EUCTR2020-002325-28-HU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
- 900
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 a colorectal surgery involving resection, with or without a stoma formation, that includes 1 incision that is > 10cm (target incision).
- •2. Subjects are preoperative hemodynamically stable.
- •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 a 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 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization besides pre-operative prophylaxis or antibiotic for the treatment of the disease that consists the indication for surgery.
- •2. Subjects undergoing concomitant additional major procedures besides abdominal surgery.
- •Female sterilization surgeries (i.e. salpingo-oophorectomy etc.), involvement of a small bowel procedure or cholecystectomy may be allowed, pending an advanced consultation and approval from the Sponsor.
- •3. Subject received anti-cancer treatment within the last 4 weeks of surgery, or radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
- •4. Subjects that received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
- •5. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
- •6. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be filled in during the screening process).
- •7. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or in the opinion of the Investigator the subject is at high risk of developing severe allergic reactions.
- •8. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
- •9. Subjects with chronic urticaria.
- •10. Subjects diagnosed with CVA within the past 6 months prior to randomization.
- •11. Subjects who underwent any abdominal surgery and current planned surgery involves re-opening the scar of a prior abdominal surgery performed within the last 5 years.
- •12. Any subject with active malignancy or with malignancy that has not been in remission for at least 3 years.
- •- Subjects with potentially resectable non-metastatic cancer which consists the indication for the surgery.
- •- Subjects who have had carcinoma in situ (or other cancer in situ = Stage 0), squamous cell carcinoma of the skin and basal cell carcinoma of the skin.
- •- Subjects with any additional non-violent cancer (slowly growing, localized or chronic cancers, that does not require immediate intervention or chemo- or immunotherapy 4 weeks prior to the surgery, and throughout the entire study duration).
- •13. Subjects with other concurrent severe and/or uncontrolled medical condition that could compromise participation in the study.
- •14. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
- •15. Chronic alcoholic or drug abuse subjects.
- •16. Pregnant or breast-feeding women or women of childbearing age who refuse or prohibited of using an effective contraceptive method of birth control throughout study participation, including safety follow-up period.
- •17. Subjects that received any investigational drug within 30 days or 5 half-lives of randomization to the study (whichever is longer).
- •18. Subjects participating in any other interventional studies.
- •19. In the opinion of Investigator, the subject is 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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