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7. Pooled analysis of single-dose oritavancin in the treatment of acute bacterial skin and skin-structure infections caused by Gram-positive pathogens, including a large patient subset with methicillin-resistant Staphylococcus aureus

Author

Corey, G. Ralph, Arhin, Francis F., Wikler, Matthew A., Sahm, Daniel F., Kreiswirth, Barry N., Mediavilla, José R., Good, Samantha, Fiset, Claude, Jiang, Hai, Moeck, Greg, Kabler, Heidi, Green, Sinikka, and O'Riordan, William

Published
2016
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8. In Vitro Activity of Cefepime-Taniborbactam and Comparators against Clinical Isolates of Gram-Negative Bacilli from 2018 to 2020: Results from the Global Evaluation of Antimicrobial Resistance via Surveillance (GEARS) Program

Author

Karlowsky, James A., primary, Hackel, Meredith A., additional, Wise, Mark G., additional, Six, David A., additional, Uehara, Tsuyoshi, additional, Daigle, Denis M., additional, Cusick, Susan M., additional, Pevear, Daniel C., additional, Moeck, Greg, additional, and Sahm, Daniel F., additional

Published
2023
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14. 133. ARGONAUT-III: Susceptibility of Carbapenem-resistant Klebsiellae to Cefepime-Taniborbactam

Author

Mack, Andrew R, primary, Bethel, Christopher, additional, Marshall, Steven, additional, Patel, Robin, additional, van Duin, David, additional, Fowler, Vance G, additional, Rhoads, Daniel D, additional, Jacobs, Michael, additional, van den Akker, Focco, additional, Six, David A, additional, Moeck, Greg, additional, Papp-Wallace, Krisztina M, additional, and Bonomo, Robert A, additional

Published
2021
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15. 1055. ARGONAUT-IV: Susceptibility of Carbapenem-resistant Klebsiellae to Ceftibuten/VNRX-5236

Author

Mack, Andrew R, primary, Bethel, Christopher, additional, Marshall, Steven, additional, Patel, Robin, additional, van Duin, David, additional, Fowler, Vance G, additional, Rhoads, Daniel D, additional, Jacobs, Michael, additional, van den Akker, Focco, additional, Six, David A, additional, Moeck, Greg, additional, Papp-Wallace, Krisztina M, additional, and Bonomo, Robert A, additional

Published
2021
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16. 1063. ARGONAUT-V: Susceptibility of Multidrug-Resistant (MDR) Pseudomonas aeruginosa to Cefepime-Taniborbactam

Author

Mack, Andrew R, primary, Bethel, Christopher, additional, Marshall, Steven, additional, Patel, Robin, additional, van Duin, David, additional, Fowler, Vance G, additional, Rhoads, Daniel D, additional, Jacobs, Michael, additional, van den Akker, Focco, additional, Six, David A, additional, Moeck, Greg, additional, Papp-Wallace, Krisztina M, additional, and Bonomo, Robert A, additional

Published
2021
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18. Discovery of VNRX-7145 (VNRX-5236 Etzadroxil): An Orally Bioavailable β-Lactamase Inhibitor for Enterobacterales Expressing Ambler Class A, C, and D Enzymes

Author

Trout, Robert E., primary, Zulli, Allison, additional, Mesaros, Eugen, additional, Jackson, Randy W., additional, Boyd, Steven, additional, Liu, Bin, additional, Hamrick, Jodie, additional, Daigle, Denis, additional, Chatwin, Cassandra L., additional, John, Kaitlyn, additional, McLaughlin, Lisa, additional, Cusick, Susan M., additional, Weiss, William J., additional, Pulse, Mark E., additional, Pevear, Daniel C., additional, Moeck, Greg, additional, Xerri, Luigi, additional, and Burns, Christopher J., additional

Published
2021
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22. A new class of small molecule RNA polymerase inhibitors with activity against Rifampicin-resistant Staphylococcus aureus

