328
Views
12
CrossRef citations to date
0
Altmetric
Drug Profile

Plazomicin: an intravenous aminoglycoside antibacterial for the treatment of complicated urinary tract infections

ORCID Icon, &
Pages 705-720 | Received 26 Feb 2020, Accepted 20 Apr 2020, Published online: 13 May 2020

References

  • Aslam B, Wang W, Arshad MI, et al. Antibiotic resistance: a rundown of a global crisis. Infect Drug Resist. 2018;11:1645–1658.
  • CDC. Antibiotic resistance threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019.
  • Thorpe KE, Joski P, Johnston KJ. Antibiotic-resistant infection treatment costs have doubled since 2002, now exceeding $2 billion annually. Health Aff. 2018;37(4):662–669.
  • Kaye KS, Pogue JM. Infections caused by resistant gram-negative bacteria: epidemiology and management. Pharmacotherapy. 2015;35(10):949–962.
  • Exner M, Bhattacharya S, Christiansen B, et al. Antibiotic resistance: what is so special about multidrug-resistant gram-negative bacteria? GMS Hyg Infect Control. 2017;12:1–24.
  • Gupta V, Ye G, Olesky M, et al. National prevalence estimates for resistant enterobacteriaceae and acinetobacter species in hospitalized patients in the United States. Int J Infect Dis. 2019;85:203–211.
  • Gupta V, Ye G, Olesky M, et al. Trends in resistant enterobacteriaceae and acinetobacter species in hospitalized patients in the United States: 2013–2017. BMC Infect Dis. 2019;19(1):1–9.
  • CRE Technical Information. Centers for disease control and prevention. [Updated 2019 Nov 22; cited 2019 Dec 15]. Available from: https://www.cdc.gov/hai/organisms/cre/technical-info.html.
  • Patel G, Huprikar S, Factor SH, et al. Outcomes of carbapenem-resistant Klebsiella pneumoniae infection and the impact of antimicrobial and adjunctive therapies. Infect Control Hosp Epidemiol. 2008;29(12):1099–1106.
  • Yigit H, Queenan AM, Anderson GJ, et al. Novel carbapenem-hydrolyzing beta-lactamase, KPC-1 from a carbapenem-resistant strain of Klebsiella pneumoniae. Antimicrob Agents Chemother. 2001;45(4):1151–1161.
  • Tracking CRE in the United States. Centers for Disease Control and Prevention. Updated 2019 Nov 1. [cited 2019 Nov 28]. https://www.cdc.gov/hai/organisms/cre/trackingcre.html.
  • Partridge SR. Resistance mechanisms in Enterobacteriaceae. Pathology. 2015;47(3):276–284.
  • Ramirez MS, Tolmasky ME. Aminoglycoside modifying enzymes. Drug Resist Updat. 2010;13(6):151–171.
  • Davies J, Wright GD. Bacterial resistance to aminoglycoside antibiotics. Trends Microbiol. 1997;5(6):234–239.
  • Shaw KJ, Rather PN, Hare RS, et al. Molecular genetics of aminoglycoside resistance genes and familial relationships of the aminoglycoside-modifying enzymes. Microbiol Rev. 2001;45(4):1151–1161.
  • Partridge SR, Tsafnat G, Coiera E, et al. Gene cassettes and cassette arrays in mobile resistance integrons. FEMS Microbiol Rev. 2009;33(4):757–784.
  • Fernandez-Rodriguez A, Canton R, Perez-Diaz JC, et al. Aminoglycoside-modifying enzymes in clinical isolates harboring extended-spectrum beta-lactamases. Antimicrob Agents Chemother. 1992;36(11):2536–2538.
  • Ode T, Saito R, Kumita W, et al. Analysis of plasmid-mediated multidrug resistance in Escherichia coli and Klebsiella oxytoca isolates from clinical specimens in Japan. Int J Antimicrob Agents. 2009;34(4):347–350.
  • Wei DD, Wan LG, Yu Y, et al. Characterization of extended-spectrum beta-lactamase, carbapenemase, and plasmid quinolone determinants in Klebsiella pneumoniae isolates carrying distinct types of 16S rRNA methylase genes, and their association with mobile genetic elements. Microb Drug Resist. 2015;21(2):186–193.
  • Partridge SR, Thomas LC, Ginn AN, et al. A novel gene cassette, aacA43, in a plasmid-borne class 1 integron. Antimicrob Agents Chemother. 2011;55(6):2979–2982.
