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Phase II, Multicentre, Randomized, Controlled, Two Arm, Single Blind Study to Assess Safety and Efficacy of D-PLEX Administered Concomitantly With SOC, Compared to SOC, in Prevention of Post Abdominal Surgery Incisional Infection

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Trial Profile

Phase II, Multicentre, Randomized, Controlled, Two Arm, Single Blind Study to Assess Safety and Efficacy of D-PLEX Administered Concomitantly With SOC, Compared to SOC, in Prevention of Post Abdominal Surgery Incisional Infection

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Oct 2019

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At a glance

  • Drugs Doxycycline hyclate (Primary) ; Cephalosporins; Metronidazole
  • Indications Postoperative infections
  • Focus Therapeutic Use
  • Sponsors POLYPID

    • Most Recent Events

    • 16 Oct 2019 According to a POLYPID media release, based on the result of this study,company intend to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
    • 16 Oct 2019 Results presented in a POLYPID Media Release.
    • 16 Oct 2019 According to a POLYPID media release, primary endpoint (Infection rate as measured by the proportion of subjects with abdominal incisional infection event) has been met.
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