Publications by authors named "Steven Gelone"

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Anti-inflammatory activity of lefamulin versus azithromycin and dexamethasone in vivo and in vitro in a lipopolysaccharide-induced lung neutrophilia mouse model.
Michael Hafner, Susanne Paukner, Wolfgang W Wicha, Boška Hrvačić, Matea Cedilak, Steven P Gelone

PLoS One· July 2024

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In Vivo Immune-Modulatory Activity of Lefamulin in an Influenza Virus A (H1N1) Infection Model in Mice.
Susanne Paukner, Sandra Kimber, Charlotte Cumper, Tina Rea-Davies, Lorena Sueiro Ballesteros, Steven P Gelone

Int J Mol Sci· May 2024

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Physiologically-based pharmacokinetic modeling of the drug-drug interaction between ivacaftor and lefamulin in cystic fibrosis patients.
Magali Amiel, Alice Ke, Steven P Gelone, Hannah M Jones, Wolfgang Wicha

CPT Pharmacometrics Syst Pharmacol· April 2024

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7-Year (2015-21) longitudinal surveillance of lefamulin in vitro activity against bacterial pathogens collected worldwide from patients with respiratory tract infections including pneumonia and characterization of resistance mechanisms.
Susanne Paukner, Rodrigo E Mendes, S J Ryan Arends, Gisela Gassner, Steven P Gelone

J Antimicrob Chemother· February 2024

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Safety and Pharmacokinetics Following Oral or Intravenous Lefamulin in Adults With Cystic Fibrosis.
Gregory S Sawicki, Wolfgang W Wicha, Tara S Hiley, Nicole C Close, Steven P Gelone

Clin Ther· February 2024

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Improving Traditional Registrational Trial End Points: Development and Application of a Desirability of Outcome Ranking End Point for Complicated Urinary Tract Infection Clinical Trials.
Jessica Howard-Anderson, Toshimitsu Hamasaki, Weixiao Dai, Deborah Collyar, Daniel Rubin, Steven P Gelone

Clin Infect Dis· February 2023

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Pharmacodynamic evaluation of lefamulin in the treatment of gonorrhea using a hollow fiber infection model simulating infections.
Susanne Jacobsson, Daniel Golparian, Joakim Oxelbark, Wolfgang W Wicha, Renata Maria Augusto da Costa, Steven P Gelone

Front Pharmacol· November 2022

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Tissue Distribution of [C]-Lefamulin into the Urogenital Tract in Rats.
Wolfgang W Wicha, Claire Henson, Kathryn Webbley, Steven P Gelone

Antimicrob Agents Chemother· August 2022

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Pooled microbiological findings and efficacy outcomes by pathogen in adults with community-acquired bacterial pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 phase 3 trials of lefamulin versus moxifloxacin.
Susanne Paukner, Lisa Goldberg, Elizabeth Alexander, Anita F Das, Stefanie Heinrich, Steven P Gelone

J Glob Antimicrob Resist· June 2022

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A plain language summary of how lefamulin alone can be used to treat pneumonia caught outside of the hospital due to common bacterial causes, including drug-resistant bacteria.
Susanne Paukner, Gregory J Moran, Christian Sandrock, Thomas M File, Jorge E Vidal, Steven P Gelone

Future Microbiol· April 2022

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A Multicenter Evaluation of the US Prevalence and Regional Variation in Macrolide-Resistant in Ambulatory and Hospitalized Adult Patients in the United States.
Vikas Gupta, Kalvin C Yu, Jennifer Schranz, Steven P Gelone

Open Forum Infect Dis· July 2021

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Pharmacokinetics and safety of lefamulin after single intravenous dose administration in subjects with impaired renal function and those requiring hemodialysis.
Wolfgang W Wicha, Thomas C Marbury, James A Dowell, Jared L Crandon, Cathie Leister, Steven P Gelone

Pharmacotherapy· May 2021

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Pharmacokinetics and safety of lefamulin after single intravenous dose administration in subjects with impaired-hepatic function.
Wolfgang W Wicha, Thomas C Marbury, James A Dowell, Jared L Crandon, Cathie Leister, Steven P Gelone

Pharmacotherapy· May 2021

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Reply to Tang and Lai.
Thomas M File, Steven P Gelone, Jennifer Schranz, Elizabeth Alexander

Clin Infect Dis· September 2020

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Erratum to: Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.
Thomas M File, Lisa Goldberg, Anita Das, Carolyn Sweeney, John Saviski, Steven P Gelone

Clin Infect Dis· May 2020

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Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.
Thomas M File, Lisa Goldberg, Anita Das, Carolyn Sweeney, John Saviski, Steven P Gelone

Clin Infect Dis· November 2019

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Hospital-level high-risk antibiotic use in relation to hospital-associated infections: Retrospective analysis of 2016-2017 data from US hospitals.
Ying P Tabak, Arjun Srinivasan, Kalvin C Yu, Stephen G Kurtz, Vikas Gupta, Steven Gelone

Infect Control Hosp Epidemiol· November 2019

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Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial.
Elizabeth Alexander, Lisa Goldberg, Anita F Das, Gregory J Moran, Christian Sandrock, Steven P Gelone

JAMA· November 2019

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Antibacterial Activity of Lefamulin against Pathogens Most Commonly Causing Community-Acquired Bacterial Pneumonia: SENTRY Antimicrobial Surveillance Program (2015-2016).
Susanne Paukner, Steven P Gelone, S J Ryan Arends, Robert K Flamm, Helio S Sader

Antimicrob Agents Chemother· April 2019

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Low Prevalence of Gram-Positive Isolates Showing Elevated Lefamulin MIC Results during the SENTRY Surveillance Program for 2015-2016 and Characterization of Resistance Mechanisms.
Rodrigo E Mendes, Susanne Paukner, Timothy B Doyle, Steven P Gelone, Robert K Flamm

Antimicrob Agents Chemother· April 2019

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Pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing.
Wolfgang W Wicha, William T Prince, Claudia Lell, Werner Heilmayer, Steven P Gelone

J Antimicrob Chemother· April 2019

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Pharmacokinetic/pharmacodynamic target attainment analyses to support intravenous and oral lefamulin dose selection for the treatment of patients with community-acquired bacterial pneumonia.
Sujata M Bhavnani, Li Zhang, Jeffrey P Hammel, Christopher M Rubino, Justin C Bader, Steven P Gelone

J Antimicrob Chemother· April 2019

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Effects of a plasma-derived C1 esterase inhibitor on hemostatic activation, clot formation, and thrombin generation.
Jerrold H Levy, Fania Szlam, Steven Gelone

Blood Coagul Fibrinolysis· December 2014

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Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials.
Stuart Johnson, Thomas J Louie, Dale N Gerding, Oliver A Cornely, Scott Chasan-Taber, Steven P Gelone

Clin Infect Dis· August 2014

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Clostridium difficile in the long-term care setting.
Alex T Makris, Steven Gelone

J Am Med Dir Assoc· June 2007

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