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

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Meropenem/vaborbactam (Primary)
  • Indications Enterobacteriaceae infections
  • Focus Registrational; Therapeutic Use
  • Acronyms TANGO 2
  • Sponsors Rempex Pharmaceuticals; The Medicines Company
  • Most Recent Events

    • 06 Aug 2017 Status changed from recruiting to completed.
    • 25 Jul 2017 According to The Medicines Company media release, the study protocol will be amended to now enroll patients only into the meropenem-vaborbactam treatment group.
    • 25 Jul 2017 According to The Medicines Company media release, the DSMB concluded that a risk-benefit analysis of available data no longer supported randomization of additional patients to the best available therapy comparator arm. The Company will continue to enroll patients into an amended, single-arm study protocol for treatment with meropenem-vaborbactam at selected sites.
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