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    Summary
    EudraCT Number:2016-004486-37
    Sponsor's Protocol Code Number:59812
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-004486-37
    A.3Full title of the trial
    FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown Treatment
    Gerandomiseerde gecontroleerde trial naar fosfomycine als alternatieve orale nabehandeling voor E.coli gecompliceerde urineweginfecties
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fosfomycin as stepdown treatment for ascending urinary tract infections
    Fosfomycine als nabehandeling bij opstijgende urineweginfecties
    A.3.2Name or abbreviated title of the trial where available
    FORECAST
    FORECAST
    A.4.1Sponsor's protocol code number59812
    A.5.4Other Identifiers
    Name:Nederlands Trial register (NTR): Number:registration number: 26799
    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 SponsorUniversity Medical Centre Utrecht
    B.1.3.4CountryNetherlands
    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 supportZambon BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointThijs ten Doesschate
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031887569236
    B.5.6E-mailt.tendoesschate@umcutrecht.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Monuril 3000 mg, granulaat voor drank (Generic name: Fosfomycin-trometamol)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 typeAntibacterial medicinal product (antibiotic)
    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 Ciprofloxacine 500 mg, filmomhulde tabletten Ciprofloxacin 500mg, encapsulated tablets
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 typeAntibiotic medicinal product (antibacterial)
    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 and solvent for oral solution
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute febrile urinary tract infection
    Urineweginfectie met systemische symptomen
    E.1.1.1Medical condition in easily understood language
    Ascending urinary tract infection
    Opstijgende urineweginfectie
    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 10046574
    E.1.2Term Urinary tract infection NOS
    E.1.2System Organ Class 100000017512
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046576
    E.1.2Term Urinary tract infection, site not specified
    E.1.2System Organ Class 100000017512
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate non-inferiority of oral fosfomycin-trometamol compared to oral ciprofloxacin as a step-down treatment for E.coli AF-UTI in women for the cumulative incidence of survival and clinical cure (resolution of symptoms) 6-10 days post-treatment.
    Het aantonen van non-inferioriteit van fosfomycine-trometamol ten opzichte van ciprofloxacine als nabehandeling van E.coli urineweginfecties met systemische symptomen voor de cumulatieve incidentie van overleving en klinische genezing 6-10 dagen na het einde van de behandeling.
    E.2.2Secondary objectives of the trial
    1) To demonstrate non-inferiority of oral fosfomycin-trometamol compared to oral ciprofloxacin as a step-down treatment for E.coli AF-UTI in women on microbiological cure 6-10 days post-treatment, the cumulative incidence of early study discontinuation, the cumulative incidence of clinical cure, the cumulative incidence of mortality, ICU admittances, relapses, reinfections, readmissions, additional antibiotic treatment for Urinary Tract Infections (UTI), adverse events, the total days of hospitalisation and days of absenteeism within 30-35 days post-treatment.

    2) to identify associations between patient/disease or treatment variables/and the primary endpoint 6-10 days post-treatment and ICU admission and mortality 30-35 days post-treatment
    1) Het aantonen van non-inferioriteit van fosfomycine-trometamol ten opzichte van ciprofloxacine als nabehandeling van E.coli urineweginfecties met systemische symptomen voor de cumulatieve incidentie van microbiologische genezing en resistentievorming in urinekweken 6-10 dagen na het einde van de behandeling, de overleving en klinische genezing, mortaliteit, Intensive Care opname, heropnames, recidief urineweginfecties , her-urineweginfecties, additioneel antibioticagebruik, vervroegd stoppen van de onderzoeksmedicatie binnen 30-35 dagen na het einde van de behandeling, het totaal aantal dagen ziekenhuisopname of Intensive Care opname en totaal aantal dagen werkverzuim binnen 30-35 dagen na het einde van de behandeling
    3) Het identificeren van associaties tussen patiënt, ziekte of behandeling variabelen en het primaire eindpunt 6-10 dagen na het einde van de behandeling en de secundaire eindpunten IC opname en mortaliteit binnen 30-35 dagen na het einde van de behandeling


    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FORECAST-eco:
    Version 1.0, 27-02-2017
    To determine the development of resistance to ciprofloxacin and fosfomycin and ESBL formation in Enterobacteriaceae in the gut microbioma after using 5-8 days of oral fosfomycin-trometamol or ciprofloxacin as stepdown treatment of AF-UTI

    FORECAST-far:
    Version 1.0, 27-02-2017
    To establish the pharmacokinetic profile of fosfomycin-trometamol (dosed 3gram every 24 hours for 5 till 8 days)
    FORECAST-eco:
    Versie 1.0, 27-02-2017
    Het bepalen van de ontwikkeling van resistentie voor ciprofloxacine, fosfomycine en ESBL formatie binnen Enterobacteriaceae in de darm als gevolg van de behandeling met oraal fosfomycine-trometamol of ciprofloxacine gedurende 5-8 dagen

