222. Clinical and microbiological outcomes for Enterobacterales uropathogens in the Phase 3 ADAPT-PO Study of oral tebipenem pivoxil hydrobromide

Abstract Background Enterobacterales (ENT) are frequently implicated in complicated urinary tract infection, including acute pyelonephritis (cUTI/AP), with Escherichia coli (EC) being the most prevalent. Extended-spectrum β-lactamase (ESBL)-producing organisms increasing and often coresistant to existing oral antibiotics such as fluoroquinolones (FQ) trimethoprim-sulfamethoxazole (TMP-SMX). Tebipenem pivoxil hyrdrobromide (TBP-PI-HBr) — a novel carbapenem under development was shown be non-inferior IV ertapenem (ETP) treatment of cUTI/AP ADAPT-PO trial. The goal this analysis assess clinical response (CR) by-pathogen microbiological responses (MR) for ENT pathogens, those resistant phenotypes. Methods Phase 3 multinational, double-blind trial evaluating TBP-PI-HBr vs. 1372 hospitalized adult patients cUTI/AP. Patients were randomized 1:1 or 7-10 days. CR MR at test-of-cure (TOC) phenotypes assessed intent-to-treat population (micro-ITT). Results 90.2% micro-ITT infected ENT; EC prevalent (64.2%), followed by Klebsiella pneumoniae (14.3%), Proteus mirabilis (6.7%) Enterobacter cloacae (2.2%). ESBL-positive, FQ non-susceptible (NS) TMP-SMX-R 23.5%, 38.4% 41.8% ENT, respectively. MIC90 vales both TBP ETP against 0.12 µg/mL. At TOC, all 92.7% 94.0%, respectively, 59.7% 65.9%, TOC ESBL positive 87.6% 95.3%, respectively 54.7% 61.6%, Similar rates observed among Conclusion pathogens high similar between groups, subsets. lower translating phenomenon consistent other cUTI trials representing asymptomatic bacteriuria. showed EC, uropathogens, Disclosures Ian A. Critchley, PhD, Spero Therapeutics: Employee|Spero Stocks/Bonds Paul B. Eckburg, MD, AN2 Stocks/Bonds|Spero Advisor/Consultant Lori Muir, B.Sc., Aaron Dane, MSc, Amplyx: Advisor/Consultant|AN2 therapeutics: Advisor/Consultant|Artizan: Advisor/Consultant|Cidara: Advisor/Consultant|ContraFect: Advisor/Consultant|Correvio: Advisor/Consultant|Davolterra: Advisor/Consultant|Destiny Pharma: Advisor/Consultant|Entasis: Advisor/Consultant|F2G Limited: Advisor/Consultant|GSK: Advisor/Consultant|Humanigen: Advisor/Consultant|Kymab: Advisor/Consultant|Modis: Advisor/Consultant|Orca: Advisor/Consultant|Pfizer: Advisor/Consultant|Phico: Advisor/Consultant|Pled Advisor/Consultant|Rare Thyroid: Advisor/Consultant|Roche: Advisor/Consultant|Scynexis: Advisor/Consultant|Sinovent: Advisor/Consultant|Spero Advisor/Consultant|Transcrip: Advisor/Consultant|Venatorx: Gary E. Moore, David Melnick, Angela K. Talley, Stocks/Bonds.