negativo con resistenza dimostrata ai carbapenemi.
    4. I pazienti trattati in precedenza con un regime antibiotico empirico e che non abbiano risposto al trattamento, né clinicamente né microbiologicamente, sono idonei allo studio qualora presentino un patogeno Gram-negativo carbapenemi-resistente , il quale ha anche dimostrato in vitro di non essere suscettibile a ciascuno degli antibiotici del regime antibiotico empirico o di essere cresciuto da una coltura ottenuta dopo almeno 2 giorni di regime antibiotico empirico.
    5. Paziente di sesso maschile (non sono necessari metodi contraccetivi) o di sesso femminile che soddisfano i seguenti criteri:
    • Chirurgicamente sterili a seguito di una isterectomia e/o ooforectomia bilaterale o di una salpingectomia bilaterale o legatura delle tubi a scopo contraccettivo per almeno 6 settimane con adeguata documentazione dell'intervento.
    • In Post-menopausa (definita come maggiori di età maggiore ai 45 anni con cessazione dei cicli mestruali regolari per 6 mesi e confermata dall'analisi dell'ormone follicolo-stimolante di > 40 mIU/mL, o amenorrea da almeno 12 mesi).
    • Potenzialmente fertili che utilizzano metodi contraccetivi ormonali combinati (estrogeno e progesterone) o solo progesterone associati con inibizione dell’ovulazione (che include metodi orali, intravaginali, iniettabili, impiantabili e contraccettivi transdermici), o dispositivo intrauterino (intrauterine device, IUD), o sistema a rilascio ormonale intrauterino (intrauterine hormone-releasing system, IUS) per tutta la durata dello studio.
    • Potenzialmente fertili e che praticano l’astinenza come stile di vita preferito e usuale, e abbiano acconsentito a continuare l’astinenza dallo screening e per l’intera durata dello studio. Potenzialmente fertili, il cui unico partner eterosessuale sia stato vasectomizzato con successo e abbia acconsentito a non avere altri partner eterosessuali per l’intera durata dello studio.
    6. Pazienti che soddisfino specifici criteri di inclusione per ciascuna sede d'infezione.
    E.4Principal exclusion criteria
    1. Patients who have a history of any moderate or severe hypersensitivity or allergic reaction to any ß-lactam (Note: for ß-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment).
    2. Patients who need more than 3 systemic antibiotics as part of BAT for the treatment of the Gram-negative infection (Patients with mixed Grampositive or anaerobic infections may receive appropriate concomitant narrowspectrum antibiotics [eg, vancomycin, linezolid, metronidazole, clindamycin]).
    3. Patients with coinfection caused by invasive aspergillosis, mucormycosis or other highly lethal mold.
    4. Patients who have central nervous system infection (eg, meningitis, brain abscess, shunt infection).
    5. Patients with infection requiring > 3 weeks of antibiotic treatment (eg, bone and joint infection, endocarditis).
    6. Patients with cystic fibrosis or moderate to severe bronchiectasis.
    7. Patients in refractory septic shock defined as persistent hypotension despite adequate fluid resuscitation or despite vasopressive therapy at the time of randomization.
    8. Patients with severe neutropenia, ie, polymorphonuclear neutrophils (PMNs) < 100 cells/µL
    9. Female patients who have a positive pregnancy test at Screening or who are lactating.
    10. Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 30.
    11. Patients who have received a potentially effective antibiotic regimen for the carbapenem-resistant, Gram-negative infection for a continuous duration of more than 24 hours in cUTI, or 36 hours in HAP/VAP/HCAP or BSI/sepsis during the 72 hours leading to Randomization.
    12. Patients with any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data.
    13. Patients who have received another investigational drug or device within 30 days prior to study entry.
    14. Patients who have previously been randomized in this study or received S-649266.
    15. Patients receiving peritoneal dialysis 16. Patients meeting specific exclusion criteria for each infection site (See Diagnosis-Specific Exclusion Criteria).
    1. Pazienti con un'anamnesi documentata di ipersensibilità moderata o grave o di reazione allergica a qualunque ß-lattamico (Nota: per i ß-lattamici, un episodio anamnestico di eruzione cutanea lieve seguito da una nuova esposizione asintomatica non è una controindicazione all'arruolamento).
    2. Pazienti che necessitino di più di 3 antibiotici sistemici nell'ambito della BAT per il trattamento dell'infezione da Gram-negativi (i pazienti con infezioni miste da Gram-positivi o anaerobi possono ricevere adeguati antibiotici concomitanti a spettro ristretto [es. vancomicina, linezolid, metronidazolo, clindamicina]).
    3. Pazienti con coinfezioni causate da forme diffuse di aspergillosi, mucormicosi o da altre muffe ad alta letalità.
    4. Pazienti con infezione del SNC (es. meningite, ascesso cerebrale, infezione dello shunt).
    5. Pazienti con infezione che richieda > 3 settimane di trattamento antibiotico (es. infezione a carico di ossa e articolazioni, endocardite).
    6. Pazienti con fibrosi cistica o bronchiectasia da moderata a grave.
    7. Pazienti con shock settico refrattario definito come ipotensione persistente nonostante il ripristino dei fluidi o una terapia vasopressiva adeguati al momento della randomizzazione.
    8. Pazienti con neutropenia grave, cioè globuli bianchi (GB) < 100 cellule/µl.
    9. Donne con test di gravidanza positivo allo screening o che stiano allattando.
    10. Pazienti con APACHE II > 30.
    11. Pazienti che hanno assunto una terapia antibiotica potenzialmente efficace nei confronti delle infezioni da Gram-negativi carbapenemi-resistenti per un periodo continuativo di più di 24 ore nelle cUTI o di 36 ore nelle HAP/VAP/HCAP o nella BSI/sepsi, nelle 72 ore precedenti la randomizzazione.