    FORECAST-far:
    Versie 1.0, 27-02-2017:
    Het vaststellen van het farmacokinetische profiel van fosfomycine-trometamol (gedoseerd als 3gram elke 24 uur gedurende 5 tot 8 dagen)
    E.3Principal inclusion criteria
    -Hospitalised
    -Competent women (≥18 years), able to give informed consent
    -AF-UTI as presumptive diagnosis and primary reason for hospitalisation*
    -Adequate intravenous antibiotic therapy for ≥48 - ≤120 hours**
    -Candidate for safe iv to oral switch as judged by the attending physician
    -Urine (≥104 CFU/ml) OR blood culture obtained within 24 hours before or after admission: Escherichia coli , ciprofloxacin S AND fosfomycin S***

    * Acute Febrile Urinary Tract Infections (AF-UTI) are UTI with at least one of the forthcoming systemic symptoms: fever or low temperature (≥38.0 C ͦ or <36 C ͦ), rigors, delirium or hemodynamic instability as a result of sepsis requiring intravenous fluids AND at least one of the following local symptoms: lower abdominal pain, low back pain, flank pain or costo-vertebral angle pain or tenderness on physical examination, any of the following symptoms of UTI (dysuria, urinary urgency, urinary frequency, suprapubic/pelvic discomfort, macroscopic hematuria, new urinary incontinence or worsening of pre-existing incontinence). The local study investigator determines the presumptive diagnosis as the primary reason for hospitalisation with consultation of the attending physician.
    **Amoxicillin+/-clavulanic acid / 2nd or 3rd cephalosporin/ aminoglycoside/ carbapenem/ fluoroquinolones/ trimethoprim-sulfamethoxazole OR a combination AND in vitro susceptibility of the causative E.coli to at least one of the used agents
    *** If a participating microbiological laboratory only processes urine cultures ≥ 105 CFU/ml, only these will be included. If an urine or blood culture results in another non-E.coli bacteria that requires antibiotic treatment, the patient should be excluded.
    Inclusiecriteria:
    -Ziekenhuisopname
    -Wilsbekwame vrouw (≥ 18 jaar) in staat om informed consent te geven
    -Urineweginfectie met systemische symptomen als werkdiagnose en primaire reden van ziekenhuisopname*
    -Adequate intraveneuze behandeling gedurende ≥48 - ≤120 uur**
    -Kandidaat voor veilige intraveneuze naar orale switch, zoals beoordeeld door de behandelaar
    -Urine (≥10*4 CFU/ml OF bloedkweek verkregen vóór of na 24 uur na opname: Escherichia coli, ciprofloxacine S EN fosfomycine S***

    * urineweginfecties met systemische symptomen: Tenminste één voortkomend systemisch symptoom: koorts of ondertemperatuur (≥38.0 C ͦ or <36 C ͦ), koude rillingen, delirium of hemodynamische instabiliteit ten gevolge van een sepsis, waarvoor vullingsbehoefte EN tenminste één lokaal symptoom: flankpijn, costovertebrale (slag)pijn, onderbuikspijn, lage rugpijn, of klachten ten gevolge van een urineweginfectie (dysurie, aandrang, vaker plassen, suprapubische gevoeligheid, macroscopische hematurie, nieuwe incontinentie of verergering bestaande incontinentie). De lokale onderzoeker bepaalt de werkdiagnose en de primaire reden van opname in overleg met de behandelaar.
    **Amoxicilline+/-clavulaanzuur / 2e or 3e generatie cefalosporine/ aminoglycoside/ carbapenem/ fluoroquinolone/ trimethoprim-sulfamethoxazole OF een combinatie EN in vitro gevoeligheid van de veroorzakende E.coli voor tenminste één van de gebruikte antibiotica
    ***Als een participerend centrum alleen urinekweken verwerkt ≥ 10*5 CFU/ml, dan worden alleen deze geïncludeerd. Als een urinekweek resulteert in een niet-E.coli die antibiotische behandeling behoeft, dan wordt de patiënt ge-excludeerd.