Author

Arhin, Francis, Bélanger, Odette, Ciblat, Stéphane, Dehbi, Mohammed, Delorme, Daniel, Dietrich, Evelyne, Dixit, Dilip, Lafontaine, Yanick, Lehoux, Dario, Liu, Jing, McKay, Geoffrey A., Moeck, Greg, Reddy, Ranga, Rose, Yannick, Srikumar, Ramakrishnan, Tanaka, Kelly S.E., Williams, Daniel M., Gros, Philippe, Pelletier, Jerry, Parr, Thomas R., Jr., and Far, Adel Rafai

Published
2006
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23. VNRX-5133 (Taniborbactam), a Broad-Spectrum Inhibitor of Serine- and Metallo-β-Lactamases, Restores Activity of Cefepime in Enterobacterales and Pseudomonas aeruginosa

Author

Hamrick, Jodie C., primary, Docquier, Jean-Denis, additional, Uehara, Tsuyoshi, additional, Myers, Cullen L., additional, Six, David A., additional, Chatwin, Cassandra L., additional, John, Kaitlyn J., additional, Vernacchio, Salvador F., additional, Cusick, Susan M., additional, Trout, Robert E. L., additional, Pozzi, Cecilia, additional, De Luca, Filomena, additional, Benvenuti, Manuela, additional, Mangani, Stefano, additional, Liu, Bin, additional, Jackson, Randy W., additional, Moeck, Greg, additional, Xerri, Luigi, additional, Burns, Christopher J., additional, Pevear, Daniel C., additional, and Daigle, Denis M., additional

Published
2020
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37. Single-Dose Oritavancin Versus 7–10 Days of Vancomycin in the Treatment of Gram-Positive Acute Bacterial Skin and Skin Structure Infections: The SOLO II Noninferiority Study

Author

Corey, G. Ralph, primary, Good, Samantha, additional, Jiang, Hai, additional, Moeck, Greg, additional, Wikler, Matthew, additional, Green, Sinikka, additional, Manos, Paul, additional, Keech, Richard, additional, Singh, Rajesh, additional, Heller, Barry, additional, Bubnova, Natalia, additional, and O'Riordan, William, additional

Published
2014
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41. Single-Dose Oritavancin Versus 7–10 Days of Vancomycin in the Treatment of Gram-Positive Acute Bacterial Skin and Skin Structure Infections: The SOLO II Noninferiority Study.

Author

Corey, G. Ralph, Good, Samantha, Jiang, Hai, Moeck, Greg, Wikler, Matthew, Green, Sinikka, Manos, Paul, Keech, Richard, Singh, Rajesh, Heller, Barry, Bubnova, Natalia, and O'Riordan, William

Subjects
GRAM-positive bacterial infections, METHICILLIN-resistant staphylococcus aureus treatment, VANCOMYCIN, TREATMENT effectiveness, PHARMACOKINETICS, BACTERIAL disease treatment
Abstract

A single 1200-mg dose of oritavancin was noninferior to 7–10 days of vancomycin for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by gram-positive pathogens. Oritavancin provides a single-dose alternative to multi-dose therapies for ABSSSI.Background. Oritavancin is a lipoglycopeptide antibiotic with rapid bactericidal activity against gram-positive bacteria. Its concentration-dependent activity and long half-life allow for single-dose treatment.Methods. In a randomized, double-blind trial, adults with acute bacterial skin and skin structure infections (ABSSSIs) received either a single intravenous 1200-mg dose of oritavancin or 7–10 days of twice-daily vancomycin. Three efficacy endpoints were tested for noninferiority: (1) primary composite endpoint at 48–72 hours (cessation of spreading or reduction in lesion size, absence of fever, and no rescue antibiotic); (2) investigator-assessed clinical cure 7–14 days after end of treatment; and (3) ≥20% reduction in lesion area at 48–72 hours.Results. A total of 503 and 502 patients comprised the modified intent-to-treat population for oritavancin and vancomycin, respectively. All 3 efficacy endpoints met the 10% noninferiority margin: the primary composite endpoint (80.1% vs 82.9%; 95% confidence interval [CI], −7.5 to 2.0), investigator-assessed clinical cure (82.7% vs 80.5%; 95% CI, −2.6 to 7.0), and proportion of patients attaining ≥20% reduction in lesion area (85.9% vs 85.3%; 95% CI, −3.7 to 5.0) for oritavancin vs vancomycin, respectively. Efficacy outcomes by pathogen, including methicillin-resistant Staphylococcus aureus and the frequency of adverse events, were similar between treatment groups.Conclusions. A single 1200-mg dose of oritavancin was noninferior to 7–10 days of vancomycin in treating ABSSSIs caused by gram-positive pathogens, and was well tolerated. Oritavancin provides a single-dose alternative to multidose therapies for the treatment of ABSSSIs.Clinical Trials Registration. NCT01252732. [ABSTRACT FROM PUBLISHER]

