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A Phase II Proof of Concept Multicenter, Randomized, Double-Blind Study to Assess the Safety and Efficacy of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated by DAIR

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Trial Profile

A Phase II Proof of Concept Multicenter, Randomized, Double-Blind Study to Assess the Safety and Efficacy of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated by DAIR

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs PP 1493 (Primary) ; PP 1815 (Primary)
  • Indications Bone and joint infections; Staphylococcal infections
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms GLORIA
  • Sponsors PHAXIAM Therapeutics

    • Most Recent Events

    • 13 Nov 2024 According to a PHAXIAM Therapeutics media release, clearance (CTA) from European and UK (MHRA) regulatory authorities to initiate patient enrollment in Europe.
    • 04 Nov 2024 According to a PHAXIAM Therapeutics media release, after successful completion of GLORIA, expected in Q3 2026, PHAXIAM could be eligible for an early access process and could look for getting Conditional Market Approval (CMA), paving the way for pre-commercialization in Europe as early as the second half of 2027.
    • 04 Nov 2024 According to a PHAXIAM Therapeutics media release, the company is about to finalize the filing of the clinical protocol with the main European health authorities3, including the British MHRA. Subject to these approvals, the GLORIA study will be conducted in 7 European countries (France, Germany, UK, Spain, Italy, Netherlands, Sweden) and the United States, making it the most robust phage therapy study in the world.

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