    E.4Principal exclusion criteria
    -Pregnant or nursing women
    -Glomerular filtration rate < 30 ml/min/1,73 m3 or renal replacement therapy
    -Concomitant systemic antibacterial treatment #
    -Ascertained or presumptive hypersensitivity to the active compounds and/or any excipient of the products or to any quinole
    -Participation to any trial with an investigational product involved in the 30 days before the screening visit
    -Every other laboratory result, clinical condition, disease or treatment that, in investigator’s opinion, make the subject non suitable for the study
    -Specific comorbidity or diagnosis##
    -Contraindications/interactions for any of the active compounds or medication ###
    -Patients with inadequate understanding of the study risks or its requirements or unwilling to plan a follow-up visit


    # If prophylactic antibiotic therapy could not be paused during study therapy, the patient should be excluded Except for continuation of prophylactic antibacterial therapy
    ## Renal transplant patients, polycystic kidney disease, neutropenia (<500 /μl), paraplegia, long-term indwelling catheters (placed ≥24 hours before admission), urostomy, ileal loops, double-J catheter, nephrostomy catheter, suprapubic catheter, suspicion/presence of renal abscess, suspicion of septic metastatic foci/endocarditis
    ### Concurrent use of Tizanidin, Clozapin or Theophylline. If pausing or conversion of this medicine disadvantages the participant, she will be excluded. Patients with a history of tendon disease/disorder related to quinolone treatment. Patients with known risk factors for prolongation of the QT interval. Glucose-6-phosphate dehydrogenase deficiency
    Exclusiecriteria:
    -Zwangerschap of lactatie
    -Glomerulaire filtratie snelheid < 30 ml/min/1,73 m3 of niervervangende therapie
    -Gelijktijdige systemische antibacteriele behandeling #
    -Bevestigde of veronderstelde overgevoeligheid voor de actieve stoffen en/of voor de bijproducten of voor een quinolone geneesmiddel
    -Deelname aan aan andere trial met een studie product in de afgelopen 30 dagen voor screening voor deelname
    -Elk laboratorium uitslag, klinische conditie, ziekte of behandeling die, volgens de onderzoeker, een subject ongeschikt maken voor de studie.
    -Specifieke comorbiditeit of diagnose##
    -Contraindicaties/interacties voor een van de actieve stoffen in de medicijnen ###
    -Patiënten die in staat zijn om de studierisico's of benodigdheden te begrijpen of niet bereid zijn om een follow-up afspraak te maken

    # Indien patienten de antibacteriele profylaxe niet kunnen staken tijdens toediening van studiemedicatie, dan dienen ze uitgesloten te worden
    ## Niertransplantatie patiënten, polycysteuze nierziekten, neutropenie (<500 /μl), paraplegie, lange termijn verblijfskatheter (geplaatst ≥24 uur voor opname), urostoma, dubbel J katheter, nefrostomie katheter, suprapubische katheter, verdenking/aanwezigheid van nierabces, (verdenking) van metastatische foci, endocarditis.
    ### Gelijktijdig gebruik van Tizanidine, Clozapine of Teofylline: als pauzeren of conversie van dit medicijn de participant benadeeld, dan leidt dit tot exclusie. Patiënten met een voorgeschiedenis van peesproblemen gerelateerd aan quinolone gebruik. Patiënten met bekende risicofactoren voor een verlengde QT interval. Glucose-6-fosfaat dehydrogenase deficiëntie.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    The primary endpoint is the cumulative incidence of clinical cure (resolution of symptoms, incl. survival)

