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    Summary
    EudraCT Number:2020-003617-36
    Sponsor's Protocol Code Number:D-PLEX312
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-02-08
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-003617-36
    A.3Full title of the trial
    Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of D-PLEX in prevention of infections following abdominal surgeries.
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection.
    A.4.1Sponsor's protocol code numberD-PLEX312
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04411199
    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 organisationOptimapharm d.o.o.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressUlica Grada Vukovara 284
    B.5.3.2Town/ cityZagreb
    B.5.3.3Post code1000
    B.5.3.4CountryCroatia
    B.5.4Telephone number+38515603600
    B.5.5Fax number+38515603601
    B.5.6E-maildaniela.pirvu@optimapharm.eu
    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 NA
    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.3.9.2Current sponsor codeNA
    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 abdominal surgery incisional infection.
    E.1.1.1Medical condition in easily understood language
    Prevention of post abdominal surgery incisional infection
    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 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
    To assess the anti-infective efficacy of D-PLEX administered concomitantly with the Standard of Care (SoC) over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and/or deep infection, in the target incision, compared to the SoC treated control arm and to assess the safety of D-PLEX administered concomitantly with the Standard of Care (SoC).
    E.2.2Secondary objectives of the trial
    1. Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event only, occurring within 30 days post abdominal (index) surgery and determined by a blinded and independent adjudication committee, in the population of subjects with target incision length >20cm.
    2. Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, in the overall study population (incision ≥7cm). All-cause mortality and re-interventions through the abdominal incision (target) within 30 days post index surgery will be analysed as treatment failure.
    3. Number (percent) of subjects with at least 1 score of ASEPSIS >20, within 30 days post abdominal (index) surgery (population of subjects with target incision length >20cm).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics (PK)
    E.3Principal inclusion criteria
    1. Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is ≥20cm (target incision).
    2. Subjects are preoperative hemodynamically stable. (BP ≤180/110 and ≥90/60 mmHg, and HR ≤120 and ≥60 bpm, and temperature ≤37.50C and ≥35.50C).
    3. Male or non pregnant female.
    4. Female of child bearing potential should have a negative pregnancy test (serum or urine dipstick) prior to index procedure.
    Note: All female subjects of child bearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study (see Section 8.6 CONTRACEPTIVE METHODS).
    5. Subjects' age 18 years old and above at screening.
    6. Subjects who sign the written Informed Consent Form.
    7. Subjects who are willing and able to participate and meet all study requirements.
    8. Survival expectancy of at least 60 days post randomization.
    E.4Principal exclusion criteria
    1. Subjects with suspected/diagnosed intestinal perforation, bowel obstruction, intra abdominal abscess, toxic colitis, ileus/subileus, megacolon, diverticulitis, volvulus.
    2. Subjects who underwent an intra abdominal surgery within the last 6 months prior to randomization.
    3. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, excluding pre operative prophylaxis.
    4. Subjects undergoing concomitant major procedures in addition to the colorectal resection.
    Female sterilization surgeries (i.e. salpingo- oophorectomy etc.), involvement of a small bowel procedure or cholecystoctomy may be allowed, pending an advanced consultation and approval from the Sponsor.
    5. Subjects who received any anti cancer treatment within the last 4 weeks of surgery.
    6. Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, prior to the planned abdominal surgery.
    7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
    8. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D PLEX's excipients.
    9. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
    10. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions.
    11. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
    12. Subjects with severe hepatic impairment.
    13. Subjects with chronic urticaria.
    14. Subjects diagnosed with CVA within the past 6 months prior to randomization.
    15. Subjects who underwent any abdominal surgery and current planned index surgery involves re opening the scar of a prior abdominal surgery performed within the last 3 years.
    16. Any subject with an active malignancy or with malignancy that has not been in complete medical remission and without maintenance chemo or immunotherapy for at least three years. Excluding: Subjects with potentially resectable non metastatic colorectal cancer, that is the reason for the index surgery.
    Subjects who have had carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin.
    Subjects with any additional non-violent cancer that does not require
    treatment 4 weeks prior to the surgery, and throughout the entire study
    duration.
    17. Subjects with other concurrent severe and/or uncontrolled medical condition.
    18. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
    19. Chronic alcoholic or drug abuse subjects.
    20. Pregnant or breast feeding women or women of child bearing age who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow up period.
    21. Subjects who received any investigational drug within 30 days or 5 half lives prior to randomization to the study (whichever is longer) and through the study.
    22. Subjects participating in any other interventional study.
    23. Subjects who in the opinion of Investigator, are not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, in the study population with longer incision (>20cm).
    Abdominal incisional infection is composed defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI).

    All cause mortality and re interventions through the abdominal incision (target) within 30 days post index surgery will be analysed as treatment failure.

    Reintervention is defined as re opening of the same target incision, used for the original index surgery, in the operation room (OR).

    An independent and blinded adjudication committee will review each case suspected for SSI and will adjudicate if meets the SSI endpoint criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    Key endpoints:
    1. Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event only, occurring within 30 days post abdominal (index) surgery and determined by a blinded and independent adjudication committeein the population of subjects with target incision length >20cm.
    2. Infection rate as measured by the proportion of subjects with at least
    one abdominal target incisional infection event, occurring within 30 days
    post abdominal surgery and determined by a blinded and independent
    adjudication committee, in the overall study population (incision ≥7cm).
    All-cause mortality and re-interventions through the abdominal incision
    (target) within 30 days post index surgery will be analysed as treatment
    failure.
    3. Number (percent) of subjects with at least 1 score of ASEPSIS > 20, within 30 days post abdominal (index) surgery (population of subjects with target incision length >20cm).

    Additional endpoints (population of subjects with target incision length
    >20cm):
    ● Incidence of SSSI during 30 days post index surgery.
    ● Incidence of DSSI during 30 days post index surgery.
    ● All-cause mortality rate within 30 days post randomization.
    ● All-cause mortality rate within 60 days post randomization.
    ● Time to adjudicated SSI during 30 days post index surgery.
    ● Number (percent) of subjects re-admitted during 30 days post index-surgery (for any reason) that have experienced adjudicated SSI during this re-admission.
    ● Number (percent) of subjects who experienced at least 1 surgical re-intervention due to adjudicated SSIs during 30 days post index -surgery.

    SSI related Additional Endpoints:
    ● Number (percent) of subjects with adjudicated SSI where at least one Doxycycline-resistant bacteria have grown in bacteriology tests.
    ● Number (percent) of Doxycycline-resistant bacteria out of all bacteria that were cultured during bacteriology test from subjects with adjudicated SSI.
    ● Number (percent) of subjects who experienced adjudicated SSI during 30 days post index-surgery that were treated by IV antibiotic.
    ● Number of IV antibiotic treatment days, administered to subjects who experience adjudicated SSI during 30 days post index surgery.
    ● Average of subjects’ cumulative ASEPSIS assessment score (AUC) for subjects with adjudicated SSI during 30 days.
    ● Number (percent) of subjects with at least 1 score of ASEPSIS > 20 in subject with adjudicated SSI within 30 days post abdominal index surgery.
    Identification of an SSI will be based on CDC/NHSN Patient Safety
    Component Manual criteria (January 2023, chapter 9)
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 60 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 No
    E.8.1.4Double blind Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Bosnia and Herzegovina
    North Macedonia
    Moldova, Republic of
    Israel
    Serbia
    United States
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Portugal
    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 years3
    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 years4
    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: 770
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 330
    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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 1277
    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 abdominal 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 Decision2021-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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