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Antibiotic development - economic, regulatory and societal challenges.

Årdal C, Balasegaram M, Laxminarayan R, McAdams D, Outterson K, Rex JH, Sumpradit N.

Nat Rev Microbiol. 2019 Nov 19. doi: 10.1038/s41579-019-0293-3. [Epub ahead of print] Review. No abstract available.


Designing development programs for non-traditional antibacterial agents.

Rex JH, Fernandez Lynch H, Cohen IG, Darrow JJ, Outterson K.

Nat Commun. 2019 Jul 31;10(1):3416. doi: 10.1038/s41467-019-11303-9. Review.


Pharmacokinetic-Pharmacodynamic Evaluation of Ertapenem for Patients with Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia.

Bader JC, Lakota EA, Dale GE, Sader HS, Rex JH, Ambrose PG, Bhavnani SM.

Antimicrob Agents Chemother. 2019 May 24;63(6). pii: e00318-19. doi: 10.1128/AAC.00318-19. Print 2019 Jun.


Efficacy of Olorofim (F901318) against Aspergillus fumigatus, A. nidulans, and A. tanneri in Murine Models of Profound Neutropenia and Chronic Granulomatous Disease.

Seyedmousavi S, Chang YC, Law D, Birch M, Rex JH, Kwon-Chung KJ.

Antimicrob Agents Chemother. 2019 May 24;63(6). pii: e00129-19. doi: 10.1128/AAC.00129-19. Print 2019 Jun.


Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials.

Weiss E, Zahar JR, Alder J, Asehnoune K, Bassetti M, Bonten MJM, Chastre J, De Waele J, Dimopoulos G, Eggimann P, Engelhardt M, Ewig S, Kollef M, Lipman J, Luna C, Martin-Loeches I, Pagani L, Palmer LB, Papazian L, Poulakou G, Prokocimer P, Rello J, Rex JH, Shorr AF, Talbot GH, Thamlikitkul V, Torres A, Wunderink RG, Timsit JF.

Clin Infect Dis. 2019 Nov 13;69(11):1912-1918. doi: 10.1093/cid/ciz093.


The successful uptake and sustainability of rapid infectious disease and antimicrobial resistance point-of-care testing requires a complex 'mix-and-match' implementation package.

Hays JP, Mitsakakis K, Luz S, van Belkum A, Becker K, van den Bruel A, Harbarth S, Rex JH, Simonsen GS, Werner G, Di Gregori V, Lüdke G, van Staa T, Moran-Gilad J, Bachmann TT; JPIAMR AMR-RDT consortium.

Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1015-1022. doi: 10.1007/s10096-019-03492-4. Epub 2019 Feb 2. Review.


Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.

Talbot GH, Das A, Cush S, Dane A, Wible M, Echols R, Torres A, Cammarata S, Rex JH, Powers JH, Fleming T, Loutit J, Hoffmann S; Foundation for the National Institutes of Health Biomarkers Consortium HABP/VABP Project Team.

J Infect Dis. 2019 Apr 19;219(10):1536-1544. doi: 10.1093/infdis/jiy578.


Analysis of the clinical antibacterial and antituberculosis pipeline.

Theuretzbacher U, Gottwalt S, Beyer P, Butler M, Czaplewski L, Lienhardt C, Moja L, Paul M, Paulin S, Rex JH, Silver LL, Spigelman M, Thwaites GE, Paccaud JP, Harbarth S.

Lancet Infect Dis. 2019 Feb;19(2):e40-e50. doi: 10.1016/S1473-3099(18)30513-9. Epub 2018 Oct 15. Review.


Developmental roadmap for antimicrobial susceptibility testing systems.

van Belkum A, Bachmann TT, Lüdke G, Lisby JG, Kahlmeter G, Mohess A, Becker K, Hays JP, Woodford N, Mitsakakis K, Moran-Gilad J, Vila J, Peter H, Rex JH, Dunne WM Jr; JPIAMR AMR-RDT Working Group on Antimicrobial Resistance and Rapid Diagnostic Testing.