    12. Pazienti in condizioni o circostanze che, secondo il parere dello sperimentatore, comprometterebbero la sicurezza del paziente o la qualità dei dati dello studio.
    13. Pazienti che abbiano ricevuto un altro farmaco o dispositivo sperimentale nei 30 giorni precedenti l'ingresso nello studio.
    14. Pazienti che siano stati precedentemente randomizzati in questo studio o che abbiano ricevuto S 649266.
    15. Pazienti che stiano ricevendo dialisi peritoneale.
    16. Pazienti che soddisfino specifici criteri di esclusione per ciascuna sede d'infezione (vedere Criteri di esclusione specifici per la diagnosi).
    E.5 End points
    E.5.1Primary end point(s)
    - Clinical outcome per patient at TOC in patients with HAP/VAP/HCAP or BSI/sepsis.
    - Microbiologic outcome (for Gram-negative pathogen) per patient at TOC in patients with cUTI.
    - Esito clinico per paziente al TOC nei pazienti con HAP / VAP / HCAP o BSI / sepsi;
    - esito microbiologico (per agente patogeno Gram-negativo) per paziente al TOC in pazienti con cUTI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Test of cure (TOC) - EOT + 7 days.
    Prova di cura (TOC) - EOT + 7 giorni.
    E.5.2Secondary end point(s)
    - Clinical outcome per patient at EOT (HAP/VAP/HCAP or BSI/sepsis).
    - Clinical outcome per pathogen at EOT, and TOC (HAP/VAP/HCAP or BSI/sepsis).
    - Clinical outcome per patient/pathogen at EOT, and TOC (cUTI).
    - Microbiologic outcome (for Gram-negative pathogen) per patient/pathogen at EOT, TOC, and FUP (HAP/VAP/HCAP or BSI/sepsis).
    - Microbiologic outcome (for Gram-negative pathogen) per patient at EOT, and FUP (cUTI).
    - Microbiologic outcome (for Gram-negative pathogen) per pathogen at EOT, TOC, and FUP (cUTI).
    -Microbiologic outcome with documented carbapenem-resistant Gramnegative bacteremia (regardless of primary infection diagnosis) at EOT, TOC, and FUP.
    - Composite clinical and microbiologic outcome at EOT, and TOC (cUTI only).
    - All-cause mortality at Day 14 and Day 28 for HAP/VAP/HCAP and BSI/sepsis.
    - Composite endpoint of survival and no change in antibiotic treatment due to either lack of therapeutic benefit or drug-related toxicity at TOC.
    - Survival time (HAP/VAP/HCAP, BSI/sepsis).
    - CPIS parameters at EOT and TOC (HAP/VAP/HCAP only).
    - SOFA Score at EOT, and TOC.
    - Esito clinico per paziente alla fine del trattamento (HAP / VAP / HCAP o BSI / sepsi).
    - Esito clinico per agente patogeno alla fine del trattamento, e TOC (HAP / VAP / HCAP o BSI / sepsi) .
    - Esito clinico per paziente / patogeno alla fine del trattamento, e TOC (cUTI).
    - Esito microbiologica (per agente patogeno Gram-negativi) per paziente / patogeno alla fine del trattamento, TOC, e FUP (HAP / VAP / HCAP o BSI / sepsi).
    - Esito microbiologica (per agente patogeno Gram-negativi) per paziente a EOT, e FUP (cUTI).
    - Esito microbiologica (per agente patogeno Gram-negativi) per agenti patogeni, a EOT, TOC, e FUP (cUTI).
    - Risultato microbiologico con documentata gram negativi resistenti ai carbapenemi batteriemia (a prescindere dalla diagnosi di infezione primaria) alla fine del trattamento, TOC, e FUP.
    - Composito risultato clinico e microbiologico alla fine del trattamento, e TOC (cUTI solo) per tutte le cause di mortalità al giorno 14 e il giorno 28 per HAP / VAP / HCAP e BSI / sepsi.
    - Endpoint composito di sopravvivenza e nessun cambiamento nel trattamento antibiotico dovuta a uno mancanza di beneficio terapeutico o di tossicità legati alla droga a TOC.
    - Il tempo di sopravvivenza (HAP / VAP / HCAP, BSI / sepsi) eCPIS parametri a EOT e TOC (HAP / VAP / HCAP solo) • SOFA punteggio alla fine del trattamento, e TOC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - End of treatment (EOT) - Last day of study therapy.
    - Test of cure (TOC) - EOT + 7 days.
    - Follow-up (FUP) - EOT + 14 days.
    - Fine del trattamento (EOT) .
    - Ultimo giorno di terapia in studio Prova di cura (TOC) - EOT + 7 giorni Follow up (FUP) .
    - EOT + 14 giorni.
    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 Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Guatemala
    Taiwan
    Brazil
    Israel
    Japan
    Korea, Republic of
    Thailand
    United Kingdom
    United States
    Croatia
    France
    Germany
    Greece
    Italy
    Spain
    Türkiye
    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 years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects who could be not able to understand or personally sign the ICF at screening due to their medical conditions. In this case, the process will follow the local country requirements.
    Soggetti che non potrebbero essere in grado di capire o firmare personalmente l’ICF al momento dello screening a causa delle loro condizioni mediche. In questo caso il processo seguirà i requisiti del paese locale.
    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 60
    F.4.2.2In the whole clinical trial 150
    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 withdrawn or discontinued from study treatment should receive additional standard of care antibiotic therapy if in the judgment of the investigator such treatment is clinically indicated.
    I pazienti che si ritirano o che interrompono il trattamento in studio dovrebbero ricevere terapia di cura antibiotica standard se nel giudizio dello sperimentatore questo trattamento è clinicamente adatto.
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
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