EUCTR2020-002325-28-SK进行中（未招募）1 期
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. - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- PolyPid Ltd.
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is > 10cm (target incision).
- •2. Subjects are preoperative hemodynamically stable
- •(BP=180/110 and =90/60 mmHg, and HR=100 and =60 bpm, and temperature =38.50C 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Subjects with suspected/diagnosed intestinal perforation, intraabdominal
- •abscess, or any emergency/urgent colorectal surgery with acute intestinal
- •obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon, diverticulitis,
- •volvulus, ect.)
- •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 abdominal surgery, including concomitant repair of ventral hernia. Salpingo oophorectomy and cholecystectomy are allowed.
- •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 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, other than resectable non metastatic colorectal cancer, that is the reason for the index surgery, or carcinoma in situ (or other cancer in situ = Stage 0), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin, or a malignancy that has not been in complete
- •clinical remission and without maintenance chemo or immunotherapy for at least 3 years.
- •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).
研究者
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