Nat Rev Microbiol. 2019 Jan;17(1):51-62. doi: 10.1038/s41579-018-0098-9. Review.


The Orotomide Olorofim Is Efficacious in an Experimental Model of Central Nervous System Coccidioidomycosis.

Wiederhold NP, Najvar LK, Jaramillo R, Olivo M, Birch M, Law D, Rex JH, Catano G, Patterson TF.

Antimicrob Agents Chemother. 2018 Aug 27;62(9). pii: e00999-18. doi: 10.1128/AAC.00999-18. Print 2018 Sep.


Editorial overview: Use of PK-PD for antibacterial drug development: decreasing risk and paths forward for resistant pathogens.

Bhavnani SM, Rex JH.

Curr Opin Pharmacol. 2017 Oct;36:viii-xii. doi: 10.1016/j.coph.2017.11.008. No abstract available.


Reply to Paul and Leibovici.

Boucher HW, Ambrose PG, Chambers HF, Ebright RH, Jezek A, Murray BE, Ostrowsky B, Rex JH.

J Infect Dis. 2018 Jan 17;217(3):509-510. doi: 10.1093/infdis/jix537. No abstract available.


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.


Time for a change in how new antibiotics are reimbursed: Development of an insurance framework for funding new antibiotics based on a policy of risk mitigation.

Towse A, Hoyle CK, Goodall J, Hirsch M, Mestre-Ferrandiz J, Rex JH.

Health Policy. 2017 Oct;121(10):1025-1030. doi: 10.1016/j.healthpol.2017.07.011. Epub 2017 Aug 5.


Pharmacodynamics of the Orotomides against Aspergillus fumigatus: New Opportunities for Treatment of Multidrug-Resistant Fungal Disease.

Hope WW, McEntee L, Livermore J, Whalley S, Johnson A, Farrington N, Kolamunnage-Dona R, Schwartz J, Kennedy A, Law D, Birch M, Rex JH.

mBio. 2017 Aug 22;8(4). pii: e01157-17. doi: 10.1128/mBio.01157-17.


To the G20: incentivising antibacterial research and development.

Årdal C, Baraldi E, Ciabuschi F, Outterson K, Rex JH, Piddock LJV, Findlay D; DRIVE-AB Steering Committee.

Lancet Infect Dis. 2017 Aug;17(8):799-801. doi: 10.1016/S1473-3099(17)30404-8. Epub 2017 Jul 7. No abstract available.


White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs.

Boucher HW, Ambrose PG, Chambers HF, Ebright RH, Jezek A, Murray BE, Newland JG, Ostrowsky B, Rex JH; Infectious Diseases Society of America.

J Infect Dis. 2017 Jul 15;216(2):228-236. doi: 10.1093/infdis/jix211. Review.


Pharmacodynamics for antifungal drug development: an approach for acceleration, risk minimization and demonstration of causality.

Hope W, Drusano GL, Rex JH.

J Antimicrob Chemother. 2016 Nov;71(11):3008-3019. Epub 2016 Aug 5. Review.


Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.

McDonnell A, Rex JH, Goossens H, Bonten M, Fowler VG Jr, Dane A.

Clin Infect Dis. 2016 Aug 15;63 Suppl 2:S57-9. doi: 10.1093/cid/ciw244. Review.


Accelerating global innovation to address antibacterial resistance: introducing CARB-X.

Outterson K, Rex JH, Jinks T, Jackson P, Hallinan J, Karp S, Hung DT, Franceschi F, Merkeley T, Houchens C, Dixon DM, Kurilla MG, Aurigemma R, Larsen J.

Nat Rev Drug Discov. 2016 Sep;15(9):589-590. doi: 10.1038/nrd.2016.155. Epub 2016 Jul 29.


Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach.

Rex JH, Outterson K.

