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

por Dane, Aaron, Rex, John H, Newell, Paul, Stallard, Nigel
Publicado 2022

LB-3. Oral Tebipenem Pivoxil Hydrobromide is Non-inferior to IV Ertapenem in Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP) – Results from the Pivotal ADA...

por Muir, Lori A, Walpole, Susannah M, Warfel, Patricia A, Kwak, Hanna, Phelan, Anne-Marie, Moore, Gary E, Jain, Akash, Keutzer, Tim, Dane, Aaron, Dane, Aaron, Melnick, David, Talley, Angela K
Publicado 2020

LB-5. DAV132 Protects Intestinal Microbiota of Patients Treated with Quinolones, a European Phase II Randomized Controlled Trial (SHIELD)

por Ducher, Annie, Vehreschild, Maria J G T, Vehreschild, Maria J G T, Louie, Thomas J, Cornely, Oliver A, Féger, Céline, Dane, Aaron, Dane, Aaron, Varastet, Marina, de Gunzburg, Jean, Andremont, Antoine, Mentré, France
Publicado 2020

Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

por McDonnell, Anthony, Rex, John H., Goossens, Herman, Bonten, Marc, Fowler, Vance G., Dane, Aaron
Publicado 2016

Safety, Pharmacokinetics, and Food Effect of Tebipenem Pivoxil Hydrobromide after Single and Multiple Ascending Oral Doses in Healthy Adult Subjects

por Eckburg, Paul B., Jain, Akash, Walpole, Susannah, Moore, Grayson, Utley, Luke, Manyak, Erika, Dane, Aaron, Melnick, David
Publicado 2019

1288. Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial I...

por Talley, Angela, Thurston, Archie, Moore, Grayson, Satterfield, Myriah M, Manyak, Erika L, Kumar, Vipul, Stokes, Suzanne, Dane, Aaron, Melnick, David
Publicado 2020

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

por Talley, Angela K., Thurston, Archie, Moore, Grayson, Gupta, Vipul K., Satterfield, Myriah, Manyak, Erika, Stokes, Suzanne, Dane, Aaron, Melnick, David
Publicado 2021

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)

por McGovern, Paul C, Wagenlehner, Florian, Gasink, Leanne, Moeck, Greg, McLeroth, Patrick L, Beth, Mary, Dane, Aaron, Henkel, Tim
Publicado 2022

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 o...

por Maertens, Johan A, Verweij, Paul E, Lanuza, Evan F, Harvey, Emma L, Dane, Aaron, Zinzi, Daniela, Rex, John H, Chen, Sharon C
Publicado 2022

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 effi...

por Mangino, Julie E., Firstenberg, Michael S., Milewski, Rita K.C., Rhys-Williams, William, Lees, James P., Dane, Aaron, Love, William G., Gonzalez Moreno, Jesus
Publicado 2023

Progress in the Fight Against Multidrug-Resistant Bacteria 2005–2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance...

por Rex, John H, Talbot, George H, Goldberger, Mark J, Eisenstein, Barry I, Echols, Roger M, Tomayko, John F, Dudley, Michael N, Dane, Aaron
Publicado 2017

Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomiz...

por Kaye, Keith S, Rice, Louis B, Dane, Aaron L, Stus, Viktor, Sagan, Olexiy, Fedosiuk, Elena, Das, Anita F, Skarinsky, David, Eckburg, Paul B, Ellis-Grosse, Evelyn J
Publicado 2019

An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolo...

por Vehreschild, Maria J. G. T., Ducher, Annie, Louie, Thomas, Cornely, Oliver A., Feger, Celine, Dane, Aaron, Varastet, Marina, Vitry, Fabien, de Gunzburg, Jean, Andremont, Antoine, Mentré, France, Wilcox, Mark H.
Publicado 2022

Software for Dosage Individualization of Voriconazole: a Prospective Clinical Study

por Hope, William, Johnstone, Gary, Cicconi, Silvia, Felton, Timothy, Goodwin, Joanne, Whalley, Sarah, Santoyo-Castelazo, Anahi, Ramos-Martin, Virginia, Lestner, Jodi, Credidio, Leah, Dane, Aaron, Carr, Daniel F., Pirmohamed, Munir, Salim, Rahim, Neely, Michael
Publicado 2019

Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE’s STAT-Net

por de Kraker, Marlieke E A, Sommer, Harriet, de Velde, Femke, Gravestock, Isaac, Weiss, Emmanuel, McAleenan, Alexandra, Nikolakopoulos, Stavros, Amit, Ohad, Ashton, Teri, Beyersmann, Jan, Held, Leonhard, Lovering, Andrew M, MacGowan, Alasdair P, Mouton, Johan W, Timsit, Jean-François, Wilson, David, Wolkewitz, Martin, Bettiol, Esther, Dane, Aaron, Harbarth, Stephan
Publicado 2018