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Pharmacokinetics/Pharmacodynamics of Vaborbactam, a Novel Beta-Lactamase Inhibitor, in Combination with Meropenem.

Griffith DC, Sabet M, Tarazi Z, Lomovskaya O, Dudley MN.

Antimicrob Agents Chemother. 2018 Dec 21;63(1). pii: e01659-18. doi: 10.1128/AAC.01659-18. Print 2019 Jan.


Pharmacodynamics of Minocycline against Acinetobacter baumannii in a Rat Pneumonia Model.

Tarazi Z, Sabet M, Dudley MN, Griffith DC.

Antimicrob Agents Chemother. 2019 Jan 29;63(2). pii: e01671-18. doi: 10.1128/AAC.01671-18. Print 2019 Feb.


Effect and Safety of Meropenem-Vaborbactam versus Best-Available Therapy in Patients with Carbapenem-Resistant Enterobacteriaceae Infections: The TANGO II Randomized Clinical Trial.

Wunderink RG, Giamarellos-Bourboulis EJ, Rahav G, Mathers AJ, Bassetti M, Vazquez J, Cornely OA, Solomkin J, Bhowmick T, Bishara J, Daikos GL, Felton T, Furst MJL, Kwak EJ, Menichetti F, Oren I, Alexander EL, Griffith D, Lomovskaya O, Loutit J, Zhang S, Dudley MN, Kaye KS.

Infect Dis Ther. 2018 Dec;7(4):439-455. doi: 10.1007/s40121-018-0214-1. Epub 2018 Oct 1.


Absence of TetB identifies minocycline-susceptible isolates of Acinetobacter baumannii.

Lomovskaya O, Sun D, Rubio-Aparicio D, Nelson KJ, Thamlikitkul V, Dudley MN, Redell MA.

Int J Antimicrob Agents. 2018 Sep;52(3):404-406. doi: 10.1016/j.ijantimicag.2018.04.006. Epub 2018 Apr 14.


Effect of Meropenem-Vaborbactam vs Piperacillin-Tazobactam on Clinical Cure or Improvement and Microbial Eradication in Complicated Urinary Tract Infection: The TANGO I Randomized Clinical Trial.

Kaye KS, Bhowmick T, Metallidis S, Bleasdale SC, Sagan OS, Stus V, Vazquez J, Zaitsev V, Bidair M, Chorvat E, Dragoescu PO, Fedosiuk E, Horcajada JP, Murta C, Sarychev Y, Stoev V, Morgan E, Fusaro K, Griffith D, Lomovskaya O, Alexander EL, Loutit J, Dudley MN, Giamarellos-Bourboulis EJ.

JAMA. 2018 Feb 27;319(8):788-799. doi: 10.1001/jama.2018.0438.


Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Vaborbactam and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.

Rubino CM, Bhavnani SM, Loutit JS, Morgan EE, White D, Dudley MN, Griffith DC.

Antimicrob Agents Chemother. 2018 Mar 27;62(4). pii: e02228-17. doi: 10.1128/AAC.02228-17. Print 2018 Apr.


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.

Corey GR, Loutit J, Moeck G, Wikler M, Dudley MN, O'Riordan W; SOLO I and SOLO II investigators.

Antimicrob Agents Chemother. 2018 Mar 27;62(4). pii: e01919-17. doi: 10.1128/AAC.01919-17. Print 2018 Apr.


Single-Dose Pharmacokinetics and Safety of Meropenem-Vaborbactam in Subjects with Chronic Renal Impairment.

Rubino CM, Bhavnani SM, Loutit JS, Lohse B, Dudley MN, Griffith DC.

Antimicrob Agents Chemother. 2018 Feb 23;62(3). pii: e02103-17. doi: 10.1128/AAC.02103-17. Print 2018 Mar.


Activity of Simulated Human Dosage Regimens of Meropenem and Vaborbactam against Carbapenem-Resistant Enterobacteriaceae in an In Vitro Hollow-Fiber Model.

