6/28/23, 12:02 AM ADAPT-PO Pathway Feedback Search Clinical Topics Home Studies ADAPT PO ADAPT PO Disease Disease Acute cystitis Acute pyelonephritis Trial question Is tebipenem pivoxil hydrobromide noninferior to ertapenem in patients with complicated UTI? Study design Multi-center Double blinded RCT Population Characteristics of study participants 58.0% female N = 868 42.0% male 868 patients (505 female, 363 male) Inclusion criteria: adult patients with complicated UTI or acute pyelonephritis Key exclusion criteria: confirmed or suspected infection with a carbapenem-resistant pathogen; receipt of > 1 dose of a short-acting antibiotic within 72 hours before randomization; CrCl 30 mL/min; severe hepatic impairment; Interventions N=449 tebipenem pivoxil hydrobromide (oral dose of 600 mg every 8 hours for 7-10 days or 14 days in bacteremia) N=419 ertapenem (intravenous dose of 1g every 24 hours for 7 to 10 days or 14 days in bacteremia) https://web.pathway.md/studies/rec689SFmlYuw72EP 1/2 6/28/23, 12:02 AM ADAPT-PO Pathway Primary outcome Composite outcome of clinical cure and microbiologic response at test-of-cure visit 61.6 % 61.6 58.8 46.2 % 30.8 % Difference not exceeding nonferiority margin 15.4 % 0.0 % Tebipenem pivoxil hydrobromide Ertapenem Difference not exceeding nonferiority margin in composite outcome of clinical cure and microbiologic response at the test-of-cure visit (58.8% vs. 61.6%; ARD -3.3, 95% CI -9.7 to 3.2) Secondary outcomes No significant difference in clinical cure at the test-of-cure visit (93.1% vs. 93.6%; ARD -0.6, 95% CI -4 to 2.8) No significant difference in microbiologic response at the test-of-cure visit (59.5% vs. 63.5%; ARD -4.5, 95% CI -10.8 to 1.9) Significant increase in composite outcome of clinical cure and microbiologic response at the end- of-treatment visit (97.3% vs. 94.5%; AD 2.8%, 95% CI 0.1 to 5.7) Safety outcomes No significant difference in adverse events. Conclusion In adult patients with complicated UTI or acute pyelonephritis, tebipenem pivoxil hydrobromide was noninferior to ertapenem with respect to the composite outcome of clinical cure and microbiologic response at the test-of-cure visit. Reference Paul B Eckburg, Lori Muir, Ian A Critchley et al. Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection. N Engl J Med. 2022 Apr 7;386(14):1327-1338. Open reference URL https://web.pathway.md/studies/rec689SFmlYuw72EP 2/2