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A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Trial Profile

A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2019

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At a glance

  • Drugs Tebipenem pivoxil (Primary) ; Ertapenem
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ADAPT-PO
  • Sponsors Spero Therapeutics
  • Most Recent Events

    • 26 Nov 2019 According to an Spero Therapeutics media release, an overview of the burden of disease in cUTI and the potential for oral SPR994 to change the treatment landscape will be shared as a part of the event in the key opinion leader breakfast symposium in December.
    • 03 Oct 2019 According to a Spero Therapeutics media release, top-line data from this trial is expected in the third quarter of 2020.
    • 03 Oct 2019 According to a Spero Therapeutics media release, The independent review committee reviewed interim plasma concentration data from 33 patients who were randomized to SPR994 following enrollment of the first 70 patients and recommended to continue the trial using the protocol-defined dose without modification.
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