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.
Phase of Trial: Phase I/II
Latest Information Update: 30 Jan 2019
At a glance
- Drugs Doxycycline (Primary)
- Indications Mediastinitis
- Focus Therapeutic Use
- Sponsors POLYPID
- 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.