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Phase III, Randomized, Double-Blind, Study Evaluating Efficacy/Safety/Tolerability of Meropenem-Vaborbactam Compared to Piperacillin/Tazobactam in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

Trial Profile

Phase III, Randomized, Double-Blind, Study Evaluating Efficacy/Safety/Tolerability of Meropenem-Vaborbactam Compared to Piperacillin/Tazobactam in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2018

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At a glance

  • Drugs Meropenem/vaborbactam (Primary) ; Levofloxacin; Piperacillin/tazobactam
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms TANGO 1
  • Sponsors Melinta Therapeutics; Rempex Pharmaceuticals
  • Most Recent Events

    • 27 Nov 2018 According to The Medicines Company media release, based on the data from TANGO-1 and TANGO-2 studies, the EMA has approved Vabomere (meropenem and vaborbactam) for use in adult patients with complicated intra-abdominal and urinary tract infections (cUTI), hospital-acquired pneumonia including ventilator associated pneumonia (HAP/VAP), bacteraemia that occurs in association with any of these infections, and infections due to aerobic gram-negative organisms where treatment options are limited.
    • 07 Oct 2018 Results presented at the IDWeek 2018
    • 21 Sep 2018 According to a Melinta Therapeutics media release, the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending Vabomere for approval as a treatment for adult patients with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia including ventilator associated pneumonia, bacteraemia that occurs in association with any of these infections, and infections due to aerobic Gram-negative organisms.
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