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    Summary
    EudraCT Number:2013-001596-21
    Sponsor's Protocol Code Number:POL7080-003
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-30
    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 ConcernedGreece - EOF
    A.2EudraCT number2013-001596-21
    A.3Full title of the trial
    A phase II, open-label, multi-center study to assess pharmacokinetics (PK), safety and efficacy of POL7080 co-administered with standard of care (SoC) treatment in patients with ventilator- associated pneumonia (VAP) due to suspected or documented Pseudomonas aeruginosa infection.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study conducted in several hospitals to check the distribution of study medication(POL7080) in the body, and to verify its safety and its capacity to cure when given in addition to standard treatment for patients with pneumonia caused by bacterium Pseudomonas aeruginosa, following artificial ventilation.
    A.3.2Name or abbreviated title of the trial where available
    POL7080-003
    A.4.1Sponsor's protocol code numberPOL7080-003
    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 SponsorPolyphor Ltd
    B.1.3.4CountrySwitzerland
    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 supportPolyphor Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support
    B.5.2Functional name of contact pointNúria Bordas
    B.5.3 Address:
    B.5.3.1Street Addressc/ Consell de Cent 334-336
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493185020029
    B.5.5Fax number+34931850257
    B.5.6E-mailnuria.bordas@tfscro.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 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 namePOL7080
    D.3.2Product code POL7080
    D.3.4Pharmaceutical form 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 INNPOL7080
    D.3.9.1CAS number 944252-63-5
    D.3.9.2Current sponsor codePOL7080
    D.3.9.3Other descriptive namePOL7080
    D.3.9.4EV Substance CodeSUB120823
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 typePOL7080 is a synthetic cyclic peptide consisting of 14 amino acids.
    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
    Ventilator- associated pneumonia due to suspected or documented Pseudomonas aeruginosa infection.
    E.1.1.1Medical condition in easily understood language
    Pneumonia caused by pseudomonas aeruginosa bacterium in patients on artificial ventilation.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065153
    E.1.2Term Ventilator associated pneumonia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective
    ?To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    ?To investigate POL7080 plus SoC for the following parameters:
    a.Safety and tolerability
    b.The efficacy of POL7080 co administered with SoC for the treatment of VAP due to suspected or documented Pseudomonas aeruginosa infection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male* and female** patients ?18 years of age diagnosed with VAP, i.e., pneumonia that arises more than 96 hours after endotracheal intubation documented or suspected to be due to Pseudomonas aeruginosa requiring treatment with SoC anti-pseudomonas antibiotics.
    2.Patients should have a new or progressive pulmonary infiltrates on the chest radiograph attributable to pulmonary infection.
    AND
    any 2 of the following:
    - documented fever, defined as an oral or tympanic temperature greater than or equal to ? 38 degrees Celsius or hypothermia, defined as a core body temperature less than 35 degrees Celsius.
    - an elevated total peripheral white blood cell (WBC) count (WBC greater than 10,000/mm3) or greater than 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with total WBC greater than 1,000/mm.3
    - new onset of expectorated or suctioned respiratory secretion characterized by purulent appearance indicative of bacterial pneumonia.
    AND
    In addition, patients must have Clinical Pulmonary Infection Score of ? 6.
    3.Respiratory specimen taken by endotracheal (ETA) aspirate, suitable for quantitative cultures as well as for performing Gram stain (In addition a rapid diagnosis test will be performed on the baseline ETA from Greece sites, wherever possible).
    4.BAL or mini-BAL sample taken (if there is a medical indication to perform BAL or it is part of the routine protocol in the patient management at the study site for quantitative culture and rapid diagnostic test at baseline).
    5.Venous access available for IV dosing.
    6.Informed consent:
    i.If the patient is unable to comprehend the scope of the trial prior to enrolment due to altered mental status associated with the underlying pneumonia or any other disease: written informed consent to participate in the study must be obtained from the patient?s legally acceptable representative or a relative, as required by national laws, respective regulations and Institutional Review Boards/Independent Ethics Committees/Regional Ethics Boards (IRB/IEC/REB).
    (Written informed consent should be sought from the patient as soon as he/she becomes capable of comprehending the scope of the trial).
    E.4Principal exclusion criteria
    1. Patients with known hypersensitivity to flouroquinolones, carbapenems, cephalosporin, penicillin (beta-lactam antibiotics) or aminoglycoside antibiotics (i.e. all available SoC antibiotics); patients with a clinically significant history of drug allergies and history of anaphylactic reaction and patients with active allergic conditions at the time of screening.
    2. Patients who received more than 24 hours of anti-pseudomonas antibiotic(s) for the current VAP
    3. Female patients who are pregnant or breast feeding;
    4. Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics (volume of distribution), such as:
    i. evidence of active tuberculosis or other mycobacterium infections,
    ii. cystic fibrosis,
    iii. bronchial obstruction,
    iv. post-obstructive pneumonia due to reasons other than chronic obstructive pulmonary disease (COPD),
    v. known or suspected Pneumocystis jiroveci (Pneumocystis carinii) infection,
    vi. granulomatous disease,
    vii. lung cancer or another malignancy metastatic to the lungs,
    viii. acute respiratory distress syndrome (ARDS) with the underlying cause other than pneumonia,
    ix. empyema.
