D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery

NCT03558984 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: D-PLEX 302
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 3

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.

Conditions

Surgical Site Infection; Sternal Infection; Cardiac Surgery

Keywords

Cardiac; Surgery; Sternotomy; Heart; CABG; Valve-replacement; Aorta-replacement

Outcome Measures

Primary Outcomes (1)

• Sternal Wound Infection rate

  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.

  within 90 days (3 months) post sternotomy for cardiac surgery

Secondary Outcomes (7)

• Hospitalization days

  90 days

• Average ASEPSIS assessment score

  90 days (3 months) post sternotomy

• Number of surgical re-interventions

  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

Other Outcomes (7)

• Overall hospitalization days

  6 months

• Readmission due to Sternal Surgical Site Infection

  90 days (3 months) post sternotomy

• Time to Sternal Wound Infection

  90 days (3 months) post sternotomy

Study Arms (2)

D-PLEX + SOC

EXPERIMENTAL

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.

Drug: D-PLEX; Other: Standard of Care

Standard of Care

OTHER

For subjects randomized to the control arm, the surgical treatment will be as per the SOC.

Other: Standard of Care

Interventions

D-PLEX DRUG

D-PLEX is a new formulation of extended release of Doxycycline (active ingredient)

D-PLEX + SOC

Standard of Care OTHER

The SOC prophylactic antibiotic treatment will be consistent and standardized for all sites in the clinical study. is based on "The society of thoracic surgeons practice guideline series: antibiotic prophylaxis in cardiac surgery, part II: antibiotic choice."

D-PLEX + SOC; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PolyPid Ltd.: lead

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Memorial Hermann

Houston, Texas, 77024, United States

Location

Soroka Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hartzell V. Schaff, M.D.

  Mayo Clinic, 220 First Street SW, Rochester, MN. 55902

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be randomized to either the treatment arm (D-PLEX + SOC prophylactic antibiotic treatment) or to control arm (SOC prophylactic antibiotic treatment only), in a 1:1 ratio. Subjects will be blinded to the study arm.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: December 17, 2019
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (2)