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
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 12 Nov 2018
At a glance
- Drugs Doxycycline hyclate (Primary) ; Antibacterials
- Indications Postoperative infections
- Focus Therapeutic Use
- Sponsors POLYPID
- 12 Nov 2018 According to a POLYPID media release, the United States Food and Drug Administration (FDA) has completed its review of the IND and indicated that PolyPid may proceed with its phase 3 clinical trial of its lead asset D-PLEX for the prevention of post-cardiac surgery sternal Infections. The clinical trial is expected to start in the first half of 2019.
- 16 Aug 2017 According to a PolyPid media release, company plans to initiate this study in 2018.
- 16 Mar 2017 New trial record