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
Overview
- Phase
- Phase 3
- Intervention
- D-PLEX
- Conditions
- Surgical Site Infection
- Sponsor
- PolyPid Ltd.
- Enrollment
- 2
- Locations
- 3
- Primary Endpoint
- Sternal Wound Infection rate
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: D-PLEX
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.
Intervention: Standard of Care
Standard of Care
For subjects randomized to the control arm, the surgical treatment will be as per the SOC.
Intervention: Standard of Care
Outcomes
Primary Outcomes
Sternal Wound Infection rate
Time Frame: 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.
Secondary Outcomes
- 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)