- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02731573
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
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 Primary Sternal Infection Post Cardiac Surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Beer sheva, Israel
- Soroka Medical Center
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Haifa, Israel
- Rambam Medical Center
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Tel Aviv, Israel
- Assuta Medical Center
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Tel Hashomer, Israel
- Sheba Medical Center
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Tiberias, Israel
- Poriya Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment arm
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.
|
D-PLEX will be administered as a single application during the open heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
Subject will undergo open heart surgery according to standard of care
Other Names:
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OTHER: Control arm
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
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Subject will undergo open heart surgery according to standard of care
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Within 90 days post-cardiac surgery.
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Decrease of infection rate as measured by the proportion of subjects with at least 1 identified sternal infection within 90 days post-cardiac surgery.
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Within 90 days post-cardiac surgery.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erez Kachel, MD, Sheba MC
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 (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-PLEX -301 study
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
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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