  • Huang S, Dai W, Sun S, et al. Prevalence of plasmid-mediated quinolone resistance and aminoglycoside resistance determinants among carbapeneme non-susceptible Enterobacter cloacae. PLoS One. 2012;7(10):e47636.
  • Gootz TD, Lescoe MK, Dib-Hajj F, et al. Genetic organization of transposase regions surrounding blaKPC carbapenemase genes on plasmids from Klebsiella strains isolated in a New York City hospital. Antimicrob Agents Chemother. 2009;53(5):1998–2004.
  • Chmelnitsky I, Hermesh O, Navon-Venezia S, et al. Detection of aac(6’)-Ib-cr in KPC-producing Klebsiella pneumoniae isolates from Tel Aviv, Israel. J Antimicrob Chemother. 2009;64(4):718–722.
  • Chen L, Chavda KD, Melano RG, et al. Molecular survey of the dissemination of two blaKPC-harboring IncFIA plasmids in New Jersey and New York hospitals. Antimicrob Agents Chemother. 2014;58(4):2289–2294.
  • Seni J, Falgenhauer L, Simeo N, et al. Multiple ESBL-producing Escherichia coli sequence types carrying quinolone and aminoglycoside resistance genes circulating in companion and domestic farm animals in Mwanza, Tanzania, harbor commonly occurring plasmids. Front Microbiol. 2016;7:142.
  • Burke L, Humphreys H, Fitzgerald-Hughes D. The molecular epidemiology of resistance in cefotaximase-producing Escherichia coli clinical isolates from Dublin, Ireland. Microb Drug Resist. 2016;22(7):552–558.
  • Castanheira M, Woosley LN, Doyle TB, et al. Aminoglycoside-resistance genes among 2014-2015 US carbapenem resistant Enterobacteriaceae isolates and activity of plazomicin against characterized isolates [Poster]. Presented at the 2017 American Society for Microbiology Microbe; 2017; New Orleans, LA.
  • Berçot B, Poirel L, Nordmann P. Updated multiplex polymerase chain reaction for detection of 16S rRNA methylases: high prevalence among NDM-1 producers. Diagn Microbiol Infect Dis. 2001;71(4):442–445.
  • Lioy VS, Goussard S, Guerineau V, et al. Aminoglycoside resistance 16S rRNA methyltransferases block endogenous methylation, affect translation efficiency and fitness of the host. RNA. 2014;20(3):382–391.
  • Zhanel GG, Lawson CD, Zelenitsky S, et al. Comparison of the next-generation aminoglycoside plazomicin to gentamicin, tobramycin and amikacin. Expert Rev Anti Infect Ther. 2012;10(4):459–473.
  • Galimand M, Sabtcheva S, Courvalin P, et al. World- wide disseminated armA aminoglycoside resistance methylase gene is borne by composite transposon Tn1548. Antimicrob Agents Chemother. 2005;49(7):2949–2953.
  • Tamma PD, Rodriguez-Bano J. The use of noncarbapenem ß-Lactams for the treatment of extended-spectrum ß-Lactamase infections. Clin Infect Dis. 2017;64(7):972–980.
  • Rodríguez-Baño J, Gutiérrez-Gutiérrez B, Machuca I, et al. Treatment of infections caused by extended-spectrum-beta-lactamase-, AmpC-, and carbapenemase-producing enterobacteriaceae. Clin Microbiol Rev. 2018;31(2):e00079–17.
  • Sheu CC, Chang YT, Lin SY, et al. Infections caused by carbapenem-resistant Enterobacteriaceae: an update on therapeutic options. Front Microbiol. 2019;10:80.
  • Zemdri (plazomicin) [package insert]. South San Francisco, CA: Achaogen Inc; 2018.
  • U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee. FDA briefing document: plazomicin sulfate injection (NDA 210303). [cited 2020 Jan 21]. Available from: https://www.fda.gov/media/113161/download.
  • National Center for Biotechnology Information. PubChem Database. Plazomicin, CID=42613186.[cited 2020 Jan 20]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Plazomicin.
  • Cox G, Ejim L, Stogios PJ, et al. Plazomicin retains antibiotic activity against most aminoglycoside modifying enzymes. ACS Infect Dis. 2018;4(6):980–987.
  • Center for Drug Evaluation and Research. Clinical microbiology/virology review(s) (NDA 210303). [cited 2020 Jan 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210303Orig1s000MicroR.pdf.
