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A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison with Imipenem/Cilastatin/Relebactam in Adults with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia (EudraCT No. 2022-000081-18) (EUCTR No. 2022-501952-27-00) (IND No. 146614)

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A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison with Imipenem/Cilastatin/Relebactam in Adults with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia (EudraCT No. 2022-000081-18) (EUCTR No. 2022-501952-27-00) (IND No. 146614)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Imipenem/cilastatin (Primary) ; XNW 4107 (Primary) ; Cilastatin/imipenem/relebactam
  • Indications Bacterial infections; Pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms REITAB-2
  • Sponsors Evopoint Biosciences

    • Most Recent Events

    • 05 Mar 2025 Status changed from recruiting to completed.
    • 06 Mar 2023 Primary and secondary outcome measures amended.
    • 12 Jan 2023 Planned number of patients changed from 380 to 450.

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