Tebipenem Pivoxil Hydrobromide Noninferior to Ertapenem for UTI
THURSDAY, April 7, 2022 (HealthDay News) -- For patients with complicated urinary tract infection or acute pyelonephritis, tebipenem pivoxil hydrobromide is noninferior to intravenous ertapenem, according to a study published in the April 7 issue of the New England Journal of Medicine.
Paul B. Eckburg, M.D., from Spero Therapeutics in Cambridge, Massachusetts, and colleagues conducted a phase 3, randomized, double-blind, double-dummy, noninferiority trial to examine the efficacy and safety of orally administered tebipenem pivoxil hydrobromide versus intravenous ertapenem in patients with complicated urinary tract infection or acute pyelonephritis. The microbiologic intention-to-treat population included 868 patients: 449 and 419 received tebipenem pivoxil hydrobromide and ertapenem, respectively, for seven to 10 days (or up to 14 days for patients with bacteremia).
The researchers found that 58.8 and 61.6 percent of those receiving tebipenem pivoxil hydrobromide and ertapenem, respectively, had an overall response (weighted difference, −3.3 percent; 95 percent confidence interval, −9.7 to 3.2). At the test-of-cure visit, clinical cure was observed in 93.1 and 93.6 percent of the patients who received tebipenem pivoxil hydrobromide and ertapenem, respectively (weighted difference, −0.6 percent; 95 percent confidence interval, −4.0 to 2.8); most of those with microbiologic response failures were asymptomatic patients with recurrent bacteriuria. Secondary and subgroup analyses supported the primary analysis. Adverse events occurred in 25.7 and 25.6 percent of those who received tebipenem pivoxil hydrobromide and ertapenem, respectively.
"In the absence of other effective oral agents, tebipenem pivoxil hydrobromide may provide an option for the treatment of complicated urinary tract infection and acute pyelonephritis due to antibiotic-resistant uropathogens," the authors write.
The study was funded by Spero Therapeutics, the manufacturer of tebipenem pivoxil hydrobromide.