EUCTR2019-002207-17-IT进行中（未招募）1 期
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. - D-PLEX-302
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
- 1,600
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 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
- •Patients with one of the two comorbidities Diabetes Mellitus OR BMI=30,
- •One of the following comorbidities : Current/Previous smoking history =30 pack year
- •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 ( see
- •Section 6.3 – CONTRACEPTIVE METHODS)
- •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.
- •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 560
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1040
排除标准
- •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 D-PLEX 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 a highly effective contraceptive method of birth control ( see Section 6.3 – CONTRACEPTIVE METHODS).
- •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.).
研究者
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