Lancet Infect Dis. 2016 Apr;16(4):500-5. doi: 10.1016/S1473-3099(15)00500-9. Review.


Alternatives to antibiotics-a pipeline portfolio review.

Czaplewski L, Bax R, Clokie M, Dawson M, Fairhead H, Fischetti VA, Foster S, Gilmore BF, Hancock RE, Harper D, Henderson IR, Hilpert K, Jones BV, Kadioglu A, Knowles D, Ólafsdóttir S, Payne D, Projan S, Shaunak S, Silverman J, Thomas CM, Trust TJ, Warn P, Rex JH.

Lancet Infect Dis. 2016 Feb;16(2):239-51. doi: 10.1016/S1473-3099(15)00466-1. Epub 2016 Jan 13. Review.


The challenge of antimicrobial resistance: new regulatory tools to support product development.

Tomayko JF, Rex JH, Tenero DM, Goldberger M, Eisenstein BI.

Clin Pharmacol Ther. 2014 Aug;96(2):166-8. doi: 10.1038/clpt.2014.107. Epub 2014 May 13. Review.


The evolution of the regulatory framework for antibacterial agents.

Rex JH, Goldberger M, Eisenstein BI, Harney C.

Ann N Y Acad Sci. 2014 Sep;1323:11-21. doi: 10.1111/nyas.12441. Epub 2014 May 2. Review.


The value of single-pathogen antibacterial agents.

Spellberg B, Rex JH.

Nat Rev Drug Discov. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15. No abstract available.


Addressing the need for new antibacterials--authors' reply.

Rex JH, Eisenstein BI, Alder J, Goldberger M, Meyer R, Dane A, Friedland I, Knirsch C, Sanhai WR, Tomayko J, Lancaster C, Jackson J.

Lancet Infect Dis. 2013 Oct;13(10):834-5. doi: 10.1016/S1473-3099(13)70256-1. No abstract available.


A comprehensive regulatory framework to address the unmet need for new antibacterial treatments.

Rex JH, Eisenstein BI, Alder J, Goldberger M, Meyer R, Dane A, Friedland I, Knirsch C, Sanhai WR, Tomayko J, Lancaster C, Jackson J.

Lancet Infect Dis. 2013 Mar;13(3):269-75. doi: 10.1016/S1473-3099(12)70293-1. Epub 2013 Jan 15.


Safety and tolerability of voriconazole in patients with baseline renal insufficiency and candidemia.

Oude Lashof AM, Sobel JD, Ruhnke M, Pappas PG, Viscoli C, Schlamm HT, Rex JH, Kullberg BJ.

Antimicrob Agents Chemother. 2012 Jun;56(6):3133-7. doi: 10.1128/AAC.05841-11. Epub 2012 Mar 26.


Impact of treatment strategy on outcomes in patients with candidemia and other forms of invasive candidiasis: a patient-level quantitative review of randomized trials.

Andes DR, Safdar N, Baddley JW, Playford G, Reboli AC, Rex JH, Sobel JD, Pappas PG, Kullberg BJ; Mycoses Study Group.

Clin Infect Dis. 2012 Apr;54(8):1110-22. doi: 10.1093/cid/cis021. Epub 2012 Mar 12.


The critical impact of time discounting on economic incentives to overcome the antibiotic market failure.

Spellberg B, Sharma P, Rex JH.

Nat Rev Drug Discov. 2012 Feb 1;11(2):168. doi: 10.1038/nrd3560-c1. No abstract available.


European expert opinion on the management of invasive candidiasis in adults.

Kullberg BJ, Verweij PE, Akova M, Arendrup MC, Bille J, Calandra T, Cuenca-Estrella M, Herbrecht R, Jacobs F, Kalin M, Kibbler CC, Lortholary O, Martino P, Meis JF, Muñoz P, Odds FC, De Pauw BE, Rex JH, Roilides E, Rogers TR, Ruhnke M, Ullmann AJ, Uzun Ö, Vandewoude K, Vincent JL, Donnelly JP.

