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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2022-10-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Site Infection Sternal Infection Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

D-PLEX

Intervention Type DRUG

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

Standard of Care

Intervention Type 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."

Standard of Care

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

Group Type OTHER

Standard of Care

Intervention Type 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."

Interventions

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D-PLEX

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

Intervention Type DRUG

Standard of Care

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."

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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. 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)
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 (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study.
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.

Exclusion Criteria

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 study drug ingredients.
5. Subjects with known allergies to more than 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 to major organ transplantation and/or to other significant concomitant surgical procedure.
12. Subjects scheduled for mechanical assist device.
13. Subjects scheduled to be treated with preventive negative pressure devices.
14. Subjects undergone Cerebro-Vascular Accident (CVA)/Transient Ischemic Attack (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 an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide).
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 Follow-Up visits attendance etc.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No