Prospective, Multicenter, Randomized, Parallel Controlled, Two Arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly With the SOC IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- PolyPid Ltd.
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Sternal Wound Infection rate
研究概览
简要总结
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 (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections.
Study to assess D-PLEX efficacy and safety 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.
详细描述
This is Phase III study to evaluate the anti-infective efficacy and safety of D-PLEX, a new formulation of extended release of Doxycycline, over a period of 3 months post operation by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. Study will be conducted in about 45 sites in US (about 15 sites), Europe and Israel, recruitment period will last about 18 months. D-PLEX will be administered as a single application. For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment. For subjects randomized to the control arm, the surgical treatment will be as per the SOC. Pre- and post-operative care for both arms will be performed per site SOC. Patients will followed-up during 6 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will be blinded to the treatment arm assignment. The study site personnel present at the baseline procedure as well as the physician performing the procedure will be trained not to disclose the treatment arm to the subject, his/her family, to health care providers outside of the surgery department and to the study sponsor.
Two independent of the sponsor/investigator committees will be involved in the assessment of study outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable.
- •Males and females.
- •Subjects age of 18 and older.
- •Subjects with both Diabetes Mellitus AND BMI≥30 OR
- •Diabetes Mellitus/BMI≥30 AND at least one of the following:
- •Current/Previous smoking history ≥30 pack year
- •Chronic Obstructive Pulmonary Disease (COPD)
- •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.
- •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.
排除标准
- •Subjects undergoing partial sternotomy.
- •Subjects with any preoperative active significant infection.
- •Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening.
- •Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other study drug ingredients.
- •Subjects with known allergies to more than 3 substances. (An allergy questionnaire will be filled during the screening process).
- •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.
- •Subjects with uncontrolled Asthma (GINA III-IV).
- •Subjects with chronic urticaria.
- •Immunocompromised subjects from any reason, at screening.
- •Subjects with renal failure requiring dialysis.
- •Subjects scheduled to major organ transplantation and/or to other significant concomitant surgical procedure.
- •Subjects scheduled for mechanical assist device.
- •Subjects scheduled to be treated with preventive negative pressure devices.
- •Subjects undergone Cerebro-Vascular Accident (CVA)/Transient Ischemic Attack (TIA) within the past 3 months prior to randomization.
- •Subjects that have undergone previously, any cardiac surgery through sternotomy.
- •Subjects with active or previous malignancy in the chest area.
- •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.
- •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).
- •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).
- •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 Follow-Up visits attendance etc.).
研究组 & 干预措施
D-PLEX + SOC
For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.
干预措施: D-PLEX (Drug)
D-PLEX + SOC
For subjects randomized to the investigational treatment arm, D-PLEX treatment will be applied at the end of the index surgery just before closing the chest, as an adjunct to the SOC prophylactic antibiotic treatment.
干预措施: Standard of Care (Other)
Standard of Care
For subjects randomized to the control arm, the surgical treatment will be as per the SOC.
干预措施: Standard of Care (Other)
结局指标
主要结局
Sternal Wound Infection rate
时间窗: within 90 days (3 months) post sternotomy for cardiac surgery
Infection rate as measured by the proportion of subjects with a sternal wound infection event. Sternal wound infection is composed of Deep Sternal Wound Infection (DSWI) \& Superficial Sternal Wound Infection (SSWI). Mortality from any reason within 90 days (3 months) post sternotomy, will be analyzed as treatment failure.
Number of Participants With a Sternal Wound Infection Event
时间窗: within 90 days (3 months) post sternotomy for cardiac surgery
Sternal infection will be identified by predefined criteria based on modification of the CDC's Criteria for Surgical Site Infection (SSI) \& Surveillance Definition for Specific Types of Infections Chapters, January 2018
次要结局
- Number of surgical re-interventions(90 days (3 months) post sternotomy)
- Hospitalization days(90 days)
- Average ASEPSIS assessment score(90 days (3 months) post sternotomy)
- Superficial Sternal Wound Infections (SSWI)(90 days (3 months) post sternotomy)
- Deep Sternal Wound Infections (DSWI)(90 days (3 months) post sternotomy)
- Determination of susceptibility to Doxycycline(90 days (3 months) post sternotomy)
- Mortality rate associated with Sternal Wound Infection (SWI)(90 days (3 months) post sternotomy)
- Hospitalization Days(within 90 days (3 months) post sternotomy for cardiac surgery)
- Surgical Re-interventions(90 days (3 months) post sternotomy)
- ASEPSIS Assessment Score(90 days (3 month) post sternotomy)