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)
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 07 Jan 2019
At a glance
- Drugs Tebipenem pivoxil (Primary) ; Ertapenem
- Indications Urinary tract infections
- Focus Registrational; Therapeutic Use
- Acronyms ADAPT-PO
- Sponsors Spero Therapeutics
- 07 Jan 2019 According to a Spero Therapeutics media release, the primary endpoint of the pivotal trial will be the combined clinical and microbiological response at the test of cure with a 10% non-inferiority margin versus IV ertapenem. The trial will incorporate a lead-in cohort of 70 patients with intensive pharmacokinetics assessment and data from this cohort is expected in 2H of 2019.
- 07 Jan 2019 According to a Spero Therapeutics media release, the company has submitted an Investigational New Drug (IND) application for SPR994 in cUTI with the FDA and begun startup activities for its ADAPT-PO Phase 3 clinical trial. The Company anticipates opening trial sites to support study enrollment in the first quarter of 2019.
- 07 Jan 2019 According to a Spero Therapeutics media release, based on discussions with the FDA Spero believes that positive results from a single pivotal Phase 3 clinical trial of SPR994 in cUTI demonstrating a 10% non-inferiority margin would support the approval of SPR994 for the treatment of cUTI.