Published
2015
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42. Antimicrobial drug discovery through bacteriophage genomics

Author

Liu, Jing, primary, Dehbi, Mohammed, additional, Moeck, Greg, additional, Arhin, Francis, additional, Bauda, Pascale, additional, Bergeron, Dominique, additional, Callejo, Mario, additional, Ferretti, Vincent, additional, Ha, Nhuan, additional, Kwan, Tony, additional, McCarty, John, additional, Srikumar, Ramakrishnan, additional, Williams, Dan, additional, Wu, Jinzi J, additional, Gros, Philippe, additional, Pelletier, Jerry, additional, and DuBow, Michael, additional

Published
2004
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44. Comparative In VitroActivities of Oritavancin, Dalbavancin, and Vancomycin against Methicillin-Resistant Staphylococcus aureusIsolates in a Nondividing State

Author

Belley, Adam, Lalonde Seguin, David, Arhin, Francis, and Moeck, Greg

Abstract

ABSTRACTAntibacterial agents that kill nondividing bacteria may be of utility in treating persistent infections. Oritavancin and dalbavancin are bactericidal lipoglycopeptides that are approved for acute bacterial skin and skin structure infections in adults caused by susceptible Gram-positive pathogens. Using time-kill methodology, we demonstrate that oritavancin exerts bactericidal activity against methicillin-resistant Staphylococcus aureus(MRSA) isolates that are maintained in a nondividing state in vitro, whereas dalbavancin and the glycopeptide vancomycin do not.

Published
2016
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45. Use of In VitroVancomycin Testing Results To Predict Susceptibility to Oritavancin, a New Long-Acting Lipoglycopeptide

Author

Jones, Ronald N., Turnidge, John D., Moeck, Greg, Arhin, Francis F., and Mendes, Rodrigo E.

Abstract

ABSTRACTOritavancin is a recently approved lipoglycopeptide antimicrobial agent with activity against Gram-positive pathogens. Its extended serum elimination half-life and concentration-dependent killing enable single-dose treatment of acute bacterial skin and skin structure infections. At the time of regulatory approval, new agents, including oritavancin, are not offered in the most widely used susceptibility testing devices and therefore may require application of surrogate testing using a related antimicrobial to infer susceptibility. To evaluate vancomycin as a predictive susceptibility marker for oritavancin, 26,993 recent Gram-positive organisms from U.S. and European hospitals were tested using reference MIC methods. Organisms included Staphylococcus aureus, coagulase-negative staphylococci (CoNS), beta-hemolytic streptococci (BHS), viridans group streptococci (VGS), and enterococci (ENT). These five major pathogen groups were analyzed by comparing results with FDA-approved susceptible breakpoints for both drugs, as well as those suggested by epidemiological cutoff values and supported by pharmacokinetic/pharmacodynamic analyses. Vancomycin susceptibility was highly accurate (98.1 to 100.0%) as a surrogate for oritavancin susceptibility among the indicated pathogen species. Furthermore, direct MIC comparisons showed high oritavancin potencies, with vancomycin/oritavancin MIC90results of 1/0.06, 2/0.06, 0.5/0.12,1/0.06, and >16/0.06 μg/ml for S. aureus, CoNS, BHS, VGS, and ENT, respectively. In conclusion, vancomycin demonstrated acceptable accuracy as a surrogate marker for predicting oritavancin susceptibility when tested against the indicated pathogens. In contrast, 93.3% of vancomycin-nonsusceptible enterococci had oritavancin MIC values of ≤0.12 μg/ml, indicating a poor predictive value of vancomycin for oritavancin resistance against these organisms. Until commercial oritavancin susceptibility testing devices are readily available, isolates that when tested show vancomycin susceptibility can be inferred to be susceptible to oritavancin by using FDA-approved breakpoints.

