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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

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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: 06 Nov 2021

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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

  • 07 Jun 2021 Results of a population pharmacokinetic analysis using pooled data from two Phase 1 (Rempex501 & Rempex504) and two Phase 3 studies ( TANGO 1 & TANGO 2) published in the Antimicrobial Agents and Chemotherapy
  • 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

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