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A Phase 3, Multi-Center, Randomized, Open-Label Study of Vabomere(Meropenem-vaborbactam) Versus Best Available Therapy in Subjects With Selected Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Trial Profile

A Phase 3, Multi-Center, Randomized, Open-Label Study of Vabomere(Meropenem-vaborbactam) Versus Best Available Therapy in Subjects With Selected Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 May 2019

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At a glance

  • Drugs Meropenem/vaborbactam (Primary)
  • Indications Bacteraemia; Enterobacteriaceae infections; Intra-abdominal infections; Nosocomial pneumonia; Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms TANGO 2; TANGO II
  • Sponsors Rempex Pharmaceuticals; The Medicines Company
  • Most Recent Events

    • 16 May 2019 Results of Post Hoc analysis assessing the efficacy of MV versus best available therapy in the subgroup of patients without prior antimicrobial failure published in the Advances in Therapy.
    • 08 Dec 2018 Taiwan and Spain were planned locations as per Eudra CT record.
    • 01 Dec 2018 Primary endpoint (Proportion of subjects in the mCRE-MITT population with a with a response of Overall Success (cUTI/AP patients)) has been met, as per results published in the Infectious Diseases and Therapy.
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