A Phase Ib/II Prospective, Multicenter, Two Part Study; Part 1 - Open Label, Single Arm & Part 2 Randomized, Single-blinded Study to Assess Safety and Efficacy of D-PLEX Concomitantly With Standard of Care vs. Standard of Care Alone in the Prevention of Sternal Infection Post Cardiac Surgery.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PolyPid Ltd.
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- Sternal Infection identified within 90 days post-cardiac surgery. Primary sternal infection as measured by the proportion of subjects with at least 1 identified primary sternal infection within 90 days post-cardiac surgery.
研究概览
简要总结
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized controlled study.
详细描述
D-PLEX is a new formulation of extended controlled release Doxycycline.
Subjects who meet the eligibility criteria and provide signed informed consent, will be enrolled into the study and will be treated with D-PLEX concomitantly with standard of care.
D-PLEX will be administered as a single application during a cardiac surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
The study will assess the efficacy and safety of the controlled release antibiotic (doxycycline) by the reduction in the number of sternal infections observed during the treatment period in any subject above the age of 18 years, including patients with high risk for infection.
Additional follow up for prolonged safety assessments only, will be done as follows until 24 weeks.
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
- Single (Participant)
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
- •Male or non-pregnant female above 18 years old
- •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.
- •Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically.
- •Subjects with (20≤BMI≤40)
- •Subjects who sign a written informed consent.
排除标准
- •Received any investigational drug within 30 days of start of study or within 5½ half-lives (pharmacokinetic or pharmacodynamics) prior to enrollment (whichever is longer).
- •Are ineligible to receive treatment with:
- •Any preoperative active significant infection
- •Antibiotic sensitivity to Doxycycline and/or tetracycline family of drugs
- •Known allergies to more than 3 substances.(Patients should fill the allergy questioners during the enrolment process)
- •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.
- •History of uncontrolled Asthma (GINA III-IV)
- •History of chronic urticaria
- •Pregnant or breastfeeding women.
- •Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening.
- •Subjects who undergo cardiac/open chest surgeries, which are classified as emergency.
- •Immunocompromised subjects from any reason, at screening.
- •Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment.
- •Subjects that previously underwent any cardiac surgery through mid-sternum.
- •In the opinion of investigator, subject is not eligible to participate in the study due to a cognitive status, medical condition or medication status (other than items listed above)
研究组 & 干预措施
D-PLEX + SoC
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
干预措施: Open heart surgery (Procedure)
Standard of Care (SoC)
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
干预措施: Open heart surgery (Procedure)
D-PLEX + SoC
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
干预措施: D-PLEX (Drug)
结局指标
主要结局
Sternal Infection identified within 90 days post-cardiac surgery. Primary sternal infection as measured by the proportion of subjects with at least 1 identified primary sternal infection within 90 days post-cardiac surgery.
时间窗: Within 90 days post-cardiac surgery.
Decrease of infection rate as measured by the proportion of subjects with at least 1 identified sternal infection within 90 days post-cardiac surgery.
Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery.
时间窗: Within 90 days post-cardiac surgery.
The primary endpoint was the decrease in infection rate as measured by the proportion of subjects with at least one identified sternal infection, DSWI (Deep sternal wound infections) and SSWI (Superficial Sternal Wound Infection) within 90 days of post-cardiac surgery. One patient in the Control arm had an SSWI on day 6 post-surgery. The infection was confirmed by a bacteriology test positive for Proteus mirabilis. No subjects in the D-PLEX treatment arm experienced any sternal wound infections and no infection was confirmed during 90 days post-surgery.
次要结局
- Decrease in the Number of Readmissions Due to Sternal Surgical Site Infection(Within 90 days post-cardiac surgery.)
- Decrease in Number of Surgical Re-interventions Due to Sternal Surgical Site Infection.(Within 90 days post-cardiac surgery.)
- Time to Sternal Infection Post-cardiac Surgery.(Within 90 days post-cardiac surgery.)
- Decrease of Sternal Infection Rate, DSWI (Deep Sternal Wound Infections) and SSWI (Superficial Sternal Wound Infection) During the First 30 Days Post Operation.(Within 30 days post operation.)
- Decrease in the Total Number of Sternal Infections, DSWI (Deep Sternal Wound Infections) and SSWI (Superficial Sternal Wound Infection) Between Day 30 and 3 Months.(Between day 30 and 3 months.)
- Decrease in the Number of Hospitalization Days Due to Sternal Surgical Site Infection.(Within 90 days post-cardiac surgery.)