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.

Trial Profile

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.

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Apr 2017

At a glance

  • Drugs Doxycycline (Primary)
  • Indications Mediastinitis
  • Focus Therapeutic Use
  • Sponsors POLYPID
  • Most Recent Events

    • 16 Mar 2017 New trial record
    • 09 Mar 2017 According to a PolyPid media release, Company recently completed a successful pre-Investigational New Drug Application meeting with the FDA in which the Agency agreed that D-PLEX™ can move directly into a Phase III trial in the U.S., based on the satisfactory results from this trial.
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