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12. What's Really New in Antibiotic Therapy Print What’s really new in antibiotic therapy? Martin J. Hug Freiburg University Medical Center EAHP Academy Seminars 20-21 September 2019 Newsweek, May 24-31 2019 Disclosures There are no conflicts of interest to declare EAHP Academy Seminars 20-21 September 2019 Antiinfectives and Resistance EAHP Academy Seminars 20-21 September 2019 Resistance of Klebsiella pneumoniae to Pip.-Taz. olates) EAHP Academy Seminars 20-21 September 2019 https://resistancemap.cddep.org/AntibioticResistance.php Multiresistant Pseudomonas Aeruginosa Combined resistance against at least three different types of antibiotics, 2017 EAHP Academy Seminars 20-21 September 2019 https://atlas.ecdc.europa.eu/public/index.aspx Distribution of ESBL producing Enterobacteriaceae EAHP Academy Seminars 20-21 September 2019 Rossolini GM. Global threat of Gram-negative antimicrobial resistance. 27th ECCMID, Vienna, 2017, IS07 Priority Pathogens Defined by the World Health Organisation Critical Priority High Priority Medium Priority Acinetobacter baumanii Enterococcus faecium Streptococcus pneumoniae carbapenem-resistant vancomycin-resistant penicillin-non-susceptible Pseudomonas aeruginosa Helicobacter pylori Haemophilus influenzae carbapenem-resistant clarithromycin-resistant ampicillin-resistant Enterobacteriaceae Salmonella species Shigella species carbapenem-resistant fluoroquinolone-resistant fluoroquinolone-resistant Staphylococcus aureus vancomycin or methicillin -resistant Campylobacter species fluoroquinolone-resistant Neisseria gonorrhoae 3rd gen. cephalosporin-resistant fluoroquinolone-resistant EAHP Academy Seminars 20-21 September 2019 Data taken from: https://www.who.int/foodsafety/publications/antimicrobials-sixth/en/ Antibacterial Targets EAHP Academy Seminars 20-21 September 2019 Resistance mechanisms EAHP Academy Seminars 20-21 September 2019 Mukerji S et al. Essays In Biochemistry 2017, 61(1) 23-35 Veterinary and Human use of Antibiotics Them or us? Aminoglycosides Carbapenems Cephalosporins Glycopeptides Diaminopyridines Lipopeptides Fluoroquinolones Monobactams Lincosamides Oxazolidinones Pleuromutilins Macrolides Streptogramins Penicillins Phenicoles Polymyxins Sulfonamides Tetracyclins EAHP Academy Seminars 20-21 September 2019 Data taken from: https://www.bvl.bund.de/SharedDocs/Downloads/ 07_Bundesamt/Veranstaltungen/Symposium2013/symposium2013_vortrag_wallmann.pdf Use Density of Critically Important Antibiotics in German Hospitals Data: ADKA if DGI antibiotic surveillance project 2,5 Meropenem Vancomycin Imipenem + Cilastatin 2 Linezolid Tigecyclin Daptomycin Other 1,5 1 RDD/100 Pt. Days 0,5 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 EAHP Academy Seminars 20-21 September 2019 Use Density of Novel Cephalosporins in German Hospitals Data: ADKA if DGI antibiotic surveillance project 0,04 Sum Ceftazidim + Avibactam Ceftolozan + Tazobactam 0,03 Ceftarolin Ceftibuten 0,02 RDD/100 Pt. Days 0,01 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 EAHP Academy Seminars 20-21 September 2019 Development Pipeline of Antibiotic Drugs 16 14 12 10 8 Count 6 4 2 0 Phase 1 Phase 2 Phase 3 New drug Approved application