  • U.S. Food and Drug Administration. Plazomicin Injection - Interpretive Criteria. [cited 2019 Nov 25]. Available from: https://www.fda.gov/drugs/development-resources/plazomicin-injection.
  • The United States Committee on Antimicrobial Susceptibility Testing (USCAST). Breakpoint tables for interpretation of MIC and zone diameter results. Version 6.0; 2020.
  • Sander HS, Streit JM, Arends SJ, et al. Antimicrobial activity of plazomicin tested against a worldwide collection of Enterobacterales isolated from patients with complicated urinary tract infections (2014–2017) [Poster AAR-591]. Presented at the 2019 American Society for Microbiology Microbe. San Francisco, CA; 2019.
  • Castanheira M, Streit JM, Desphande LM, et al. Activity of plazomicin and comparator agents tested against recent clinical isolates collected in Asia-Pacific, Europe, and Latin America [Poster 1280]. Presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases. Vienna, Austria; 2017.
  • Taylor E, Sriskandan S, Woodford N, et al. High prevalence of 16S rRNA methyltransferases among carbapenemase-producing Enterobacteriaceae in the UK and Ireland. Int J Antimicrob Agents. 2018;52(2):278–282.
  • Achaogen, Inc. Plazomicin. Oral presentation at Antimicrobial Drugs Advisory Committee Meeting. South San Francisco, CA; 2018.
  • Serio AW, Keepers T, Krause KM. Plazomicin is active against metallo-ß-lactamase-producing Enterobacteriaceae. Open Forum Infect Dis. 2019;6(4):ofz123.
  • Zhanel GG, Adam HJ, Baxter M, et al. In vitro activity of plazomicin against gram-negative and gram-positive pathogens isolated from patients in Canadian hospitals in 2011-2015: CANWARD surveillance study [Poster]. Presented at the 2017 American Society for Microbiology Microbe. New Orleans, LA; 2017.
  • Walkty A, Adam H, Baxter M, et al. In vitro activity of plazomicin against 5,015 gram-negative and gram-positive clinical isolates obtained from patients in Canadian hospitals as part of the CANWARD study, 2011–2012. Antimicrob Agents Chemother. 2014;58(5):2554–2564.
  • Walkty A, Karlowsky JA, Baxter MR, et al. In vitro activity of plazomicin against gram-negative and gram-positive bacterial pathogens isolated from patients in Canadian hospitals from 2013 to 2017 as part of the CANWARD surveillance study. Antimicrob Agents Chemother. 2018;63(1):e02068–18.
  • Cass RT, Brooks CD, Havrilla NA, et al. Pharmacokinetics and safety of single and multiple doses of ACHN-490 injection administered intravenously in healthy subjects. Antimicrob Agents Chemother. 2011;55(12):5874–5880.
  • Riddle V, Cebrik KC, Ma L, et al. The pharmacokinetics and safety of plazomicin in subjects with renal impairment [Poster 918]. Presented at the 23rd European Congress of Clinical Microbiology and Infectious Diseases. Berlin, Germany; 2013.
  • Center for Drug Evaluation and Research. Approval Package for NDA 210303. [cited 2020 Apr 12. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210303Orig1s000Approv.pdf.
  • Cass R, Kostrub CF, Gotfried M, et al. A double- blind, randomized, placebo-controlled study to assess the safety, tolerability, plasma pharmacokinetics and lung penetration of intravenous plazomicin in healthy subjects [Poster 1637]. Presented at the 23rd European Congress of Clinical Microbiology and Infectious Diseases. Berlin, Germany; 2013.
  • Thwaites M, Hall D, Shinabarger D, et al. Evaluation of the bactericidal activity of plazomicin and comparators against multidrug-resistant Enterobacteriaceae. Antimicrob Agents Chemother. 2018;62(8):e00236–18.
  • Louie A, Kostrub CF, Fikes S, et al. Plazomicin demonstrates potent efficacy against carbapenem-resistant Enterobacteriaceae (CRE) in the neutropenic mouse thigh infection model [Poster 2961]. Presented at the 23rd European Congress of Clinical Microbiology and Infectious Diseases. Berlin, Germany; 2013.
  • Achaogen Inc. Antimicrobial Drugs Advisory Committee Meeting Briefing Book: plazomicin (NDA 210303). [cited 2020 Jan 21]. Available from: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM606040.pdf.
