Plazomicin: An investigational therapy for the treatment of urinary tract infections

Expert Opinion on Investigational Drugs

Volumn 24, Issue 11, 2015, Pages 1501-1511

  Karaiskos, Ilias ^a   Souli, Maria ^b   Giamarellou, Helen ^a  

^a IASO GENERAL HOSPITAL   (Greece)

^b NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

Author keywords

ACHN 490; acute pyelonephritis; aminoglycoside; multidrug resistant; novel antibiotics; plazomicin; urinary tract infections

Indexed keywords

PLAZOMICIN; 6'-(HYDROXYLETHYL)-1-(HABA)-SISOMICIN; ANTIINFECTIVE AGENT; SISOMICIN;

ACUTE PYELONEPHRITIS; AREA UNDER THE CURVE; ARTICLE; BLURRED VISION; CLINICAL STUDY; DIZZINESS; DRUG EFFICACY; DRUG HALF LIFE; DRUG INFORMATION; DRUG INTERACTION; DRUG MECHANISM; DRUG METABOLISM; EPICONDYLITIS; HUMAN; HYPESTHESIA; IN VITRO STUDY; MAXIMUM PLASMA CONCENTRATION; MINIMUM PLASMA CONCENTRATION; MULTICENTER STUDY (TOPIC); NAUSEA; NEPHROTOXICITY; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); SEVERE RENAL IMPAIRMENT; SOMNOLENCE; TINNITUS; URINARY TRACT INFECTION; ACUTE DISEASE; ANALOGS AND DERIVATIVES; ANIMAL; IMMUNOLOGY; MICROBIOLOGY; MULTIDRUG RESISTANCE; PYELONEPHRITIS; URINARY TRACT INFECTIONS;

ACUTE DISEASE; ANIMALS; ANTI-BACTERIAL AGENTS; DRUG RESISTANCE, MULTIPLE, BACTERIAL; HUMANS; PYELONEPHRITIS; SISOMICIN; URINARY TRACT INFECTIONS;

EID: 84946710112     PISSN: 13543784     EISSN: 17447658     Source Type: Journal    
DOI: 10.1517/13543784.2015.1095180     Document Type: Article

References (46)

