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TERMINATED
NCT03558984
PHASE3

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

Sponsor: PolyPid Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2

Start Date

2019-12-17

Completion Date

2022-10-24

Last Updated

2026-06-30

Healthy Volunteers

No

Interventions

DRUG

D-PLEX

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

OTHER

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."

Locations (3)

Mayo Clinic

Rochester, Minnesota, United States

Memorial Hermann

Huston, Texas, United States

Soroka Medical Center

Beersheba, Israel