  • Van Wart SAFA, Drusano GL, Bhavnani SM, et al. Pharmacokinetic-pharmacodynamic analysis predicts a high probability of efficacy for plazomicin against serious infections caused by carbapenem-resistant Enterobacteriaceae [Poster 914]. Presented at the 23rd European Congress of Clinical Microbiology and Infectious Diseases. Berlin, Germany; 2013.
  • Thermo Fisher Scientific. QMS Plazomicin Immunoassay. [cited 2020 Feb 4]. Available from: https://www.thermofisher.com/us/en/home/clinical/diagnostic-testing/clinical-chemistry-drug-toxicology-testing/therapeutic-drug-monitoring/qms-plazomicin.html.
  • Asempa TE, Kuti JL, Seroogy JD, et al. Application of the Hartford Hospital nomogram for plazomicin dosing interval selection in patients with complicated urinary tract infection. Antimicrob Agents Chemother. 2019;63(10):e00148–19.
  • Asempa TE, Kuti JL, Seroogy JD, et al. A simulated application of the Hartford Hospital nomogram for plazomicin dosing interval selection in patients with serious infections caused by carbapenem-resistant Enterobacterales. Clin Ther. 2019;41(8):1453–1462.
  • Connolly LE, Riddle V, Cebrik D, et al. A multicenter, randomized, double-blind, phase 2 study of the efficacy and safety of plazomicin compared with levofloxacin in the treatment of complicated urinary tract infection and acute pyelonephritis. Antimicrob Agents Chemother. 2018;62(4):e01989–17.
  • Wagenlehner FME, Cloutier DJ, Komirenko AS, et al. Once-daily plazomicin for complicated urinary tract infections. N Engl J Med. 380(8): 729–740. 2019.
  • Mckinnell JA, Dwyer JP, Talbot GH, et al. Plazomicin for infections caused by carbapenem-resistant Enterobacteriaceae. N Engl J Med. 380(8): 791–793. 2019.
  • Gall J, Choi T, Riddle V, et al. A phase 1 study of intravenous plazomicin in healthy adults to assess potential effects on the QT/QTc interval, safety, and pharmacokinetics. Clin Pharmacol Drug Dev. 2019;8(8):1032–1041.
  • U.S. Food and Drug Administration. FDA adverse events reporting system public dashboard. [cited 2020 Jan 25]. Available from: https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/45beeb74-30ab-46be-8267-5756582633b4/state/analysis.
  • U.S. Food and Drug Administration. What is a serious adverse event? [cited 2020 Jan 25]. https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event.
  • GlobeNewswire News Room. Achaogen plans for near-term sale using structured process through chapter 11 of the U.S. bankruptcy code. 2019 Apr 15 [cited 2020 Feb 2]. Available from: https://www.globenewswire.com/news-release/2019/04/15/1803906/0/en/Achaogen-Plans-for-Near-Term-Sale-Using-Structured-Process-Through-Chapter-11-of-the-U-S-Bankruptcy-Code.html.
  • GlobeNewswire News Room. Achaogen, Inc. Announces results of auction for substantially all company assets. 2019 June 6 [cited 2020 Feb 2] Available from: https://www.globenewswire.com/news-release/2019/06/06/1865709/0/en/Achaogen-Inc-Announces-Results-of-Auction-for-Substantially-All-Company-Assets.html.
  • Achaogen, Inc. Ordering Information for ZEMDRI (plazomicin). [cited 2020 Feb 2]. Available from: https://zemdri.com/assets/pdf/Ordering-Distribution-Information.pdf.
  • Gilbert DN, Guidos RJ, Boucher HW, et al. The 10 x ‘20 Initiative: pursuing a global commitment to develop 10 new antibacterial drugs by 2020. Clin Infect Dis. 2010;50(8):1081–1083.
  • Bush K, Bradford PA. Interplay between ß-lactamases and new ß-lactamase inhibitors. Nat Rev Microbiol. 2019;17(5):295–306.
  • Mischnik A, Lübbert C, Mutters NT. New ß-lactam antibiotics and ß-lactamase inhibitors against multidrug-resistant gram-negative bacteria. Internist (Berl). 2018;59(12):1335–1343.
  • Heffernan AJ, Sime FB, Lipman J, et al. Intrapulmonary pharmacokinetics of antibiotics used to treat nosocomial pneumonia caused by gram-negative bacilli: a systematic review. Int J Antimicrob Agents. 2019;53(3):234–245.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.