Published
2015
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46. Antimicrobial drug discovery through bacteriophage genomics.

Author

Arhin, Francis, Bauda, Pascale, Bergeron, Dominique, Callejo, Mario, Ferretti, Vincent, Nhuan Ha, Vincent, Kwan, Tony, McCarty, John, Srikumar, Ramakrishnan, Williams, Dan, Jinzi J. Wu, Dan, Gros, Philippe, Pelletier, Jerry, DuBow, Michael, Jing Liu, Dehbi, Mohammed, and Moeck, Greg

Subjects
ANTI-infective agents, BACTERIOPHAGE genetics, ANTIBIOTICS, GENETICS of staphylococcus aureus infections, DNA replication, COMMUNICABLE diseases
Abstract

Over evolutionary time bacteriophages have developed unique proteins that arrest critical cellular processes to commit bacterial host metabolism to phage reproduction. Here, we apply this concept of phage-mediated bacterial growth inhibition to antibiotic discovery. We sequenced 26 Staphylococcus aureus phages and identified 31 novel polypeptide families that inhibited growth upon expression in S. aureus. The cellular targets for some of these polypeptides were identified and several were shown to be essential components of the host DNA replication and transcription machineries. The interaction between a prototypic pair, ORF104 of phage 77 and DnaI, the putative helicase loader of S. aureus, was then used to screen for small molecule inhibitors. Several compounds were subsequently found to inhibit both bacterial growth and DNA synthesis. Our results suggest that mimicking the growth-inhibitory effect of phage polypeptides by a chemical compound, coupled with the plethora of phages on earth, will yield new antibiotics to combat infectious diseases. [ABSTRACT FROM AUTHOR]

Published
2004
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47. Pharmacodynamics of a Simulated Single 1,200-Milligram Dose of Oritavancin in an In VitroPharmacokinetic/Pharmacodynamic Model of Methicillin-Resistant Staphylococcus aureusInfection

Author

Belley, Adam, Arhin, Francis F., Sarmiento, Ingrid, Deng, Hong, Rose, Warren, and Moeck, Greg

Abstract

ABSTRACTThe safety and efficacy of a single 1,200-mg dose of the lipoglycopeptide oritavancin are currently being investigated in two global phase 3 studies of acute bacterial skin and skin structure infections. In this study, an in vitropharmacokinetic/pharmacodynamic model was established to compare the free-drug pharmacodynamics associated with a single 1,200-mg dose of oritavancin to once-daily dosing with daptomycin at 6 mg/kg of body weight and twice-daily dosing with vancomycin at 1,000 mg against three methicillin-resistant Staphylococcus aureus(MRSA) strains over 72 h. The area under the bacterial-kill curve (AUBKC) was used to assess the antibacterial effect of each dosing regimen at 24 h (AUBKC0-24), 48 h (AUBKC0-48), and 72 h (AUBKC0-72). The rapid bactericidal activities of oritavancin and daptomycin contributed to lower AUBKC0-24s for the three MRSA strains than with vancomycin (P< 0.05, as determined by analysis of variance [ANOVA]). Oritavancin exposure also resulted in a lower AUBKC0-48and AUBKC0-72against one MRSA strain and a lower AUBKC0-48for another strain than did vancomycin exposure (P< 0.05). Furthermore, daptomycin exposure resulted in a lower AUBKC0-48and AUBKC0-72for one of the MRSA isolates than did vancomycin exposure (P< 0.05). Lower AUBKC0-24s for two of the MRSA strains (P< 0.05) were obtained with oritavancin exposure than with daptomycin. Thus, the antibacterial effect from the single-dose regimen of oritavancin is as effective as that from either once-daily dosing with daptomycin or twice-daily dosing with vancomycin against the MRSA isolates tested in an in vitropharmacokinetic/pharmacodynamic model over 72 h. These results provide further justification to assess the single 1,200-mg dose of oritavancin for treatment of acute bacterial skin and skin structure infections.