1. Magiorakos AP, Srinivasan A, Carey RB, et al. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect 2012; 18: 268-81
2. Boucher HW, Talbot GH, Bradley JS, et al. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis 2009; 48: 1-12
3. Tzouvelekis LS, Markogiannakis A, Psichogiou M, et al. Carbapenemases in Klebsiella pneumoniae and other Enterobacteriaceae: an evolving crisis of global dimensions. Clin Microbiol Rev 2012; 25: 682-707
4. Karaiskos I, Giamarellou H. Multidrug-resistant and extensively drug-resistant Gram-negative pathogens: current and emerging therapeutic approaches. Expert Opin Pharmacother 2014; 15: 1351-70
5. Aggen JB, Armstrong ES, Goldblum AA, et al. Synthesis and spectrum of the neoglycoside ACHN-490. Antimicrob Agents Chemother 2010; 54: 4636-42
6. Jana S, Deb J K. Molecular understanding of aminoglycoside action and resistance. Appl Microbiol Biotechnol 2006; 70: 140-50
7. Wachino J, Arakawa Y. Exogenously acquired 16S rRNA methyltransferases found in aminoglycoside-resistant pathogenic Gram-negative bacteria: An update. Drug Res Updates 2012; 15: 133-48
8. Galani I, Moraitou E, Orlandou K, et al. Prevalence of 16S rRNA methylase genes in Enterobacterial isolates in two Greek hospitals in a three year period Abstract P1010. 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); 10-13 May 2014; Barcelona, Spain
9. Doi Y, Arakawa Y. 16S ribosomal RNA methylation: emerging resistance mechanism against aminoglycosides. Clin Infect Dis 2007; 45: 88-94
10. Galani I, Souli M, Panagea T, et al. Prevalence of 16S rRNA methylase genes in enterobacteriaceae isolates from a greek University Hospital. Clin Microbiol Infect 2012; 18: E52-4
11. Livermore DM, Mushtaq S, Warner M, et al. Activity of aminoglycosides, including ACHN-490, against carbapenem-resistant Enterobacteriaceae isolates. J Antimicrob Chemother 2011; 66: 48-53
12. Livermore DM. Multiple mechanisms of antimicrobial resistance in Pseudomonas aeruginosa: our worst nightmare? Clin Infect Dis 2002; 34: 634-40
13. Poole K. Efflux-mediated antimicrobial resistance. J Antimicrob Chemother 2005; 56: 20-51
14. Armstrong ES, Miller GH. Combating evolution with intelligent design: the neoglycoside ACHN-490. Curr Opin Microbiol 2010; 13: 565-73
15. Franklin K, Clarke AJ. Overexpression and characterization of the chromosomal Aminoglycoside 29-N-acetyltransferase of Providencia stuartii. Antimicrob Agents Chemother 2001; 45: 2238-44
16. Almaghrabi R, Clancy CJ, Doi Y, et al. Carbapenem-resistant Klebsiella pneumoniae strains exhibit diversity in aminoglycoside-modifying enzymes, which exert differing effects on plazomicin and other agents. Antimicrob Agents Chemother 2014; 58: 4443-51
17. Galani I, Souli M, Daikos GL, et al. Activity of plazomicin (ACHN-490) against MDR clinical isolates of Klebsiella pneumoniae, Escherichia coli, and Enterobacter spp. from Athens, Greece. J Chemother 2012; 24: 191-4
18. Endimiani A, Hujer KM, Hujer AM, et al. ACHN-490, a neoglycoside with potent in vitro activity against multidrug-resistant Klebsiella pneumoniae isolates. Antimicrob Agents Chemother 2009; 53: 4504-7
19. 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: 2554-63
20. Landman D, Kelly P, Backer M, et al. Antimicrobial activity of a novel aminoglycoside, ACHN-490, against Acinetobacter baumannii and Pseudomonas aeruginosa from New York City. J Antimicrob Chemother 2011; 66: 332-4
21. Heine HS, Miller L, Halasohoris S, et al. Activity and efficacy of ACHN-490, a broad-spectrum next generation aminoglycoside, against Yersinia pestis and Francisella tularensis Abstract 210. 48th Infectious Diseases Society of America (IDSA) Annual Meeting; 21-24 October 2010; Vancouver, BC
22. Olsen SC, Carlson SA. In vitro bactericidal activity of aminoglycosides, including the next-generation drug plazomicin, against Brucella spp. Int J Antimicrob Agents 2015; 45: 76-8
23. Tenover FC, Tickler I, Armstrong ES, et al. Activity of ACHN-490 against methicillin-resistant Staphylococcus aureus (MRSA) isolates from patients in US hospitals. Int J Antimicrob Agents 2011; 38: 352-4
24. Lin G, Ednie LM, Appelbaum PC. Antistaphylococcal activity of ACHN-490 tested alone and in combination with other agents by time-kill assay. Antimicrob Agents Chemother 2010; 54: 2258-61
25. Zurenko G, Stapert D, Knechtel M, et al. The bactericidal activity of the neoglycoside ACHN-490 against aminoglycoside-resistant bacteria Abstract F1-841. 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 12-15 September 2009; San Francisco, CA