Sabet M, Tarazi Z, Rubio-Aparicio D, Nolan TG, Parkinson J, Lomovskaya O, Dudley MN, Griffith DC.

Antimicrob Agents Chemother. 2018 Jan 25;62(2). pii: e01969-17. doi: 10.1128/AAC.01969-17. Print 2018 Feb.


Use of Monte Carlo simulation and considerations for PK-PD targets to support antibacterial dose selection.

Trang M, Dudley MN, Bhavnani SM.

Curr Opin Pharmacol. 2017 Oct;36:107-113. doi: 10.1016/j.coph.2017.09.009. Epub 2017 Nov 10. Review.


Activity of Meropenem-Vaborbactam in Mouse Models of Infection Due to KPC-Producing Carbapenem-Resistant Enterobacteriaceae.

Sabet M, Tarazi Z, Nolan T, Parkinson J, Rubio-Aparicio D, Lomovskaya O, Dudley MN, Griffith DC.

Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01446-17. doi: 10.1128/AAC.01446-17. Print 2018 Jan.


β-Lactamase inhibitors: what you really need to know.

Ambrose PG, Lomovskaya O, Griffith DC, Dudley MN, VanScoy B.

Curr Opin Pharmacol. 2017 Oct;36:86-93. doi: 10.1016/j.coph.2017.09.001. Epub 2017 Oct 27. Review.


In Vitro Activity of Meropenem-Vaborbactam against Clinical Isolates of KPC-Positive Enterobacteriaceae.

Hackel MA, Lomovskaya O, Dudley MN, Karlowsky JA, Sahm DF.

Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01904-17. doi: 10.1128/AAC.01904-17. Print 2018 Jan.


A Retrospective Cohort Analysis Shows that Coadministration of Minocycline with Colistin in Critically Ill Patients Is Associated with Reduced Frequency of Acute Renal Failure.

Lodise TP, Fan W, Griffith DC, Dudley MN, Sulham KA.

Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01165-17. doi: 10.1128/AAC.01165-17. Print 2018 Jan.


Meropenem-Vaborbactam Resistance Selection, Resistance Prevention, and Molecular Mechanisms in Mutants of KPC-Producing Klebsiella pneumoniae.

Sun D, Rubio-Aparicio D, Nelson K, Dudley MN, Lomovskaya O.

Antimicrob Agents Chemother. 2017 Nov 22;61(12). pii: e01694-17. doi: 10.1128/AAC.01694-17. Print 2017 Dec.


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

Rex JH, Talbot GH, Goldberger MJ, Eisenstein BI, Echols RM, Tomayko JF, Dudley MN, Dane A.

Clin Infect Dis. 2017 Jul 1;65(1):141-146. doi: 10.1093/cid/cix246. Review.


Vaborbactam: Spectrum of Beta-Lactamase Inhibition and Impact of Resistance Mechanisms on Activity in Enterobacteriaceae.

Lomovskaya O, Sun D, Rubio-Aparicio D, Nelson K, Tsivkovski R, Griffith DC, Dudley MN.

Antimicrob Agents Chemother. 2017 Oct 24;61(11). pii: e01443-17. doi: 10.1128/AAC.01443-17. Print 2017 Nov.


Carbapenem-Resistant Enterobacteriaceae Infections: Results From a Retrospective Series and Implications for the Design of Prospective Clinical Trials.

Alexander EL, Loutit J, Tumbarello M, Wunderink R, Felton T, Daikos G, Fusaro K, White D, Zhang S, Dudley MN.

Open Forum Infect Dis. 2017 Jun 1;4(2):ofx063. doi: 10.1093/ofid/ofx063. eCollection 2017 Spring.


Effects of Oritavancin on Coagulation Tests in the Clinical Laboratory.

Belley A, Robson R, Francis JL, Adcock DM, Tiefenbacher S, Rubino CM, Moeck G, Sylvester D, Dudley MN, Loutit J.

Antimicrob Agents Chemother. 2017 Jan 24;61(2). pii: e01968-16. doi: 10.1128/AAC.01968-16. Print 2017 Feb.


Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the β-Lactamase Inhibitor Vaborbactam (RPX7009) in Healthy Adult Subjects.

Griffith DC, Loutit JS, Morgan EE, Durso S, Dudley MN.

Antimicrob Agents Chemother. 2016 Sep 23;60(10):6326-32. doi: 10.1128/AAC.00568-16. Print 2016 Oct.


Results from Oritavancin Resistance Surveillance Programs (2011 to 2014): Clarification for Using Vancomycin as a Surrogate To Infer Oritavancin Susceptibility.

Jones RN, Moeck G, Arhin FF, Dudley MN, Rhomberg PR, Mendes RE.

Antimicrob Agents Chemother. 2016 Apr 22;60(5):3174-7. doi: 10.1128/AAC.03029-15. Print 2016 May.


A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients.

Flume PA, VanDevanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, Kerem E, Fischer R, Smyth AR, Aaron SD, Conrad D, Geller DE, Elborn JS.

J Cyst Fibros. 2016 Jul;15(4):495-502. doi: 10.1016/j.jcf.2015.12.004. Epub 2016 Feb 4.


Meropenem-RPX7009 Concentrations in Plasma, Epithelial Lining Fluid, and Alveolar Macrophages of Healthy Adult Subjects.

Wenzler E, Gotfried MH, Loutit JS, Durso S, Griffith DC, Dudley MN, Rodvold KA.

Antimicrob Agents Chemother. 2015 Dec;59(12):7232-9. doi: 10.1128/AAC.01713-15. Epub 2015 Sep 8.


In memoriam: William A. Craig.

Theuretzbacher U, Ambrose PG, MacGowan AP, Andes DR, Sörgel F, Derendorf H, Mouton JW, Drusano GL, Tulkens PM, Dudley MN, Cars O, Nation RL.

Antimicrob Agents Chemother. 2015;59(6):2971. doi: 10.1128/AAC.00849-15. Epub 2015 Apr 20. No abstract available.


Discovery of a Cyclic Boronic Acid β-Lactamase Inhibitor (RPX7009) with Utility vs Class A Serine Carbapenemases.

Hecker SJ, Reddy KR, Totrov M, Hirst GC, Lomovskaya O, Griffith DC, King P, Tsivkovski R, Sun D, Sabet M, Tarazi Z, Clifton MC, Atkins K, Raymond A, Potts KT, Abendroth J, Boyer SH, Loutit JS, Morgan EE, Durso S, Dudley MN.

J Med Chem. 2015 May 14;58(9):3682-92. doi: 10.1021/acs.jmedchem.5b00127. Epub 2015 Mar 17.


A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients.

Stuart Elborn J, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, Kerem E, Bell SC, Loutit JS, Dudley MN, Morgan EE, VanDevanter DR, Flume PA.

J Cyst Fibros. 2015 Jul;14(4):507-14. doi: 10.1016/j.jcf.2014.12.013. Epub 2015 Jan 13.


Framework for optimisation of the clinical use of colistin and polymyxin B: the Prato polymyxin consensus.

Nation RL, Li J, Cars O, Couet W, Dudley MN, Kaye KS, Mouton JW, Paterson DL, Tam VH, Theuretzbacher U, Tsuji BT, Turnidge JD.

Lancet Infect Dis. 2015 Feb;15(2):225-34. doi: 10.1016/S1473-3099(14)70850-3. Epub 2014 Oct 21.


Consistent global approach on reporting of colistin doses to promote safe and effective use.

Nation RL, Li J, Cars O, Couet W, Dudley MN, Kaye KS, Mouton JW, Paterson DL, Tam VH, Theuretzbacher U, Tsuji BT, Turnidge JD.

Clin Infect Dis. 2014 Jan;58(1):139-41. doi: 10.1093/cid/cit680. Epub 2013 Oct 8. No abstract available.


Commentary: revised susceptibility breakpoints: fear, loathing and good science.

Dudley MN, Ambrose PG, Jones RN.

