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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: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2020

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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

    • 24 Sep 2020 According to a Spero Therapeutics media release, the company will host a key opinion leader (KOL) call to discuss the recently announced positive top-line data from this trial.
    • 08 Sep 2020 According to a Spero Therapeutics media release, results from this study will be presented in detail at future scientific meetings and in publications.
    • 08 Sep 2020 Primary endpoint has been met. (Number of patients with overall response (combined clinical cure plus microbiological eradication) at test-of-cure (TOC) in the micro- intent-to-treat (ITT) populationdescription)
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