    5. Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score >25.
    6. Presence of septic shock at the time of evaluation for study entry defined as acute occurrence of non-pulmonary organ dysfunctions or acute worsening of chronic non-pulmonary organ dysfunction within the last 48 hours that is not attributable to an alternative process.
    7. History of lung transplant.
    8. Known or suspected Legionella pneumophilia pneumonia; pneumonia caused by Candida spp or Aspergillus spp.
    9. Documented or suspected meningitis, endocarditis, or osteomyelitis.
    10. Patients with impaired renal function [Creatinine Clearance (CrCL) <60 mL/min], patients with increased renal function with CrCL >300 mL/min determined according to Cockroft-Gault formula (Appendix 4).
    11. Patients with significant liver function abnormalities defined as increase in ALT or AST >3 ULN or in bilirubin >2 ULN or other changes in hematology or clinical biochemistry parameters assessed as clinically relevant by the treating physician noted at study baseline.
    12. Patients with known HIV infection with CD4+ cell count < 200/mm3.
    13. Patients with any arrhythmia identified at study baseline or having been diagnosed and/or treated in the last 6 months, which is considered clinically relevant by the treating physician.
    14. Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry.
    15. Patients with clinically relevant burns.
    16. Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent.
    E.5 End points
    E.5.1Primary end point(s)
    The pharmacokinetic characteristics of POL7080 co-administered with SoC during 14 days of treatment in VAP patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 14 days of treatment:
    On day1 prior to first infusion/dose 1 (as close as possible to the start of infusion), during the infusion at +0.5h, + 1.5h, post-infusion at 5, 30 min and 1, 2, 4, 6 hours, just before the infusions of dose 2, dose 3, dose 4, dose 7, dose 10, dose 13, dose 16, dose 19, during infusion of dose 19 at +0.5h, + 1.5h, dose 19 post infusion at 5, 30 min and 1, 2, 4, 6 hours, before the infusions of dose 20, dose 21, dose 22, dose 25, dose 28, dose 31 dose 34, dose 37 and dose 40.
    E.5.2Secondary end point(s)
    Safety and tolerability of POL7080 co-administered with SoC by evaluating adverse events (AEs,) changes in vital signs, physical examination results, blood chemistry and haematology, and ECG parameters.
    Exploratory endpoints include assessment of POL7080 plus SoC for:
    1.Clinical cure.
    Clinical cure on day 10, EOT and TOC will be assessed based on changes in fever, oxygenation, WBC, purulence of sputum/respiratory secretions, pulmonary infiltrate and absence of sputum and or respiratory secretions.
    Clinical cure will be defined as follows:
    ?Resolution of all clinical signs and symptoms of pneumonia [unless there is an alternative reason (other than pneumonia) for persistence of certain symptoms or residual signs ans symptoms of pneumonia that do not require further antimicrobial treatment] and improvement or lack of progression of all abnormalities on chest radiograph and no further antipseudomonal antimicrobial therapy for VAP was necessary after the EOT until TOC.
    2.Proportion of patients assessed as treatment failure approximately 72 hours after the start of therapy. Treatment failure is defined as:
    i.Absence of improvement in PaO2/FiO2 as compared to baseline
    OR
    ii.Worsening of pulmonary infiltrates
    OR
    iii.Development of septic shock* or multiple organ dysfunction syndrome
    *Septic shock is defined as persistant low blood pressure (systolic <90mm of Hg) that is not responding to fluid replacement alone in the presence of signs and symptoms of severe sepsis (Significantly decreased urine output, abrupt change in mental status, decrease in platelet count , difficulty breathing, abnormal heart pumping function and abdominal pain)
    3.Time to defervescence.
    4.Time to improvement in PaO2/FiO2 to >240 as compared to baseline.
    5.Evolution of PCT (Procalcitonin), CRP (C-reactive protein), PSP/reg (Pancreatic stone protein/regenerating protein) or other parameters with respect to baseline.
    6.Time to 2-log reduction of Pseudomonas aeruginosa as compared to baseline and microbiological outcome at TOC.
    7.Improvement of CPIS and SOFA scores as compared to baseline at approximately 72 hours after the start of therapy, day 6, day 10, EOT and TOC.
    8.Number of mechanical ventilator free days until test of cure.
    9.All-cause mortality on 28th study day.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint and exploratory enpoints will be evaluated throughout the study.
    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 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    End of the trail: End of study assessment for the last patient.

    End of study (EOS) is performed (either by telephone if the patient is discharged from the hospital or in person if the patient is still in the hospital) on 16 ± 2 days after EOT to record the survival status of the patient.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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
    Unconcious patients recieving mechanical ventilation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2013-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-23
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