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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

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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