EAHP Academy Seminars 20-21 September 2019 Data: https://www.pewtrusts.org/-/media/assets/2019/03/antibiotics-currently-in-global-clinical-development.pdf Novel Antibiotics (a selection) • Long acting Glycopeptides • ß-lactams • ß-lactams + ß-lactam inhibitors • Pleuromutilines • LpxC Inhibitors • Bacteriophages • Fecal Microbiome Transfer EAHP Academy Seminars 20-21 September 2019 Antiinfective drugs – already FDA / EMA approved Gram-positive bacteria Gram-negative bacteria DALBAVANCIN (DalvanceTM/ Xydalba®) CEFTOBIPROL (Zevtera®) CEFTOLOZAN-TAZOBACTAM ORITAVANCIN (OrbactivTM) (ZerbaxaTM) ® TEDIZOLID (Sivextro ) CEFTAZIDIM-AVIBACTAM CEFTOBIPROL (Zevtera®) (AvycazTM/ Zavicefta®) EAHP Academy Seminars 20-21 September 2019 Antibacterial Targets Inhibitors of cell wall assembly * *Glycopeptides EAHP Academy Seminars 20-21 September 2019 Novel Approved Antiinfectives: Glycopeptides Vancomycin Dalbavancin Oritavancin EAHP Academy Seminars 20-21 September 2019 Clinical response to Dalbavancin Acute bacterial skin and skin-structure infection 100 90 n = 573 n = 836 Dalbavancin 0,5g 1x day 1 80 and day 8 70 Vancomycin 2x1g / patients 60 Linezolid 2x600 mg daily of 50 40 30 20 10 Percentage 0 Outcome DISCOVER 1 Outcome DISCOVER 2 Side effects DISCOVER 1 EAHP Academy Seminars 20-21 September 2019 Data taken from: Boucher H et al. N Engl J Med 2014;370:2169-79 Clinical response to Oritavancin Acute bacterial skin and skin-structure infection 100 n = 791 Oritavancin 1,2g 1x 90 Single Shot 80 70 Vancomycin 2x1g patients 60 daily for 7-10 days of 50 n = 591 40 30 20 Percentage 10 0 Primary endpoint Secondary endpoint Tertiary endpoint Side effects EAHP Academy Seminars 20-21 September 2019 Data: Corey CG et al. N Engl J Med 2014;370:2180-90 Take Home Message • Dalbavancin and Oritavancin are novel Glycopeptide antibiotics to treat infections caused by gram-positive bacteria. • Oritavancin and Dalbavancin have an apparent half-life of 10 – 15 days respectively, which permits a single dosing regime. • Both substances are aproved for the treatment of acute bacterial skin, skin- structure and soft tissue infections. • To this end no data exist to demonstrate a clinical benefit compared to established Glycopeptides other than better treatment options in the outpatient sector. EAHP Academy Seminars 20-21 September 2019 Antibacterial Targets Inhibitors of cell wall assembly * *Cephalosporins EAHP Academy Seminars 20-21 September 2019 Novel Antiinfectives: Cephalosporins (O) = oral use 1st Generation 2nd Generation 3rd Generation 4th Generation Cefazolin Cefamandole Cefoperazone Cefepime Cephalothin Cefonicid Cefotaxime Cefpirome Cefadroxil (O) Cefuroxime (-axetil (O)) Ceftazidime Cephalexin (O) Cefaclor (O) Ceftizoxime Cephradine (O) Cefprozil (O) Ceftriaxone Loracarbef (O) Moxalactam Cefdinir (O) Cefmetazole Cefditoren (O) Cefotetan Cefixime (O) 5th Generation Cefoxitin Cefpodoxime (O) Ceftarolin Ceftibuten (O) Ceftobiprol EAHP Academy Seminars 20-21 September 2019 Cefiderocol – same same but different Ceftazidime Cefepime Cefiderocol 3+ Fe EAHP Academy Seminars 20-21 September 2019 Porin Specific Entry of Cefiderocol Fe3+ Fe3+ Transporter EAHP Academy Seminars 20-21 September 2019 Uptake of Cefiderocol