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Clinical Stability Indicators Between Ertapenem an ...
Clinical Stability Indicators Between Ertapenem and Tebipenem Pivoxil, an Oral Carbapenem, in Hospitalized Adults With Complicated Urinary Tract Infection
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This poster reports a subgroup analysis from the phase 3 ADAPT-PO trial, which compared oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) with intravenous ertapenem in hospitalized adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP). The study addressed an important stewardship issue: many patients with cUTI/AP, including those with multidrug-resistant gram-negative infections such as ESBL-producing and fluoroquinolone-resistant organisms, are hospitalized for IV therapy because oral options are limited.<br /><br />Patients were randomized 1:1 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). The analysis focused on time-to-event markers of clinical stability in the microbiologically intention-to-treat population, including overall patients and subgroups with bacteremia, systemic inflammatory response syndrome (SIRS), or ESBL-phenotype pathogens.<br /><br />Results showed similar early clinical recovery in both treatment groups. The mean time to improvement or resolution of baseline signs and symptoms was about 4 days in both groups, with a median of 3 days. The mean time to defervescence was 2.2 days in both groups, with a median of 2 days. Subgroup findings were also comparable: patients with bacteremia or SIRS had similar times to improvement and fever resolution across treatments, and outcomes in ESBL-infected patients were likewise close between oral tebipenem and IV ertapenem.<br /><br />Overall, the analysis suggests that markers of clinical stability occur early and are similar with oral TBP-PI-HBr and IV ertapenem. If approved, tebipenem pivoxil hydrobromide could provide a practical oral switch option for hospitalized patients with cUTI/AP, potentially enabling earlier discharge, reducing IV catheter-related complications, and improving antimicrobial stewardship.
Asset Subtitle
Angela Talley
Meta Tag
Author List
Aaron Dane, Angela Talley, David Melnick, Gary Moore, Lori Muir, Mauricio Rodriguez Jr., Michael Nowak, Nevidita Bhatt, Paul Eckburg
Category
Research
Concept
Oral Carbapenem Therapy
Concept
Complicated Urinary Tract Infection
Concept
Acute Pyelonephritis
Concept
ADAPT-PO Trial
Concept
Ertapenem
Distinguished
Non-Finalist
Presenter Organization
Spero Therapeutics, Inc.
Presenting Author
Angela Talley
Track
Transitions of Care
Keywords
tebipenem pivoxil hydrobromide
ertapenem
complicated urinary tract infection
acute pyelonephritis
phase 3 ADAPT-PO
clinical stability
oral switch therapy
multidrug-resistant gram-negative
ESBL-producing organisms
antimicrobial stewardship
Oral Carbapenem Therapy
Complicated Urinary Tract Infection
Acute Pyelonephritis
ADAPT-PO Trial
Ertapenem
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