Accès ouvert
2026
article
OpenAlex
Jennifer Chua, Annette Gray, Steven I. Aronin, Sailaja Puttagunta et autres
ABSTRACT Bacillus anthracis is a gram-positive, spore-forming bacterium and the etiological agent of anthrax. As a Tier 1 Select Agent, the pathogen can be isolated from the natural environment, and the endospore is a significant biological threat that can be produced in …
us, fr
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Accès ouvert
2026
article
OpenAlex
Steven I. Aronin, Sailaja Puttagunta, Jayanti Gupta, Manali Pendse et autres
Abstract Background Outpatients presenting with signs and symptoms of uncomplicated urinary tract infection (uUTI) are typically managed with an empiric course of antibiotic therapy. Treatment failure resulting in the need for repeated courses of antibiotics may occur in patients with certain baseline …
us
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Accès ouvert
2026
article
OpenAlex
Steven I. Aronin, Michael D. Huband, H. D. Becker, Kelley A. Fedler et autres
Abstract Background Sulopenem is a thiopenem antibacterial with an oral and parenteral formulation. Sulopenem etzadroxil/probenecid, the oral formulation, was recently approved by the US FDA for the treatment of women with uncomplicated urinary tract infection. This study evaluated the in vitro activity …
us
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2025
article
OpenAlex
Sailaja Puttagunta, Steven I. Aronin, Jayanti Gupta, Anita Das et autres
BACKGROUND: Existing antibiotics for uncomplicated urinary tract infections are becoming less reliably effective owing to increasing antimicrobial resistance. Our objective was to evaluate the safety and efficacy of sulopenem/probenecid for uncomplicated urinary tract infections. METHODS: species). RESULTS: A total of 2222 patients …
us
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Accès ouvert
2025
article
OpenAlex
Steven I. Aronin, Michael D. Huband, H. D. Becker, Kelley A. Fedler et autres
Objectives Sulopenem is a thiopenem antibacterial with an oral and parenteral formulation. Sulopenem etzadroxil/probenecid, the oral formulation, was recently approved by the US FDA for the treatment of women with uncomplicated urinary tract infection. This study evaluated the in vitro activity of …
us
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Accès ouvert
2025
article
OpenAlex
Joshua Maher, Michael D. Huband, Jill Lindley, Paul R. Rhomberg et autres
ABSTRACT Sulopenem is an oral and intravenous penem antibiotic in clinical development for treatment of urinary tract and intra-abdominal infections caused by multidrug-resistant pathogens. This study evaluated in vitro antimicrobial activity of sulopenem by post-antibiotic effect (PAE), sub-inhibitory minimal inhibitory concentration PAE …
us
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Accès ouvert
2025
article
OpenAlex
Sailaja Puttagunta, Steven I. Aronin, Stephanie Halasohoris, Ashley L. Babyak et autres
Abstract Background Sulopenem (SUL) is a penem β-lactam antibiotic in development for the treatment of resistant bacterial infections. It is available as intravenous and oral prodrug formulations, and its activity aligns with the most urgent drug-resistant antimicrobial threats defined by the CDC. …
us
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Accès ouvert
2025
article
OpenAlex
Sailaja Puttagunta, Steven I. Aronin, Jayanti Gupta, Anita Das et autres
Abstract Background Existing oral antibiotics for treatment of uUTI are not reliably effective due to rising antimicrobial resistant uropathogens. Sulopenem is a broad-spectrum IV/oral penem being developed for treatment of multidrug resistant infections. We conducted a pivotal Phase 3 randomized, double-blind, double-dummy, …
us
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Accès ouvert
2025
article
OpenAlex
Steven I. Aronin, Michael W. Dunne, Sailaja Puttagunta
Abstract Background Per FDA Guidance, the primary efficacy endpoint for trials evaluating antimicrobials for treatment of UTI is a combined clinical/microbiologic response. Overall success requires both resolution of UTI symptoms and demonstration that the causative uropathogen is reduced to < 103 CFU/mL …
us
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Accès ouvert
2024
article
OpenAlex
Michael W. Dunne, Steven I. Aronin, Anita Das, Karthik Akinapelli et autres
OBJECTIVE: To demonstrate the non-inferiority of intravenous (IV) sulopenem to IV ertapenem, each followed by an oral regimen, in adults with complicated intra-abdominal infections (cIAI). METHODS: Hospitalized adults with cIAI were randomly assigned to 5 days of IV sulopenem followed by oral …
us
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Accès ouvert
2023
article
OpenAlex
Brian VanScoy, S. Jones, Haley Conde, Catherine E. Vincent et autres
Abstract Background Sulopenem etzadroxil, the oral (PO) prodrug of the active moiety sulopenem is a thiopenem with activity against drug-resistant pathogens known to cause uncomplicated urinary tract infection (uUTI). Oral sulopenem is a bilayer tablet composed of sulopenem etzadroxil and probenecid, an …
us
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Accès ouvert
2023
article
OpenAlex
Brian VanScoy, Haley Conde, Catherine E. Vincent, Sujata M. Bhavnani et autres
Abstract Background Sulopenem etzadroxil, the oral (PO) prodrug of the active moiety sulopenem, is a thiopenem in development for the treatment of uncomplicated urinary tract infection (uUTI). Oral sulopenem is a bilayer tablet composed of sulopenem etzadroxil and probenecid, an organic anion …
us
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