in Iron-depleted Conditions Cefiderocol uptake into P. aeruginosa cells was >2 times higher under low iron conditions 100 80 Iron-depleted conditions (SD) Iron-rich conditions 625 60 /0.1 of OD 40 pmol 20 Uptake, 0 0 5 10 OD, optical density; SD, standard deviation Time, min EAHP Academy Seminars 20-21 September 2019 Ito A, et al. Antimicrob Agents Chemother 2016;60:7396–401 Cefiderocol in Complicated Urinary Tract Infections Trial design Patients assesed for eligibility: n=495 RandomisedExcluded: n:=43 n=452 Imipenem-cilastatin: n=149 Cefiderocol: n=303 Completed in ITT population: n=242 Completed in ITT population: n=249 Endpoints: 1. clinical and microbiological response; 2. safety, clinical and microbiological response at early assessment EAHP Academy Seminars 20-21 September 2019 Mod. from Portsmouth S et al. Lancet Infect Dis. 2018(12):1319-1328 Cefiderocol in Complicated Urinary Tract Infections Distribution of pathogens isolated at baseline EAHP Academy Seminars 20-21 September 2019 Mod. from Portsmouth S et al. Lancet Infect Dis. 2018(12):1319-1328 Cefiderocol in Complicated Urinary Tract Infections Results EAHP Academy Seminars 20-21 September 2019 Mod. from Portsmouth S et al. Lancet Infect Dis. 2018(12):1319-1328 Novel Antiinfectives: Combination of Cephalosporines with ß-Lactamase Inhibitors Sulbactam Tazobactam Avibactam Ceftolozan Ceftazidime EAHP Academy Seminars 20-21 September 2019 Susceptibility of Different Carbapenem-resistant Pseudomonas Strains in Spain CXA-101 = Ceftolozan CAZ = Ceftazidime FEP = Cefepime EAHP Academy Seminars 20-21 September 2019 Juan C et al. Antimicrob. Agents Chemother. 2010;54:846-851 Clinical Response to Ceftolozan-Tazobactam Acute abdominal infections 100 90 Ceftolozan 1g+Tazobactam 80 0,5g+Metronidazol 0,5g 70 Meropenem 0,5g patients 60 of 3 x daily each 50 40 30 20 10 Percentage 0 Primary endpoint Secondary endpoint Side effects EAHP Academy Seminars 20-21 September 2019 Data from: Solomkin J et al. Clin Infect Dis 2015;60(10):1462–71 Novel Antiinfectives: Combination of Cephalosporines with ß-Lactamase Inhibitors Sulbactam Tazobactam Avibactam Ceftolozan Ceftazidime EAHP Academy Seminars 20-21 September 2019 Clinical Response to Ceftazidime-Avibactam Acute abdominal infections 100 Ceftazidime 2g+Avibactam 90 0.5g+Metronidazol 0.5g 80 Meropenem 0.5g 70 patients 60 of 50 40 30 20 10 Percentage 0 All bacteria Gramnegative Side effects EAHP Academy Seminars 20-21 September 2019 Data from: Lucasti C et al. J Antimicrob Chemother 2013; 68: 1183–1192 Clinical Response to Ceftazidime-Avibactam Complicated urinary tract infections 100 Ceftazidime 2g+Avibactam 0,5g 3x daily 90 80 Imipenem/Cilastatin 0,5g 4x daily 70 patients 60 of 50 40 30 20 10 Percentage 0 All bacteria Gramnegative Side effects EAHP Academy Seminars 20-21 September 2019 Data from: Vasquez JA et al. Curr Med Res Opin. 2012;28(12):1921-31 Combinations of ß-lactams and BLI Ongoing Clinical Trials Vabor- Avibactam Nacubactam Relebactam Zidebactam bactam Diazabi- Diazabi- Diazabi- Cyclic Diazabi- cyclooctane cyclooctane cyclooctane boronate cyclooctane Aztreonam X* Cefepime X Imipenem- X Cilastatin Meropenem X X* *FDA approved EAHP
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