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    Summary
    EudraCT Number:2018-000653-45
    Sponsor's Protocol Code Number:Fosfo1.0
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-06
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-000653-45
    A.3Full title of the trial
    Pharmacokinetics of a novel extended infusion regimen of fosfomycin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics of a novel extended infusion regimen of fosfomycin
    A.3.2Name or abbreviated title of the trial where available
    Fosfo
    A.4.1Sponsor's protocol code numberFosfo1.0
    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 SponsorDepartment of Clinical Pharmacology, Medical University of Vienna
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDepartment of Clinical Pharmacology, MUV
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Clinical Pharmacology
    B.5.2Functional name of contact pointOffice
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number004314040029810
    B.5.5Fax number004314040029980
    B.5.6E-mailklin-pharmakologie@meduniwien.ac.at
    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 Fosfomycin
    D.2.1.1.2Name of the Marketing Authorisation holderInfectopharm
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNFosfomycin
    D.3.9.1CAS number 26016-99-9
    D.3.9.2Current sponsor codeFosfo
    D.3.9.3Other descriptive nameFOSFOMYCIN DISODIUM
    D.3.9.4EV Substance CodeSUB127116
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    infections with fosfomycin-susceptible organisms e.g. bacteremia, soft tissue infections, central nervous system infections, endocarditis, abscesses etc.
    E.1.1.1Medical condition in easily understood language
    infections with bacteria susceptible to fosfomycin
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10060945
    E.1.2Term Bacterial infection
    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
    PART A: to determine pharmacokinetics of fosfomycin in plasma of healthy volunteers receving fosfomycin both as intermittent and continuous infusion in a crossover fashion
    PART B: to determine pharmacokinetics of fosfomycin in plasma and ELF of critically ill patients receiving fosfomycin as continuous infusion
    E.2.2Secondary objectives of the trial
    PART A:
    • Analysis of pharmacokinetic/pharmacodynamic (PK/PD) targets considering currently established/discussed breakpoints
    • Probability of target attainment (PTA) analysis for different pathogens (in collaboration)
    • Safety and tolerability of both modes of administration

    PART B:
    • Analysis of pharmacokinetic/pharmacodynamic (PK/PD) targets and comparison to currently established/discussed breakpoints
    • Probability of target attainment (PTA) analysis for different pathogens (in collaboration).
    • Collection of safety data regarding continuously administered fosfomycin.
    Exploratory: assessment of clinical cure rate and microbiological cure rate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PART A:
    • Healthy males aged between 18 and 50 years
    • Body mass index between 18 and 30
    • No regular medication within the last 2 weeks prior to the first study day
    • Written informed consent given by volunteers after being provided detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug
    • Willingness to adhere to adequate contraception measures for the entire duration of the study until one month has elapsed from end-of-study visit
    • No legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study

    PART B:
    • Age above 18 years
    • Intubated patients admitted to an intensive care unit of the Vienna general hospital (AKH) participating in this study
    • Sequential organ failure assessment (SOFA) score > 6 at study inclusion
    • Body mass index (calculated from measured or estimated body weight and height) between 18 and 40
    • Indication for treatment with fosfomycin at a total daily dose of 24g (at the discretion of the treating physicians)
    E.4Principal exclusion criteria
    PART A:
    • Known allergy or hypersensitivity against study drug
    • History of severe allergic or anaphylactic reactions to any medication
    • Blood donation within the last 4 weeks prior to study
    • Participation in another clinical study within the last 4 weeks prior to study
    • Alcohol or drug abuse
    • Smoker
    • Abnormalities in ECG including corrected QT interval, laboratory tests or physical examination that are considered clinically relevant (up to investigators judgement) at screening
    • History or presence of significant disease state(s) incompatible with study participation in the judgment of the investigators
    • Sero-positivity for human immunodeficiency virus (HIV) at screening
    • Sero-positivity for hepatitis B or C virus (HepB antigen, HepC antibody) at screening
    • Unreliability and/or lack of cooperation
    • Other objections to participate in the study in the opinion of the investigator

    PART B:
    • Known allergy or hypersensitivity against study drug
    • Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
    • Impaired renal function denoted by an estimated GFR of <40 mL/min according to Cockroft-Gault at study inclusion
    • Requiring hemofiltration or hemodialysis
    • Pregnancy
    • Other factors that preclude study participation in the opinion of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Area under the plasma concentration time curve (AUC) from 0 to 24 hours (AUC0-24) calculated by multiplying AUC0-8 (as determined in part A, study period I) times three and calculated by multiplying steady-state concentrations under continuous infusion times 24 (in part A, study period II as well as in part B)
    E.5.1.1Timepoint(s) of evaluation of this end point
    on study days
    E.5.2Secondary end point(s)
    -Maximum concentration (Cmax), time to maximum concentration (tmax), half-life (t1/2), total body clearance (CL), apparent volume of distribution (VD), concentration during therapy and at defined points after end of therapy (Cx) in plasma (PARTs A and B) or ELF (PART B), respectively.
    -PK/PD relationships: ratio of AUC from 0 to 24 hours to the minimum inhibitory concentration (AUC0-24/MIC); percentage of the dosing interval during which drug concentrations exceed the MIC (%T>MIC); ratio of the peak concentration to the MIC (Cmax/MIC)
    -probability of target attainment (PTA) analysis for relevant pathogens (collaboration)
    -collection of adverse events during study participation

    Exploratory endpoints (PART B only):
    Clinical cure rate (CCR) and (in case a pathogen that is susceptible to fosfomycin was isolated before initiation of fosfomycin treatment) microbiological cure rate (MCR) will be assessed in an exploratory way.
    E.5.2.1Timepoint(s) of evaluation of this end point
    on study days
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic trial
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    same drug, other infusion regimen
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    * adverse events so serious that the resulting risk-benefit ratio becomes unacceptable
    * large numer of drop-outs
    * If the results of parallel clinical trials reveal unacceptable risks
    * If results of any interim analyses and the status of drug development should change, such that the trial would not longer be a necessary part of the clinical program
    * Attempted or proven fraud
    * Slow recruitment
    * Poor quality of data
    * Non-compliance with protocol.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 18
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 2018-03-06. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    in part B of this study, patients might be intubated and sedated at the time of study inclusion
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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)
    none
    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 Decision2018-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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