- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558984
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Beer Sheva, Israel
- Soroka Medical Center
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
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Texas
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Houston, Texas, United States, 77024
- Memorial Hermann
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- 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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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.
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D-PLEX is a new formulation of extended release of Doxycycline (active ingredient)
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."
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OTHER: Standard of Care
For subjects randomized to the control arm, the surgical treatment will be as per the SOC.
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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."
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sternal Wound Infection rate
Time Frame: within 90 days (3 months) post sternotomy for cardiac surgery
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalization days
Time Frame: 90 days
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Average number of Hospitalization days post sternotomy due to sternal infection.
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90 days
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Average ASEPSIS assessment score
Time Frame: 90 days (3 months) post sternotomy
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ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay duration as inpatient), for wound assessment and treatment parameters, which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of infections. |
90 days (3 months) post sternotomy
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Number of surgical re-interventions
Time Frame: 90 days (3 months) post sternotomy
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Number of surgical re-intervention due to sternal surgical site infection.
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90 days (3 months) post sternotomy
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Superficial Sternal Wound Infections (SSWI)
Time Frame: 90 days (3 months) post sternotomy
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Incidence of Superficial Sternal Wound Infections (SSWI)
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90 days (3 months) post sternotomy
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Deep Sternal Wound Infections (DSWI)
Time Frame: 90 days (3 months) post sternotomy
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Incidence of Deep Sternal Wound Infections (DSWI)
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90 days (3 months) post sternotomy
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Mortality rate associated with Sternal Wound Infection (SWI)
Time Frame: 90 days (3 months) post sternotomy
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Mortality rate associated with Sternal Wound Infection (SWI)
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90 days (3 months) post sternotomy
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Determination of susceptibility to Doxycycline
Time Frame: 90 days (3 months) post sternotomy
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Determination of susceptibility to Doxycycline of any organism recovered from a Sternal Surgical Site Infection.
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90 days (3 months) post sternotomy
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall hospitalization days
Time Frame: 6 months
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Overall Hospitalization days, for any reason.
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6 months
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Readmission due to Sternal Surgical Site Infection
Time Frame: 90 days (3 months) post sternotomy
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Number of readmissions due to Sternal Surgical Site Infection
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90 days (3 months) post sternotomy
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Time to Sternal Wound Infection
Time Frame: 90 days (3 months) post sternotomy
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Time to sternal wound infection (Post Operating Day) post sternotomy.
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90 days (3 months) post sternotomy
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Analgesic treatment
Time Frame: 6 months
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Average number of analgesic treatment days
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6 months
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Visual Analogue Score (VAS) assessment
Time Frame: 6 months
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VAS score assessment, self-completed by the respondent, from 0 (no pain) to 10 (worst imaginable pain)
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6 months
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Antibiotic treatment due to Sternal Surgical Site Infections (all routes of administration).
Time Frame: 90 days (3 months) post sternotomy
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Average number of Antibiotic Treatment (overall IV and other administration modes, e.g.
oral) days due to sternal Surgical Site Infection (SSWI & DSWI)
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90 days (3 months) post sternotomy
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Antibiotic treatment due to Sternal Surgical Site Infections (IV administration).
Time Frame: 90 days (3 months) post sternotomy
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Average number of Antibiotic Treatment (IV administration) days due to sternal Surgical Site Infection (SSWI & DSWI)
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90 days (3 months) post sternotomy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hartzell V. Schaff, M.D., Mayo Clinic, 220 First Street SW, Rochester, MN. 55902
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-PLEX 302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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