SHM Converge Scientific Abstract ePoster Gallery-Oral Tebipenem Pivoxil Is Non-Inferior to Iv Ertapenem in Complicated Urinary Tract Infection (Cuti) and Acute Pyelonephritis (Ap): Adapt-Po Study

Oral Tebipenem Pivoxil Is Non-Inferior to Iv Ertapenem in Complicated Urinary Tract Infection (Cuti) and Acute Pyelonephritis (Ap): Adapt-Po Study

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The ADAPT-PO phase 3 study evaluated oral tebipenem pivoxil hydrobromide (TBP-PI-HBr), an investigational oral carbapenem, versus intravenous ertapenem for hospitalized adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP). This global, double-blind, double-dummy trial randomized 1,372 patients to TBP-PI-HBr 600 mg orally every 8 hours or ertapenem 1 g IV daily for 7–10 days (up to 14 days if bacteremic).<br /><br />Patients were well balanced between groups in age, sex, diagnosis, and baseline characteristics. About half had AP and half cUTI, and most infections were caused by Enterobacterales, with substantial rates of resistant phenotypes such as ESBL and fluoroquinolone non-susceptibility.<br /><br />The primary endpoint was overall response at test-of-cure, defined as a composite of clinical cure and microbiologic eradication in the microbiological intent-to-treat population. TBP-PI-HBr met the non-inferiority criterion versus ertapenem. Overall response rates were similar, with approximately 59% in the oral tebipenem group and 62% in the ertapenem group. Clinical improvement exceeded 97% in both groups by end of treatment, and end-of-treatment overall response was 94% in both arms. Responses remained comparable at follow-up.<br /><br />Safety was also similar between treatments. Treatment-emergent adverse events occurred in about 26% of patients in each group, most commonly diarrhea, headache, and nausea. Serious adverse events were uncommon, and no deaths occurred. Discontinuation due to adverse events was rare.<br /><br />In summary, oral TBP-PI-HBr showed non-inferior efficacy and comparable safety to IV ertapenem, suggesting it may offer a potential oral treatment option for cUTI and AP, including infections caused by resistant gram-negative pathogens.

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Angela Talley

Meta Tag

Author List Aaron Dane, Akash Jain, Angela Talley, Anne-Marie Phalen, David Melnick, Gary Moore, Hanna Kwak, Ian Critchley, Lori Muir, Patricia Warfel, Paul Eckburg, Susannah Walpole, Tim Keutzer

Category Research

Concept Oral Carbapenem Therapy

Concept Complicated Urinary Tract Infection

Concept Oral Carbapenem

Concept ADAPT-PO Trial

Concept Noninferiority Trial

Distinguished Non-Finalist

Presenter Organization Spero Therapeutics, Inc.

Presenting Author Angela Talley

Track Value in Hospital Medicine

Keywords

tebipenem pivoxil hydrobromide

TBP-PI-HBr

complicated urinary tract infection

acute pyelonephritis

ertapenem

phase 3 trial

non-inferior efficacy

oral carbapenem

resistant gram-negative pathogens

test-of-cure

Oral Carbapenem Therapy

Complicated Urinary Tract Infection

Oral Carbapenem

ADAPT-PO Trial

Noninferiority Trial