Clin Microbiol Infect. 2011 Sep;17 Suppl 5:1-12. doi: 10.1111/j.1469-0691.2011.03615.x.


Ocular manifestations of candidemia.

Oude Lashof AM, Rothova A, Sobel JD, Ruhnke M, Pappas PG, Viscoli C, Schlamm HT, Oborska IT, Rex JH, Kullberg BJ.

Clin Infect Dis. 2011 Aug 1;53(3):262-8. doi: 10.1093/cid/cir355.


Prospective survey of (1→3)-beta-D-glucan and its relationship to invasive candidiasis in the surgical intensive care unit setting.

Mohr JF, Sims C, Paetznick V, Rodriguez J, Finkelman MA, Rex JH, Ostrosky-Zeichner L.

J Clin Microbiol. 2011 Jan;49(1):58-61. doi: 10.1128/JCM.01240-10. Epub 2010 Nov 3.


An insight into the antifungal pipeline: selected new molecules and beyond.

Ostrosky-Zeichner L, Casadevall A, Galgiani JN, Odds FC, Rex JH.

Nat Rev Drug Discov. 2010 Sep;9(9):719-27. doi: 10.1038/nrd3074. Epub 2010 Aug 20. Review.


Wild-type MIC distribution and epidemiological cutoff values for Aspergillus fumigatus and three triazoles as determined by the Clinical and Laboratory Standards Institute broth microdilution methods.

Pfaller MA, Diekema DJ, Ghannoum MA, Rex JH, Alexander BD, Andes D, Brown SD, Chaturvedi V, Espinel-Ingroff A, Fowler CL, Johnson EM, Knapp CC, Motyl MR, Ostrosky-Zeichner L, Sheehan DJ, Walsh TJ; Clinical and Laboratory Standards Institute Antifungal Testing Subcommittee.

J Clin Microbiol. 2009 Oct;47(10):3142-6. doi: 10.1128/JCM.00940-09. Epub 2009 Aug 19.


Lack of correlation of 24- vs. 48-h itraconazole minimum inhibitory concentrations with microbiological and survival outcomes in a guinea pig model of disseminated candidiasis.

Odabasi Z, Paetznick VL, Rodriguez JR, Chen E, Rex JH, Leitz GJ, Ostrosky-Zeichner L.

Mycoses. 2010 Sep;53(5):438-42. doi: 10.1111/j.1439-0507.2009.01733.x. Epub 2009 Jun 4.


Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America.

Pappas PG, Kauffman CA, Andes D, Benjamin DK Jr, Calandra TF, Edwards JE Jr, Filler SG, Fisher JF, Kullberg BJ, Ostrosky-Zeichner L, Reboli AC, Rex JH, Walsh TJ, Sobel JD; Infectious Diseases Society of America.

Clin Infect Dis. 2009 Mar 1;48(5):503-35. doi: 10.1086/596757.


Rationale for reading fluconazole MICs at 24 hours rather than 48 hours when testing Candida spp. by the CLSI M27-A2 standard method.

Ostrosky-Zeichner L, Rex JH, Pfaller MA, Diekema DJ, Alexander BD, Andes D, Brown SD, Chaturvedi V, Ghannoum MA, Knapp CC, Sheehan DJ, Walsh TJ.

Antimicrob Agents Chemother. 2008 Nov;52(11):4175-7. doi: 10.1128/AAC.00420-08. Epub 2008 Sep 22.


Empirical fluconazole versus placebo for intensive care unit patients: a randomized trial.

Schuster MG, Edwards JE Jr, Sobel JD, Darouiche RO, Karchmer AW, Hadley S, Slotman G, Panzer H, Biswas P, Rex JH.

Ann Intern Med. 2008 Jul 15;149(2):83-90.


Correlation of MIC with outcome for Candida species tested against caspofungin, anidulafungin, and micafungin: analysis and proposal for interpretive MIC breakpoints.

