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    Summary
    EudraCT Number:2015-005349-29
    Sponsor's Protocol Code Number:CSP.XEL1005
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-28
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2015-005349-29
    A.3Full title of the trial
    Plasma levels of crystalline degradation product 1 (CDP-1) in vancomycin- treated patients with normal or impaired renal function
    Razina kristaliničnog razgradnog proizvoda 1 (KRP-1) u krvnoj plazmi bolesnika s normalnom i bolesnika s oštećenom bubrežnom funkcijom liječenih vankomicinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measurement of levels of degradation product CDP-1 in patients with normal or impaired renal function who are treated with antibiotic vancomycin.
    Mjerenje razina razgradnog proizvoda KRP-1 u bolesnika s normalnim ili oslabljenim radom bubrega koji zbog infekcije trebaju liječenje antibiotikom vankomicinom
    A.4.1Sponsor's protocol code numberCSP.XEL1005
    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 SponsorXellia d.o.o.
    B.1.3.4CountryCroatia
    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 supportXellia d.o.o.
    B.4.2CountryCroatia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynovia Ltd
    B.5.2Functional name of contact pointCT-point
    B.5.3 Address:
    B.5.3.1Street AddressBoškovićeva 3
    B.5.3.2Town/ cityZagreb
    B.5.3.3Post code10000
    B.5.3.4CountryCroatia
    B.5.4Telephone number38514819892
    B.5.5Fax number38514811732
    B.5.6E-mailjacinta.vukovic@synovia-solutions.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 Yes
    D.2.1.1.1Trade name Adimicin
    D.2.1.1.2Name of the Marketing Authorisation holderPliva Hrvatska d.o.o.
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Edicin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    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.IMP: 3
    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 Vankomicin CNP
    D.2.1.1.2Name of the Marketing Authorisation holderCNP Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    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.IMP: 4
    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 Vankomicin PharmaSwiss
    D.2.1.1.2Name of the Marketing Authorisation holderPharmaSwiss d.o.o.
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500000 to 1000000
    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.IMP: 5
    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 Vancomycin Kabi
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500000 to 1000000
    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.IMP: 6
    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 Vankomicin Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500000 to 1000000
    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
    Not applicable: medical conditions or diseases will not be investigated in this trial.
    In this trial pharmacokinetic parameters of vancomycin and its degradation products will be determined in blood plasma of patients treated with vancomycin and the differences in those parameters in patients with normal vs. patients with impaired renal function.
    U ovom ispitivanju se neće pratiti određena bolest ili stanje već će se u bolesnika koji se zbog svoje bolesti liječe vankomicinom određivati razina razgradnih proizvoda u plazmi te utvrđivati razlike istih u bolesnika s normalnom u odnosu an bolesnike s oštećenom funkcijom bubrega
    E.1.1.1Medical condition in easily understood language
    Levels of vancomycin and its degradation products in blood plasma in patients treated with vancomycin will be determined.
    Razina razgradnog proizvoda 1 (KRP-1) u krvnoj plazmi bolesnika s normalnom i bolesnika s oštećenom bubrežnom funkcijom liječenih vankomicinom će se određivati.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To collect information on CDP-1 levels in plasma after repeated IV dosing of vancomycin in patients with normal and impaired kidney function, respectively.
    To explore if there is a difference in systemic exposure to CDP-1, relative to vancomycin, between patients with normal and impaired kidney function.
    Primarni cilj ispitivanja
    Utvrđivanje razina kristaliničnog razgradnog proizvoda 1 (KRP-1) u krvnoj plazmi bolesnika s normalnom i bolesnika s oštećenom bubrežnom funkcijom liječenih vankomicinom.
    Utvrđivanje razlika u sistemskom izlaganju KRP-1, u odnosu na vankomicin, između bolesnika s normalnom i bolesnika s oštećenom funkcijom bubrega.
    E.2.2Secondary objectives of the trial
    not applicable
    nema
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort A:
    - Male or female 18 years of age or older
    - creatinine clearance ≥90 mL/min (estimated using Cockroft-Gault formula),
    - treated with 1 g vancomycin q12h for at least 3 days,
    - provided informed consent.

    Cohort B:
    - Male or female 18 years of age or older
    - creatinine clearance <50 mL/min. (estimated using the Cockroft-Gault formula),
    - not in need of continuous hemofiltration,
    - treated with vancomycin q24h for at least 5 days at a dose which in the Investigator’s opinion corresponds to a dose of 2 g/day in patients with normal renal function,
    - provided informed consent.
    Skupina A:
    - bolesnici oba spola od 18 godina nadalje
    - klirens kreatinina ≥90 mL/min
    - liječenje vankomicinom u dozi od 2g/dan tijekom najmanje 3 dana
    - potpisan informirani pristanak.
