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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

Trial Profile

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
  • Most Recent Events

    • 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[100] 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
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