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)

Phase 3 Completed 1372 enrolled Spero Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2019-06-03
Primary completion: 2020-05-20
Completion: 2020-05-27

Outcome

Met primary endpoint

registry analysis (non-inferiority test); TBPM-PI-HBr 600 mg vs Ertapenem 1 g; Risk Difference -3.3 (95% CI -9.7 to 3.2) NCT03788967 ↗

paper CONCLUSIONS: Oral tebipenem pivoxil hydrobromide was noninferior to intravenous ertapenem in the treatment of complicated urinary tract infection and acute pyelonephritis PMID 35388666 ↗

Publications

Eckburg PB, Muir L, Critchley IA, Walpole S, Kwak H, Phelan AM, Moore G, Jain A, Keutzer T, Dane A, Melnick D, Talley AK. Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection. N Engl J Med. 2022 Apr 7;386(14):1327-1338. doi: 10.1056/NEJMoa2105462.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ertapenem	Small molecule	1 g	Intravenous
Subject	TBPM-PI-HBr	Small molecule	300 mg	Oral
Subject	TBPM-PI-HBr	Small molecule	600 mg	Oral