Oral tebipenem pivoxil hydrobromide works against complicated UTI, acute pyelonephritis

Oral tebipenem pivoxil hydrobromide appears to be as good as intravenous ertapenem in the treatment of patients with complicated urinary tract infection (UTI) and acute pyelonephritis, with the two having a similar safety profile, according to data from a phase III study.

The study randomized 1,372 hospitalized adult patients to receive oral tebipenem pivoxil hydrobromide at 600 mg every 8 hours or intravenous ertapenem at 1 g every 24 hours. Treatment was administered for 7–10 days or up to 14 days in patients with bacteraemia.

A total of 868 (63.3 percent) were included in the microbiologic intention-to-treat population, of whom 50.8 percent had complicated UTIs and 49.2 percent had pyelonephritis. The primary efficacy outcome of overall response (defined as a composite of clinical cure and favourable microbiologic response) at a test-of-cure visit on day 19 was observed in 264 of 449 patients (58.8 percent) in the tebipenem pivoxil hydrobromide arm and in 258 of 419 patients (61.6 percent) in the ertapenem arm. The weighted difference of −3.3 percentage points (95 percent confidence interval [CI], −9.7 to 3.2) did not reach the noninferiority margin of 12.5 percent.

Most patients in both groups achieved clinical cure: 93.1 with tebipenem pivoxil hydrobromide and 93.6 percent with ertapenem (weighted difference, −0.6 percentage point, 95 percent CI, −4.0 to 2.8). Microbiologic response failure was frequently observed among asymptomatic patients with recurrent bacteriuria.

Secondary and subgroup analyses were consistent with the results of the primary analysis.

Adverse events (AEs) occurred in 25.7 percent of patients on tebipenem pivoxil hydrobromide and in 25.6 percent of those on ertapenem. The most common AEs were mild diarrhoea and headache.