Search Results - "Talbot, George H."

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 by File, Thomas M, Goldberg, Lisa, Das, Anita, Sweeney, Carolyn, Saviski, John, Gelone, Steven P, Seltzer, Elyse, Paukner, Susanne, Wicha, Wolfgang W, Talbot, George H, Gasink, Leanne B

“…Monotherapy with lefamulin, a novel, pleuromutilin antibiotic with intravenous and oral formulation options, was noninferior to moxifloxacin for efficacy and…”
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Bad Bugs, No Drugs: No ESKAPE! An Update from the Infectious Diseases Society of America by Boucher, Helen W., Talbot, George H., Bradley, John S., Edwards, John E., Gilbert, David, Rice, Louis B., Scheld, Michael, Spellberg, Brad, Bartlett, John

“…The Infectious Diseases Society of America (IDSA) continues to view with concern the lean pipeline for novel therapeutics to treat drug-resistant infections,…”
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Integrated Analysis of CANVAS 1 and 2: Phase 3, Multicenter, Randomized, Double-Blind Studies to Evaluate the Safety and Efficacy of Ceftaroline versus Vancomycin plus Aztreonam in Complicated Skin and Skin-Structure Infection by Corey, G. Ralph, Wilcox, Mark, Talbot, George H., David Friedland, H., Baculik, Tanya, Witherell, Gary W., Critchley, Ian, Das, Anita F., Thye, Dirk

“…Background. Methicillin-resistant Staphylococcus aureus (MRSA) is a common cause of complicated skin and skin-structure infection (cSSSI). Increasing…”
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Integrated Analysis of FOCUS 1 and FOCUS 2: Randomized, Doubled-Blinded, Multicenter Phase 3 Trials of the Efficacy and Safety of Ceftaroline Fosamil versus Ceftriaxone in Patients with Community-Acquired Pneumonia by File, Thomas M., Low, Donald E., Eckburg, Paul B., Talbot, George H., Friedland, H. David, Lee, Jon, Llorens, Lily, Critchley, Ian, Thye, Dirk

“…Background. Ceftaroline, the active form of ceftaroline fosamil, is a broad-spectrum cephalosporin with bactericidal activity against pathogens causing…”
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In Vitro Profiling of Ceftaroline against a Collection of Recent Bacterial Clinical Isolates from across the United States by Ge, Yigong, Biek, Donald, Talbot, George H, Sahm, Daniel F

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Phase 2 Study of Ceftaroline versus Standard Therapy in Treatment of Complicated Skin and Skin Structure Infections by Talbot, George H, Thye, Dirk, Das, Anita, Ge, Yigong

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The Antibiotic Development Pipeline for Multidrug‐Resistant Gram‐Negative Bacilli: Current and Future Landscapes by Talbot, George H.

“…Development of antibiotics to treat infections caused by multidrug‐resistant gram‐negative bacilli has lagged significantly behind development of antibiotics…”
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Pharmacokinetics and Safety of CXA-101, a New Antipseudomonal Cephalosporin, in Healthy Adult Male and Female Subjects Receiving Single- and Multiple-Dose Intravenous Infusions by YIGONG GE, WHITEHOUSE, M. J, FRIEDLAND, Ian, TALBOT, George H

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Considerations in Undertaking a Clinical Development Program for Hospital-Acquired Bacterial Pneumonia and/or Ventilator-Associated Bacterial Pneumonia by Talbot, George H.

“…Achieving marketing authorization for an antimicrobial for the treatment of hospital-acquired bacterial pneumonia (HABP) and/or ventilator-associated bacterial…”
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Clostridium difficile Infection-Daily Symptoms (CDI-DaySyms™) questionnaire: psychometric characteristics and responder thresholds by Talbot, George H, Kleinman, Leah, Davies, Evan, Hunsche, Elke, Revicki, Dennis, Roberts, Laurie, Rosenberg, Daniel, Nord, Carl Erik

“…The purpose of the current study was to determine the final content validation, psychometric characteristics, clinically meaningful improvement, and responder…”
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Understanding Early and Late Endpoints in Registrational Trials of Community-acquired Bacterial Pneumonia by Talbot, George H

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Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia by Talbot, George H, Das, Anita, Cush, Stephanie, Dane, Aaron, Wible, Michele, Echols, Roger, Torres, Antoni, Cammarata, Sue, Rex, John H, Powers, John H, Fleming, Thomas, Loutit, Jeffrey, Hoffmann, Steve

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Widening the Overton Window—While Avoiding Defenestration by Talbot, George H

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Bad Bugs Need Drugs: An Update on the Development Pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America by Talbot, George H., Bradley, John, Edwards, John E., Gilbert, David, Scheld, Michael, Bartlett, John G.

“…The Antimicrobial Availability Task Force (AATF) of the Infectious Diseases Society of America (IDSA) has viewed with concern the decreasing investment by…”
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Antimicrobial Agents for Complicated Skin and Skin-Structure Infections: Justification of Noninferiority Margins in the Absence of Placebo-Controlled Trials by Spellberg, Brad, Talbot, George H., Boucher, Helen W., Bradley, John S., Gilbert, David, Scheld, W. Michael, Edwards, John, Bartlett, John G.

“…Background. The United States Food and Drug Administration requires clinical trial noninferiority margins to preserve a fraction (eg, 50%) of the established…”
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Efficacy as an Important Facet of “Safety” in Clinical Trials: How Can We Do Our Best for Our Patients? by TALBOT, George H

“…Ensuring optimal efficacy is an important facet of patient safety during the conduct of a clinical trial, if, by “safety,” we mean the anticipation,…”
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Prospective Study of the Wilson Severity-of-Illness Scoring System for Complicated Skin and Skin Structure Infections by TALBOT, George H, O'NEAL, Tanya, DAS, Anita F, T, Dirk

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Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection by Boucher, Helen W, Wilcox, Mark, Talbot, George H, Puttagunta, Sailaja, Das, Anita F, Dunne, Michael W

“…Treatment of acute bacterial skin infection is becoming more complicated as antimicrobial resistance increases. In this trial of dalbavancin, a…”
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The Early Clinical Response Endpoint: Great Timing by the Food and Drug Administration? by Talbot, George H

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10 × '20 Progress—Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America by Boucher, Helen W., Talbot, George H., Benjamin, Daniel K., Bradley, John, Guidos, Robert J., Jones, Ronald N., Murray, Barbara E., Bonomo, Robert A., Gilbert, David

“…Infections caused by antibiotic-resistant bacteria, especially the "ESKAPE" pathogens, continue to increase in frequency and cause significant morbidity and…”
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