26. Pankuch GA, Lin G, Kubo A, et al. Activity of ACHN-490 tested alone and in combination with other agents against Pseudomonas aeruginosa. Antimicrob Agents Chemother 2011; 55: 2463-5
27. Pillar CM, Stoneburner A, Serio AW. Plazomicin is potent alone and in combination with other broad-spectrum agents, with no antagonism, against KPC producing Klebsiella pneumoniae Abstract E-1168B. 53th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 10-13 September 2013; Denver, CO
28. 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): 5874-80
29. Van Wart SA, Bhavnani SM, Forrest A, et al. Population Pharmacokinetics of ACHN-490 Injection in Healthy Subjects Abstract 209. 48th Annual Meeting of Infectious Diseases Society of America (IDSA); 21-24 October 2010; Vancouver
30. Van Wart SA, Forrest A, Drusano GL, et al. Pharmacokinetic-pharmacodynamics (PK-PD) predict a high probability of efficacy for plazomicin against serious infections caused by carbapenem-resistant Enterobacteriaceae (CRE) Abstract P-914. 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); 27-30 April 2013; Berlin
31. VanWart SA, Forrest A, Bulik CC, et al. Pharmacokinetic/Pharmacodynamic (PK/PD) Assessment Predicts High Efficacy for Plazomicin Against Serious Infections Caused by Carbapenem-Resistant Klebsiella pneumoniae (CR Kp) Abstract A-1054c. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 10-13 September 2013; Denver
32. 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): 459-73
33. Riddle VD, Cebrik D, Kostrub C, et al. The pharmacokinetics (PK) and safety of plazomicin in subjects with renal impairment Abstract P-918. 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); 27-30 April 2013; Berlin
34. 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 Abstract P-1637. 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); 27-30 April 2013; Berlin
35. Dull WL, Alexander MR, Kasik JE. Bronchial secretion levels of amikacin. Antimicrob Agents Chemother 1979; 16 (6): 767-71
36. Galani I. Plazomicin. Aminoglycoside antibiotic. Drugs Future 2014; 39 (1): 25-35
37. Riddle V, Mason J, Cebrik D, et al. The Effect of Plazomicin Injection on the QT/QTc Interval in Healthy Volunteers Abst A-017f. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 10-13 September 2013; Denver
38. Riddle V, Cebrik D, Armstrong E, et al. Plazomicin Safety and Efficacy in Patients with Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Abstract L2-2118a. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 9-12 September 2012; San Francisco
39. Connolly L, Serio A, Riddle V, et al. Baseline Pathogens and Patient Outcomes in a Phase 2 Study Comparing Plazomicin (ACHN-490) to Levofloxacin in Complicated Urinary Tract Infection (cUTI) including Acute Pyelonephritis (AP) presentation O200. 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); 25-28 April 2015; Copehhagen
40. Vidal L, Gafter-Gvili A, Borok S, et al. Efficacy and safety of aminoglycoside monotherapy: systematic review and meta-analysis of randomized controlled trials. J Antimicrob Chemother 2007; 60 (2): 247-57
41. A study of plazomicin compared with colistin in patients with infection due to carbapenem-resistant enterobacteriaceae (CRE). ClinicalTrials.gov Identifier: NCT01970371. Available from: www.clinicaltrials.gov [. [Last accessed August 2015]
42. A study of plazomicin compared with meropenem for the treatment of complicated urinary tract infection (cUTI) including acute pyelonephritis (AP). ClinicalTrials.gov Identifier: NCT02486627. Available from: www.clinicaltrials.gov [. Last accessed June 2015]
43. Kostrub C, Dolan D, Altschuler R, et al. Ototoxic potential of ACHN-490 compared to gentamicin and amikacin in the quinea pig Abstract P-1249. 20th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); 10-13 April 2010; Vienna
44. Poulikakos P, Falagas ME. Aminoglycoside therapy in infectious diseases. Expert Opin Pharmacother 2013; 14 (12): 1585-97
45. Badal R, Lob S, Mackel M, et al. In vitro activity of ACHN-490 against recent respiratory tract pathogens Abstract E-131. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 17-20 September 2011; Chicago, IL
46. Landman D, Babu E, Shah N, et al. Activity of a novel aminoglycoside, ACHN-490, against clinical isolates of Escherichia coli and Klebsiella pneumoniae from New York City. J Antimicrob Chemother 2010; 65: 2123-7