Pfaller MA, Diekema DJ, Ostrosky-Zeichner L, Rex JH, Alexander BD, Andes D, Brown SD, Chaturvedi V, Ghannoum MA, Knapp CC, Sheehan DJ, Walsh TJ.

J Clin Microbiol. 2008 Aug;46(8):2620-9. doi: 10.1128/JCM.00566-08. Epub 2008 Jun 25.


Multilaboratory testing of antifungal combinations against a quality control isolate of Candida krusei.

Chaturvedi V, Ramani R, Ghannoum MA, Killian SB, Holliday N, Knapp C, Ostrosky-Zeichner L, Messer SA, Pfaller MA, Iqbal NJ, Arthington-Skaggs BA, Vazquez JA, Sein T, Rex JH, Walsh TJ.

Antimicrob Agents Chemother. 2008 Apr;52(4):1500-2. doi: 10.1128/AAC.00574-07. Epub 2008 Jan 28.


Effects of serum on in vitro susceptibility testing of echinocandins.

Odabasi Z, Paetznick V, Rex JH, Ostrosky-Zeichner L.

Antimicrob Agents Chemother. 2007 Nov;51(11):4214-6. Epub 2007 Sep 4.


Does one voriconazole breakpoint suit all Candida species?

Arendrup MC, Denning DW, Pfaller MA, Diekema DJ, Rex JH.

J Clin Microbiol. 2007 Jun;45(6):2093; author reply 2094. No abstract available.


Multicenter retrospective development and validation of a clinical prediction rule for nosocomial invasive candidiasis in the intensive care setting.

Ostrosky-Zeichner L, Sable C, Sobel J, Alexander BD, Donowitz G, Kan V, Kauffman CA, Kett D, Larsen RA, Morrison V, Nucci M, Pappas PG, Bradley ME, Major S, Zimmer L, Wallace D, Dismukes WE, Rex JH.

Eur J Clin Microbiol Infect Dis. 2007 Apr;26(4):271-6.


Galactomannan and the diagnosis of invasive aspergillosis.

Rex JH.

Clin Infect Dis. 2006 May 15;42(10):1428-30. Epub 2006 Apr 14. No abstract available.


Antifungal prophylaxis in the intensive care unit: who should get it?

Rex JH.

Crit Care Med. 2006 Apr;34(4):1286-7. No abstract available.


Correlation of MIC with outcome for Candida species tested against voriconazole: analysis and proposal for interpretive breakpoints.

Pfaller MA, Diekema DJ, Rex JH, Espinel-Ingroff A, Johnson EM, Andes D, Chaturvedi V, Ghannoum MA, Odds FC, Rinaldi MG, Sheehan DJ, Troke P, Walsh TJ, Warnock DW.

J Clin Microbiol. 2006 Mar;44(3):819-26.


Candida in the peritoneum: passenger or pathogen?

Rex JH.

Crit Care Med. 2006 Mar;34(3):902-3. No abstract available.


International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia.

Ostrosky-Zeichner L, Kontoyiannis D, Raffalli J, Mullane KM, Vazquez J, Anaissie EJ, Lipton J, Jacobs P, van Rensburg JH, Rex JH, Lau W, Facklam D, Buell DN.

Eur J Clin Microbiol Infect Dis. 2005 Oct;24(10):654-61. Erratum in: Eur J Clin Microbiol Infect Dis. 2006 Jan;25(1):69.


Voriconazole versus a regimen of amphotericin B followed by fluconazole for candidaemia in non-neutropenic patients: a randomised non-inferiority trial.

Kullberg BJ, Sobel JD, Ruhnke M, Pappas PG, Viscoli C, Rex JH, Cleary JD, Rubinstein E, Church LW, Brown JM, Schlamm HT, Oborska IT, Hilton F, Hodges MR.

Lancet. 2005 Oct 22-28;366(9495):1435-42.


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