NCT03788967

Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

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: Phase 3
• Study type: Interventional
• Enrollment: 1,372 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).

Conditions

• Complicated Urinary Tract Infection
• Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	TBPM-PI-HBr	TBPM-PI-HBr tablets administered orally.
DRUG	Ertapenem	Antibiotic Therapy for cUTI.
DRUG	Dummy Infusion	Dummy intravenous infusion.
DRUG	Dummy tablets	Dummy tablets orally.

Timeline

• Start date: 2019-06-03
• Primary completion: 2020-05-20
• Completion: 2020-05-27
• First posted: 2018-12-28
• Last updated: 2022-07-25
• Results posted: 2022-07-25

Locations

96 sites across 15 countries: United States, Bulgaria, Czechia, Estonia, Georgia, Hungary, Latvia, Moldova, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study