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.

Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Jun 2018

At a glance

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

    • 21 Jun 2018 Status changed from active, no longer recruiting to completed.
    • 16 Oct 2017 Planned End Date changed from 1 Sep 2017 to 1 Mar 2018.
    • 16 Oct 2017 Planned primary completion date changed from 1 Sep 2017 to 1 Nov 2017.
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