Published
2012
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48. VNRX-5133 (Taniborbactam), a Broad-Spectrum Inhibitor of Serine- and Metallo-β-Lactamases, Restores Activity of Cefepime in Enterobacteralesand Pseudomonas aeruginosa

Author

Hamrick, Jodie C., Docquier, Jean-Denis, Uehara, Tsuyoshi, Myers, Cullen L., Six, David A., Chatwin, Cassandra L., John, Kaitlyn J., Vernacchio, Salvador F., Cusick, Susan M., Trout, Robert E. L., Pozzi, Cecilia, De Luca, Filomena, Benvenuti, Manuela, Mangani, Stefano, Liu, Bin, Jackson, Randy W., Moeck, Greg, Xerri, Luigi, Burns, Christopher J., Pevear, Daniel C., and Daigle, Denis M.

Abstract

As shifts in the epidemiology of β-lactamase-mediated resistance continue, carbapenem-resistant Enterobacterales(CRE) and carbapenem-resistant Pseudomonas aeruginosa(CRPA) are the most urgent threats.

Published
2020
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49. Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies

Author

Corey, G. Ralph, Loutit, Jeffery, Moeck, Greg, Wikler, Matthew, Dudley, Michael N., and O'Riordan, William

Abstract

ABSTRACTOritavancin is a lipoglycopeptide with bactericidal activity against Gram-positive organisms. Its rapid concentration-dependent bactericidal activity and long elimination half-life allow single-dose treatment of acute bacterial skin and skin structure infections (ABSSSI). SOLO I and SOLO II were randomized, double-blind studies evaluating the efficacy and safety of a single 1,200-mg intravenous (i.v.) dose of oritavancin versus twice-daily i.v. vancomycin for 7 to 10 days in ABSSSI patients. Safety data from both studies were pooled for safety analysis. The database comprised pooled safety data for 976 oritavancin-treated patients and 983 vancomycin-treated patients. The incidences of adverse events, serious adverse events, and discontinuations due to adverse events were similar for oritavancin (55.3, 5.8, and 3.7%, respectively) and vancomycin (56.9, 5.9, and 4.2%, respectively). The median time to onset (3.8 days versus 3.1 days, respectively) and the duration (3.0 days for both groups) of adverse events were also similar between the two groups. The most frequently reported events were nausea, headache, and vomiting. Greater than 90% of all events were mild or moderate in severity. There were slightly more infections and infestations, abscesses or cellulitis, and hepatic and cardiac adverse events in the oritavancin group; however, more than 80% of these events were mild or moderate. Subgroup analyses did not identify clinically meaningful differences in the incidence of adverse events attributed to oritavancin. A single 1,200-mg dose of oritavancin was well tolerated and had a safety profile similar to that of twice-daily vancomycin. The long elimination half-life of oritavancin compared to that of vancomycin did not result in a clinically meaningful delay to the onset or prolongation of adverse events. (This study has been registered at ClinicalTrials.gov under registration no. NCT01252719 and NCT01252732.)

Published
2018
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50. Evaluation of Oritavancin Dosing Strategies against Vancomycin-Resistant Enterococcus faeciumIsolates with or without Reduced Susceptibility to Daptomycin in an In VitroPharmacokinetic/Pharmacodynamic Model

Author

Belley, Adam, Arhin, Francis F., and Moeck, Greg

Abstract

ABSTRACTThe clinical development of nonsusceptibility to the lipopeptide antibiotic daptomycin remains a serious concern during therapy for infections caused by vancomycin-resistant Enterococcus faecium(VREfm). The long-acting lipoglycopeptide oritavancin exhibits potent in vitroactivity against VREfm, although its safety and efficacy for treating clinical VREfm infections have not been established. In this study, novel dosing regimens of daptomycin and oritavancin were assessed against both VREfm and daptomycin-nonsusceptible VREfm isolates in an in vitropharmacokinetic/pharmacodynamic model.

Published
2017
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