Pediatr Infect Dis J. 2013 Sep;32(9):970-1. doi: 10.1097/INF.0b013e3182a1b8cd. No abstract available.


Background and rationale for revised clinical and laboratory standards institute interpretive criteria (Breakpoints) for Enterobacteriaceae and Pseudomonas aeruginosa: I. Cephalosporins and Aztreonam.

Dudley MN, Ambrose PG, Bhavnani SM, Craig WA, Ferraro MJ, Jones RN; Antimicrobial Susceptibility Testing Subcommittee of the Clinical and Laboratory Standards Institute.

Clin Infect Dis. 2013 May;56(9):1301-9. doi: 10.1093/cid/cit017. Epub 2013 Jan 18. Review.


Rationale for the 2010 Revised Susceptibility Breakpoints for Cephalosporins, Aztreonam, and Carbapenems for Enterobacteriaceae.

Dudley MN.

J Pediatric Infect Dis Soc. 2012 Jun;1(2):166-8. doi: 10.1093/jpids/pis046. No abstract available.


New EMA guideline for antimicrobial development.

Ambrose PG, Bhavnani SM, Dudley MN, Ellis-Grosse E, Rubino CM, Drusano GL.

Lancet Infect Dis. 2012 Apr;12(4):265-6. doi: 10.1016/S1473-3099(12)70046-4. No abstract available.


Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects.

Geller DE, Flume PA, Griffith DC, Morgan E, White D, Loutit JS, Dudley MN.

Antimicrob Agents Chemother. 2011 Jun;55(6):2636-40. doi: 10.1128/AAC.01744-10. Epub 2011 Mar 28.


Levofloxacin reduces inflammatory cytokine levels in human bronchial epithelia cells: implications for aerosol MP-376 (levofloxacin solution for inhalation) treatment of chronic pulmonary infections.

Tsivkovskii R, Sabet M, Tarazi Z, Griffith DC, Lomovskaya O, Dudley MN.

FEMS Immunol Med Microbiol. 2011 Mar;61(2):141-6. doi: 10.1111/j.1574-695X.2010.00755.x. Epub 2010 Nov 12.


Effect of oxygen limitation on the in vitro activity of levofloxacin and other antibiotics administered by the aerosol route against Pseudomonas aeruginosa from cystic fibrosis patients.

King P, Citron DM, Griffith DC, Lomovskaya O, Dudley MN.

Diagn Microbiol Infect Dis. 2010 Feb;66(2):181-6. doi: 10.1016/j.diagmicrobio.2009.09.009. Epub 2009 Oct 13.


In vitro pharmacodynamics of levofloxacin and other aerosolized antibiotics under multiple conditions relevant to chronic pulmonary infection in cystic fibrosis.

King P, Lomovskaya O, Griffith DC, Burns JL, Dudley MN.

Antimicrob Agents Chemother. 2010 Jan;54(1):143-8. doi: 10.1128/AAC.00248-09. Epub 2009 Oct 5.


Efficacy of aerosol MP-376, a levofloxacin inhalation solution, in models of mouse lung infection due to Pseudomonas aeruginosa.

Sabet M, Miller CE, Nolan TG, Senekeo-Effenberger K, Dudley MN, Griffith DC.

Antimicrob Agents Chemother. 2009 Sep;53(9):3923-8. doi: 10.1128/AAC.00268-09. Epub 2009 Jun 15.


Aerosol antibiotics: considerations in pharmacological and clinical evaluation.

Dudley MN, Loutit J, Griffith DC.

Curr Opin Biotechnol. 2008 Dec;19(6):637-43. doi: 10.1016/j.copbio.2008.11.002. Epub 2008 Nov 25. Review.


Pharmacodynamics of RWJ-54428 against Staphylococcus aureus, Streptococcus pneumoniae, and Enterococcus faecalis in a neutropenic mouse thigh infection model.

Griffith DC, Rodriguez D, Corcoran E, Dudley MN.

Antimicrob Agents Chemother. 2008 Jan;52(1):244-7. Epub 2007 Oct 22.


