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A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of iv or iv/po Omadacycline and iv/po Levofloxacin in the Treatment of Adults With Acute Pyelonephritis.

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Trial Profile

A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of iv or iv/po Omadacycline and iv/po Levofloxacin in the Treatment of Adults With Acute Pyelonephritis.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Dec 2020

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At a glance

  • Drugs Omadacycline (Primary) ; Omadacycline (Primary) ; Levofloxacin; Levofloxacin
  • Indications Pyelonephritis
  • Focus Therapeutic Use
  • Sponsors Paratek Pharmaceuticals

Most Recent Events

  • 25 Oct 2020 Primary endpoint (Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)) has not been met, according to results presented at the IDWeek 2020
  • 25 Oct 2020 Results presented at the IDWeek 2020
  • 21 Oct 2020 According to a Paratek Pharmaceuticals media release, data are being presented at the IDWeek 2020 virtual meeting.

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