D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Sur… (NCT03558984) | Clinical Trial Compass
TerminatedPhase 3
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Stopped: company prioritization reasons
United States, Israel2 participantsStarted 2019-12-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✓. Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
✓. 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.
✕
What they're measuring
1
Sternal Wound Infection rate
Timeframe: within 90 days (3 months) post sternotomy for cardiac surgery
. 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).