Quinazolinone fungal efflux pump inhibitors. Part 3: (N-methyl)piperazine variants and pharmacokinetic optimization.

Watkins WJ, Chong L, Cho A, Hilgenkamp R, Ludwikow M, Garizi N, Iqbal N, Barnard J, Singh R, Madsen D, Lolans K, Lomovskaya O, Oza U, Kumaraswamy P, Blecken A, Bai S, Loury DJ, Griffith DC, Dudley MN.

Bioorg Med Chem Lett. 2007 May 15;17(10):2802-6. Epub 2007 Feb 27.


Pharmacodynamics of levofloxacin against Pseudomonas aeruginosa with reduced susceptibility due to different efflux pumps: do elevated MICs always predict reduced in vivo efficacy?

Griffith DC, Corcoran E, Lofland D, Lee A, Cho D, Lomovskaya O, Dudley MN.

Antimicrob Agents Chemother. 2006 May;50(5):1628-32.


Antimicrobial drug resistance, regulation, and research.

Metlay JP, Powers JH, Dudley MN, Christiansen K, Finch RG.

Emerg Infect Dis. 2006 Feb;12(2):183-90.


Outcomes evaluation of patients with ESBL- and non-ESBL-producing Escherichia coli and Klebsiella species as defined by CLSI reference methods: report from the SENTRY Antimicrobial Surveillance Program.

Bhavnani SM, Ambrose PG, Craig WA, Dudley MN, Jones RN; SENTRY Antimicrobial Surveillance Program.

Diagn Microbiol Infect Dis. 2006 Mar;54(3):231-6. Epub 2006 Jan 19.


Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for anti-infective drugs: an update.

Mouton JW, Dudley MN, Cars O, Derendorf H, Drusano GL.

J Antimicrob Chemother. 2005 May;55(5):601-7. Epub 2005 Mar 16. Review.


Quinazolinone fungal efflux pump inhibitors. Part 2: In vitro structure-activity relationships of (N-methyl-piperazinyl)-containing derivatives.

Watkins WJ, Lemoine RC, Chong L, Cho A, Renau TE, Kuo B, Wong V, Ludwikow M, Garizi N, Iqbal N, Barnard J, Jankowska R, Singh R, Madsen D, Lolans K, Lomovskaya O, Oza U, Dudley MN.

Bioorg Med Chem Lett. 2004 Oct 18;14(20):5133-7.


Quinazolinone-based fungal efflux pump inhibitors. Part 1: Discovery of an (N-methylpiperazine)-containing derivative with activity in clinically relevant Candida spp.

Lemoine RC, Glinka TW, Watkins WJ, Cho A, Yang J, Iqbal N, Singh R, Madsen D, Lolans K, Lomovskaya O, Oza U, Dudley MN.

Bioorg Med Chem Lett. 2004 Oct 18;14(20):5127-31.


The relationship between physicochemical properties, in vitro activity and pharmacokinetic profiles of analogues of diamine-containing efflux pump inhibitors.

Watkins WJ, Landaverry Y, Léger R, Litman R, Renau TE, Williams N, Yen R, Zhang JZ, Chamberland S, Madsen D, Griffith D, Tembe V, Huie K, Dudley MN.

Bioorg Med Chem Lett. 2003 Dec 1;13(23):4241-4.


Predicting efficacy of antiinfectives with pharmacodynamics and Monte Carlo simulation.

Bradley JS, Dudley MN, Drusano GL.

Pediatr Infect Dis J. 2003 Nov;22(11):982-92; quiz 993-5. Review. No abstract available.


Conformationally-restricted analogues of efflux pump inhibitors that potentiate the activity of levofloxacin in Pseudomonas aeruginosa.

Renau TE, Léger R, Filonova L, Flamme EM, Wang M, Yen R, Madsen D, Griffith D, Chamberland S, Dudley MN, Lee VJ, Lomovskaya O, Watkins WJ, Ohta T, Nakayama K, Ishida Y.

Bioorg Med Chem Lett. 2003 Aug 18;13(16):2755-8.


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