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Exeporfinium chloride (XF-73) nasal gel dosed over 24 hours prior to surgery significantly reduced Staphylococcus aureus nasal carriage in cardiac surgery patients: Safety and efficacy results from a randomized placebo-controlled phase 2 study

Autor: Julie E. Mangino, Michael S. Firstenberg, Rita K.C. Milewski, William Rhys-Williams, James P. Lees, Aaron Dane, William G. Love, Jesus Gonzalez Moreno

Publikováno v: Infection Control & Hospital Epidemiology. :1-3

We studied 83 cardiac-surgery patients with nasal S. aureus carriage who received 4 intranasal administrations of XF-73 nasal gel or placebo S. aureus nasal carriage reduction of 2.5 log10 with XF-73 compared to 0.4 log10 CFU/mL for those who receive

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0c51a390d1d010f2a4519306c2c7b526
https://doi.org/10.1017/ice.2023.17

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Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection

Autor: Paul B, Eckburg, Lori, Muir, Ian A, Critchley, Susannah, Walpole, Hanna, Kwak, Anne-Marie, Phelan, Gary, Moore, Akash, Jain, Tim, Keutzer, Aaron, Dane, David, Melnick, Angela K, Talley

Publikováno v: New England Journal of Medicine. 386:1327-1338

There is a need for oral antibiotic agents that are effective against multidrug-resistant gram-negative uropathogens. Tebipenem pivoxil hydrobromide is an orally bioavailable carbapenem with activity against uropathogenic Enterobacterales, including

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cd6c7adb993556a77d6acd87c8cd38ec
https://doi.org/10.1056/nejmoa2105462

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

Autor: Ian A Critchley, Paul B Eckburg, Lori A Muir, Aaron Dane, Gary E Moore, David Melnick, Angela K Talley

Publikováno v: Open Forum Infectious Diseases. 9

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 organis

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::2436cbf52f1fcce68705b1dea77a14ca
https://doi.org/10.1093/ofid/ofac492.300

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870. Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: Comparison of interim results from a Phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, Study 32)

Autor: Johan A Maertens, Paul E Verweij, Evan F Lanuza, Emma L Harvey, Aaron Dane, Daniela Zinzi, John H Rex, Sharon C Chen

Publikováno v: Open Forum Infectious Diseases. 9

Background Olorofim is a novel antifungal agent active against Aspergillus spp (including azole-resistant strains), rare, resistant moulds (e.g., Lomentospora prolificans) and dimorphic moulds. Serial images of Lomentospora prolificans infection foll

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::537f1e62e057fc0eebecc8fb28470a8c
https://doi.org/10.1093/ofid/ofac492.063

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731. CERTAIN-1: A Phase 3 Study of Cefepime-Taniborbactam Efficacy and Safety in the Treatment of Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP)

Autor: Paul C McGovern, Florian Wagenlehner, Leanne Gasink, Greg Moeck, Patrick L McLeroth, Mary Beth, Aaron Dane, Tim Henkel

Publikováno v: Open Forum Infectious Diseases. 9

Background Carbapenem-resistant Enterobacterales and multidrug resistant Pseudomonas aeruginosa are global antimicrobial resistance threats. Cefepime-taniborbactam (FTB) is an investigational β-lactam/ β-lactamase inhibitor combination that is acti

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::723ca35e57bb2a4899a5ba3baf454c7a
https://doi.org/10.1093/ofid/ofac492.022

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754. Olorofim for treatment of invasive fungal infections (IFI) due to moulds in patients with limited or no treatment options: Interim results from a Phase 2b open-label study (NCT03583164, Study 32)

Autor: Johan A Maertens, George R Thompson, Andrej Spec, Sarah P Hammond, Bart Rijnders, P Lewis White, Oliver A Cornely, Lesley Fitton, Aaron Dane, John H Rex, Sharon C Chen

Publikováno v: Open Forum Infectious Diseases. 9

Background Olorofim, the first orotomide antifungal, selectively inhibits fungal dihydroorotate dehydrogenase (DHODH), a key enzyme in fungal pyrimidine biosynthesis. Olorofim is active against Aspergillus (including azole-resistant and cryptic speci

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::d450d5b501106ef3aad5be42c9d20873
https://doi.org/10.1093/ofid/ofac492.039

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The Value of the Information That Can Be Generated: Optimizing Study Design to Enable the Study of Treatments Addressing an Unmet Need for Rare Pathogens

Autor: Aaron Dane, John H Rex, Paul Newell, Nigel Stallard

Publikováno v: Open forum infectious diseases. 9(7)

In traditional phase 3 trials confirming safety and efficacy of new treatments relative to a comparator, a 1-sided type I error rate of 2.5% is traditionally used and typically leads to minimum sizes of 300–600 subjects per study. However, for rare

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a9d71451a3cceedee0f87d21765b536
https://pubmed.ncbi.nlm.nih.gov/35854983

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First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of SPR720, a Novel Oral Bacterial DNA Gyrase (GyrB) Inhibitor for Mycobacterial Infections

Autor: Suzanne Stokes, Grayson Moore, Erika Manyak, Myriah M Satterfield, Vipul K Gupta, Aaron Dane, Archie Thurston, David Melnick, Angela K Talley

Publikováno v: Antimicrobial Agents and Chemotherapy

SPR720 (phosphate prodrug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor in development for nontuberculous mycobacterial pulmonary disease (NTM-PD) and pulmonary tuberculosis. SPR719 has demonstrated activity against c

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::620bf01ca3805a97c7e63dcc57403f9f
https://pubmed.ncbi.nlm.nih.gov/34491803

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