    Primaire eindpunt:
    Het primaire eindpunt is de cumulatieve incidentie klinische genezing (resolutie van symptomen, incl. overleving)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6-10 days post-treatment
    6-10 dagen na het einde van de behandeling
    E.5.2Secondary end point(s)
    Secondary endpoints:
    1. The cumulative incidence of microbiological cure 6-10 days post-treatment
    2. The cumulative incidence of survival AND clinical cure (resolution of symptoms) AND microbiological cure 6-10 days post-treatment
    3. The cumulative incidence of acquired fosfomycin resistance, ciprofloxacin resistance or ESBL-producing bacteria in urine culture 6-10 days post-treatment
    4. The cumulative incidence of survival and clinical cure (resolution of symptoms) 30-35 days post-treatment
    5. The cumulative incidence of mortality for any reason or related to UTI or study medicines within 30-35 days post-treatment
    6. The cumulative incidence of ICU admissions for any reason or related to UTI or study medicines within 30-35 days post-treatment
    7. The cumulative incidence of readmissions for any reason or related to UTI or study medicines within 30-35 days post-treatment
    8. The cumulative incidence of relapses within 30-35 days post-treatment
    9. The cumulative incidence of reinfections within 30-35 days post-treatment
    10. The cumulative incidence of additional antibiotic use for UTI within 30-35 days post-treatment
    11. The cumulative incidence of early discontinuation of study medicines because of adverse events OR because of loss of complaints
    12. Total days of hospitalisation and Intensive Care Unit stay within 30-35 days post-treatment
    13. The cumulative incidence of absenteeism within 30-35 days post-treatment
    14. The cumulative incidence of study protocol related and unrelated adverse events, within 30-35 days post-treatment
    15. Patient characteristics associated with the primary or secondary outcomes in both study arms (Charlson comorbidity index, Diabetes Mellitus y/n, indwelling catheter y/n, age </≥ 65 years, treatment restrictions at admission y/n, treatment restrictions at randomisation y/n, renal stones y/n)
    16. Disease related characteristics associated with the primary or secondary outcomes in both study arms (systemic symptoms, ICU admission before iv-oral switch, local symptoms, bacteraemia y/n, time being afebrile before iv-oral switch, CRP, kreatinin, WBC at admission)
    17. Treatment related characteristics associated with the primary or secondary outcomes in both study arms (duration of oral treatment, compliance, duration, name and dose empirical intravenous antibiotic treatment)
    Secundaire eindpunten:
    1. Cumulatieve incidentie van microbiologische genezing 6-10 dagen na het einde van de behandeling
    2. Cumulatieve incidentie van overleving en klinische genezing EN microbiologische genezing 6-10 dagen na het einde van de behandeling
    3. Cumulatieve incidentie van verkregen resistentie voor fosfomycine, ciprofloxacine of ESBL producerende bacterien in urinekweken 6-10 dagen na het einde van de behandeling
    4. Cumulatieve incidentie van overleving en klinische genezing 30-35 dagen na het einde van de behandeling.
    5. Cumulatieve incidentie van mortaliteit door alle oorzaken of gerelateerd aan urineweginfecties of studiemedicijnen binnen 30-35 dagen na het einde van de behandeling.
    6. Cumulatieve incidentie van Intensive Care opname door alle oorzaken of gerelateerd aan urineweginfecties of studiemedicijnen binnen 30-35 dagen na het einde van de behandeling.
    7. Cumulatieve incidentie van heropnames door alle oorzaken of gerelateerd aan urineweginfecties of studiemedicijnen binnen 30-35 dagen na het einde van de behandeling.
    8. Cumulatieve incidentie van recidief urineweginfecties (veroorzaker fenotypisch identiek aan initiële E.coli) binnen 30-35 dagen na het einde van de behandeling.
    9. Cumulatieve incidentie van her-urineweginfecties (veroorzaker fenotypisch verschillend van initiële E.coli) binnen 30-35 dagen na het einde van de behandeling.
    10. Cumulatieve incidentie van additioneel antibioticagebruik voor een urineweginfectie binnen 30-35 dagen na het einde van de behandeling.
    11. Cumulatieve incidentie van gerelateerde en niet gerelateerde bijwerkingen binnen 30-35 dagen na het einde van de behandeling
    12. Cumulatieve incidentie van vervroegd stoppen van de onderzoeksmedicatie ten gevolgen van bijwerkingen of ten gevolge van afwezigheid van klachten
    13. Totaal aantal dagen ziekenhuisopname of Intensive Care opname binnen 30-35 dagen na het einde van de behandeling
    14. Totaal aantal dagen werkverzuim binnen 30-35 dagen na het einde van de behandeling
    15. Patiënt variabelen geaccocieerd met de primaire of secundaire eindpunten in beide armen (Charlson comorbiditeit index, Diabetes Mellitus j/n, urinekatheter j/n, leeftijd </≥ 65 jaar, behandelbeperking tijdens opname j/n, behandelbeperking tijdens randomisatie j/n, nierstenen j/n)
    16. Ziekte variabelen geaccocieerd met de primaire of secundaire eindpunten in beide armen (systemsche symptomen, IC opname voorafgaand aan randomisatie, lokale symptomen, tijd koortsvrij voor randomisatie, CRP, kreatinine en leucocytengehalte tijdens opname)
    17. Behandeling variabelen geaccocieerd met de primaire of secundaire eindpunten in beide armen (duur orale behandeling, compliantie, duur, naam, duur en dosis empirische therapie)

    E.5.2.1Timepoint(s) of evaluation of this end point
    -6-10 days post-treatment
    -within 30-35 days post-treatment
    -6-10 dagen na het einde van de behandeling
    -30-35 dagen na het einde van de behandeling.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Ecological
    Ecologisch
    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 No
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dubbel-dummy
    Double dummy
    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 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
    Last visit of the last subject undergoing the trial
    Laatste visite van de laatste deelnemer van de trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-08-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    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)
    After the subject has ended the participation in the trial the further treatment will not be different from the expected normal treatment. Patients will be deblinded after the trial is completed.
    Nadat de deelnemer aan de trial heeft deelgenomen, zal de behandeling niet anders zijn dan de normaal te verwachten behandeling. Patiënten worden gedeblindeerd nadat de trial is afgerondt.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SION, Stichting Infectieziekten Onderzoek
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
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