    Skupina B:
    - bolesnici oba spola od 18 godina nadalje
    - klirens kreatinina <50 mL/min, bez indicirane kontinuirane hemofiltracije
    - liječenje vankomicinom tijekom najmanje 5 dana u dozi koja po mišljenju ispitivača odgovara dozi od 2 g/dan u bolesnika s urednom bubrežnom funkcijom
    - potpisan informirani pristanak.
    E.4Principal exclusion criteria
    Patients meeting ANY of the following criteria shall not be included into the study.
    1. Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, as evidenced by medical history or positive result of serological testing.
    2. Pregnancy, if evident from medical history.
    3. Class II or III obesity (BMI ≥35).
    4. Treatment with medications which interfere with serum creatinine assay (e.g., barbiturates, cefazolin, ceforanide, cefoxitin, cefpirome, levodopa, methyldopa), or decrease CLCR without effect on glomerular filtration rate (cimetidine, pyrimethamine, trimethoprim) within 1 week prior to screening or during the screening period.
    5. Presence of risk factors which in the Investigator’s opinion may preclude completion of blood sampling according to this protocol.
    Isključni kriteriji
    1. HIV, hepatitis B ili hepatitis C infekcije
    2. Trudnoća
    3. Pretilost III ili IV stupnja(BMI ≥35).
    4. Liječenje lijekovima koji mogu interferirati sa testovima za mjerenje serumskog kreatinina ili lijekovima koji smanjuju serumski kreatinin bez utjecaja na glomerularnu filtraciju tjedan dana prije ispitivanja ili tijekom vremena probira.
    5.Postojanje faktora rizika koji po mišljenju Ispitivača mogu utjecati na uzorkovanje krivi sukladno Planu ispitivanja
    E.5 End points
    E.5.1Primary end point(s)
    -CDP-1 load after IV dosing of vancomycin and CDP-1-to-vancomycin ratio in infusion solution.
    -PK parameters for vancomycin in patients with normal or impaired renal function, respectively, including AUCτ, C max, tmax, C trough and CL from plasma.
    -PK parameters for CDP-1 in patients with normal or impaired renal function, respectively, including AUCτ, C max, tmax, C trough and CL from plasma.
    -Dose-normalized CDP-1 AUCτ in plasma in patients with normal or impaired renal function, respectively.
    -CDP-1 AUCτ relative to vancomycin AUCτ in plasma in patients with normal or impaired renal function, respectively.
    - opterećenja KRP-1 nakon i.v. primjene vankomicina i omjera između KRP-1 i vankomicina u infuzijskoj otopini
    - farmakokinetičkih parametara za vankomicin, uključujući AUCτ, Cmax, tmax, Cmin i klirens iz plazme u bolesnika s normalnom i bolesnika s oštećenom bubrežnom funkcijom
    - farmakokinetičkih parametara za KRP-1 uključujući AUCτ, Cmax, tmax, Cmin i klirens iz plazme u bolesnika s normalnom i bolesnika s oštećenom bubrežnom funkcijom
    -AUCτ za KRP-1 prilagođen dozi u plazmi bolesnika s normalnom i bolesnika s oštećenom bubrežnom funkcijom
    -Odnos AUCτ za KRP-1 i AUCτ za vankomicin u plazmi bolesnika s normalnom i bolesnika s oštećenom bubrežnom funkcijom

    E.5.1.1Timepoint(s) of evaluation of this end point
    9 or 10 Blood samples will be collected based on cohort ( 9 in patients with normal renal function; 10 in patients with impaired renal function): Pre- dose, during infusion (one hour after infusion start), 0 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 8 h, 12 h and 24 h.
    Each blood sample will be immediately centrifuged at 4 °C to obtain plasma. Plasma will be divided into 2 aliquots and stored at -20 °C or below until analysis.
    Ovisno o skupini kojoj pripadaju bolesnicima će se 9 (bolesnici s normalnom bubrežnom funkcijom) ili 10 (bolesnici s oštećenom bubrežnom funkcijom) uzorkovati krv: prije davanja infuzije, za vrijeme trajanja infuzije (1 sat nakon početka infuzije), 0 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 8 h, 12 h i 24 h. Uzorci krvi se trebaju što prije centrifugirati na 4 °C da se odvoji plazma. Plazma se čuva na -20 °C ili nižim temperaturama do analize.
    E.5.2Secondary end point(s)
    not applicable
    nema
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    nema
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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 No
    E.8.2.3Other No
    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 concerned2
    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
    last blood sampling in last patient
    zadnje uzorkovanje krvi u zadnje uključenog bolesnika
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 6
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    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 are hospitalised and trated for any infectious disease or condition requiring vancomycin therapy. The blood sampling (for the study purpose) twill not interfere with the standard treatment and therapy.
    Uzorkovanje krvi za potrebe ispitivanja neće utjecati na liječenje bolesnika. Po završetku uzorkovanja liječenje vankomicinom će se nastaviti sukladno svakodnevnoj medicinskoj praksi.
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-06-30
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