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    Summary
    EudraCT Number:2016-002195-27
    Sponsor's Protocol Code Number:AC101
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedEstonia - SAM
    A.2EudraCT number2016-002195-27
    A.3Full title of the trial
    Pharmacokinetics and tissue penetration of amoxicillin/clavulanic acid in patients with sepsis and septic shock
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Amoxicillin/clavulanic acid in sepsis and septic shock
    A.4.1Sponsor's protocol code numberAC101
    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 of Tartu
    B.1.3.4CountryEstonia
    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 supportUniversity of Tartu
    B.4.2CountryEstonia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTartu University
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressPuusepa 8
    B.5.3.2Town/ cityTartu
    B.5.3.3Post code51014
    B.5.3.4CountryEstonia
    B.5.4Telephone number+3727318412
    B.5.6E-mailkadri.tamme@kliinikum.ee
    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.2.1.2Country which granted the Marketing AuthorisationEstonia
    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 nameAmoksiklav
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 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
    Sepsis and septic shock
    E.1.1.1Medical condition in easily understood language
    Sepsis and septic shock
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 describe the PK of amoxicillin and clavulanic acid in the plasma and in in the subcutaneous tissue of adult patients with sepsis and septic shock.
    E.2.2Secondary objectives of the trial
    To describe the effect of tissue perfusion on the tissue concentrations of amoxicillin and clavulanic acid in adult patients with sepsis and septic shock.
    To assess the adequacy of current dosing regimens, relating the measured plasma and tissue concentrations to minimal inhibitory concentrations of susceptible and intermediately susceptible causative pathogens.
    To assess the safety profile of amoxicillin and clavulanic acid in adult patients with sepsis and septic shock.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study inclusion criteria:
    1) Age 18 years
    2) Sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)1:
    1. Sepsis - life-threatening organ dysfunction caused by a dysregulated host response to infection; that is suspected or documented infection and an acute increase of ≥2 SOFA points (a proxy for organ dysfunction)
    2. Septic shock - sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥65mmHg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation.
    3) Antibacterial treatment with amoxicillin/clavulanic acid in the dose of 1.2g every 8 hours prescribed by the treating physician
    4) Informed consent given by the patient or next of kin
    Arterial catheter in place on clinical indication
    E.4Principal exclusion criteria
    Study exclusion criteria:
    1) Necessity of renal replacemen??t therapy
    2) History of allergic reaction to amoxicillin or other penicillins
    3) Absence of an arterial catheter
    Absence of informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Pharmakokinetic parameters of IMPs (T1/2; Cmax, Cmin, AUC0-8, T above MIC; serum and tissue concentrations)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples for amoxicillin and clavulanic acid plasma concentration measurements will be drawn before and immediately after the end amoxicillin/clavulanic acid infusion and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7 and 8 hours after the start of the 2nd and 5th dose administration.
    Microdialysis. Two baseline samples will be taken before the second and fifth planned amoxicillin/clavulanic acid dose. Microdialysis samples will be collected as follows: approximately 20, 40 min, 1, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 and 8 h after the start of the 2nd and 5th dose administration.
    Urine samples will be taken 2 hours, 4 hours and 8 hours after administration of the 2nd and 5th dose of amoxicillin/clavulanic acid.
    E.5.2Secondary end point(s)
    Adequacy of plasma and tissue concentrations in relation to MIC of causative pathogens
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours after the administration of the first dose of the IMP
    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 Yes
    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) 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 No
    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 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
    LVLS
    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 months
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients may be unable to give consent due to their critical illness and/or sedatives being used. In such cases, consent is acquired from the next of kin.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    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)
    Normal treatment
    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 Decision2016-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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