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A Multi-Dose, Double-Blind, Double-Dummy, Active Control, Randomized Clinical (Phase II) Study of Two Dosing Regimens of Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis Requiring Hospitalisation

Trial Profile

A Multi-Dose, Double-Blind, Double-Dummy, Active Control, Randomized Clinical (Phase II) Study of Two Dosing Regimens of Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis Requiring Hospitalisation

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Jan 2018

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At a glance

  • Drugs Finafloxacin (Primary) ; Finafloxacin (Primary) ; Ciprofloxacin; Ciprofloxacin
  • Indications Bacterial infections; Pyelonephritis; Urinary tract infections
  • Focus Therapeutic Use
  • Sponsors MerLion Pharmaceuticals
  • Most Recent Events

    • 16 Jan 2018 Results of pooled data from two trials (NCT01928433 and NCT00722735) assessing the clinical efficacy and antibacterial activity of finafloxacin compared with ciprofloxacin in the treatment of uUTI and cUTI/PN, were published in the Antimicrobial Agents and Chemotherapy.
    • 16 Jan 2018 Results (n=266) of pooled data from three trial assessing population pharmacokinetics of finafloxacin in healthy volunteers and patients with complicated urinary tract infections, were published in the Antimicrobial Agents and Chemotherapy.
    • 16 Jan 2018 Results (n=225) assessing efficacy of finafloxacin (administered for 5 or 10 days) compared with ciprofloxacin (10 days) in patients with complicated urinary tract infections or acute pyelonephritis requiring hospitalisation, were published in the Antimicrobial Agents and Chemotherapy.
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