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    Summary
    EudraCT Number:2019-002207-17
    Sponsor's Protocol Code Number:D-PLEX-302
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-22
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-002207-17
    A.3Full title of the trial
    A Phase III, Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care IV Prophylactic Antibiotic Treatment (SOC) vs. SOC only, in Prevention of Post-Cardiac Surgery Sternal Infections.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of D-PLEX in preventing sternal infection following open heart surgery
    A.4.1Sponsor's protocol code numberD-PLEX-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03558984
    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 SponsorPolyPid Ltd.
    B.1.3.4CountryIsrael
    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 supportPolyPid Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClintec International
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street Address133 Finnieston Street
    B.5.3.2Town/ cityGlasgow
    B.5.3.3Post codeG3 8HB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044141226 1120
    B.5.6E-mail1519POL@clintec.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 nameD-PLEX
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Powder for implantation paste
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXYCYCLINE HYCLATE
    D.3.9.1CAS number 24390-14-5
    D.3.9.3Other descriptive nameDOXYCYCLINE HYCLATE
    D.3.9.4EV Substance CodeSUB01830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.26
    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
    Prevention of Post-Cardiac Surgery Sternal Infections
    E.1.1.1Medical condition in easily understood language
    Prevention of Post-Cardiac Surgery Sternal Infections
    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 10078408
    E.1.2Term Surgical site infection
    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
    • To assess D-PLEX efficacy in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm.
    • To assess D-PLEX safety
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable.
    2. Males and females.
    3. Subjects age of 18 and older.
    4. Patient with the two following comorbidities:
    - Diabetes Mellitus AND BMI≥30
    OR
    Patients with one of the two comorbidities:
    = Diabetes Mellitus OR BMI≥30,
    AND
    One of the following comorbidities :
    = Current/Previous smoking history ≥30 pack year
    OR
    = Chronic Obstructive Pulmonary Disease (COPD).
    5. Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
    Note: All female of childbearing potential must agree to use a highly effective method of contraception (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study.
    6. Subject is willing and able to provide a signed Informed Consent Form and is willing and able to comply with study’s procedures including follow-up visits.
    E.4Principal exclusion criteria
    1. Subjects undergoing partial sternotomy.
    2. Subjects with any preoperative active significant infection.
    3. Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening.
    4. Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other IMP ingredients.
    5. Subjects with known allergies to more than any 3 substances. (An allergy questionnaire will be filled during the screening process).
    6. Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic/hypersensitivity reactions.
    7. Subjects with uncontrolled Asthma (GINA III-IV).
    8. Subjects with chronic urticaria.
    9. Immunocompromised subjects from any reason, at screening.
    10. Subjects with renal failure requiring dialysis.
    11. Subjects scheduled for major organ transplantation and/or to other significant concomitant surgical procedure.
    12. Subjects scheduled for mechanical assist device: left ventricular (LVAD) and/or right ventricular (RVAD), or artificial heart.
    13. Subjects scheduled to be treated with preventive negative pressure devices.
    14. Subjects undergone CVA/TIA within the past 3 months prior to randomization.
    15. Subjects that have undergone previously, any cardiac surgery through sternotomy.
    16. Subjects with active or previous malignancy in the chest area.
    17. Any subject with active malignancy or with malignancy that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell carcinoma of the skin, are eligible.
    18. Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide).
    19. Subjects enrolled in any intervention study with an investigational medicinal product and/or received any investigational medicinal product within 30 days or 5½ half-lives of the product prior to enrollment (whichever is longer).
    20. In the opinion of investigator, subject is not eligible to participate in the study and/or to comply with protocol requirements (e.g. due to a cognitive, medical condition or residency distanced from site that may jeopardize FU visits attendance etc.).
    E.5 End points
    E.5.1Primary end point(s)
    Infection rate as measured by the proportion of subjects with a sternal wound infection event within 90 days (3 months) post sternotomy for cardiac surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints:
    • Average number of Hospitalization days post sternotomy, due to sternal infection.
    • Average ASEPSIS assessment score during 90 days (3 month) post sternotomy.
    • Number of surgical re-intervention due to sternal surgical site infections (including OR and non-OR/bed-side, procedures)

    ‘Other Secondary’ Endpoints (requested by regulators):
    • Incidence of Superficial Sternal Wound Infections (SSWI) during 90 days (3 months) post sternotomy.
    • Incidence of Deep Sternal Wound Infection (DSWI) during 90 days (3 months) post sternotomy.
    • Mortality rate associated with Sternal Wound Infection (SWI) within 90 days (3 month) post sternotomy.
    • Determination of susceptibility to Doxycycline of any organism recovered from a Sternal Surgical Site Infection.

    Additional Secondary Efficacy Endpoints
    • Overall number of hospitalization days, for any reason.
    • Number of readmissions due to Sternal Surgical Site infection.
    • Average number of Antibiotic Treatment (overall IV and other administration modes, e.g. oral) days due to Sternal Surgical Site infection (SSWI & DSWI).
    • Average number of Antibiotic Treatment (IV) days due to Sternal Surgical Site infection (SSWI and DSWI).
    • Time to sternal wound infection (Post Operating Day) post sternotomy.
    • Average number of analgesic treatment days.
    • Pain VAS Score assessment.

    Safety Endpoints
    The following safety parameters will be evaluated during the trial period (6 months):
    • Adverse events, physical examinations & vital signs.
    • Sternum stability, as indication for sternal bone union, will be clinically evaluated by an investigator that was not involved in the surgery, and is blinded to the treatment arm. In case of suspected instability at end of study visit (6 months after surgery), a chest CT (non‐contrast) will be performed.
    • Surgical wound healing will be assessed by physical examination by an investigator, that was not involved in the surgery, and is blinded to the treatment arm. A modified Vancouver Scar Scale will be provided to the blinded investigators to prompt meticulous evaluation of surgical wound healing.
    • Safety laboratory parameters: Routine hematology & chemistry.
    Urinalysis will be collected on screening and thereafter at investigator discretion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 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) 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Standard of Care IV prophylactic Antibiotic Treatment
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    United States
    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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 560
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1040
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1050
    F.4.2.2In the whole clinical trial 1600
    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)
    The product is to be administered on a single occasion prior to surgical wound closure following cardiac surgical procedures.
    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 Decision2020-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-10-24
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