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Drug Profile

Meropenem–vaborbactam for adults with complicated urinary tract and other invasive infections

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Pages 865-876 | Received 06 Aug 2018, Accepted 26 Oct 2018, Published online: 05 Nov 2018

References

  • Schappert SM, Rechtsteiner EA. Ambulatory medical care utilization estimates for 2007. Vital Health Stat. 2011;13(169):1–38.
  • Uçkay I, Sax H, Gayet-Ageron A, et al. High proportion of healthcare-associated urinary tract infection in the absence of prior exposure to urinary catheter: a cross-sectional study. Antimicrob Resist Infect Control. 2013;2(1):5.
  • Chenoweth CE, Gould CV, Saint S. Diagnosis, management, and prevention of catheter-associated urinary tract infections. Infect Dis Clin North Am. 2014;28(1):105–119.
  • Gupta K, Bhadelia N. Management of urinary tract infections from multidrug-resistant organisms. Infect Dis Clin North Am. 2014;28(1):49–59.
  • Calbo E, Romaní V, Xercavins M, et al. Risk factors for community-onset urinary tract infections due to Escherichia coli harbouring extended-spectrum beta-lactamases. J Antimicrob Chemother. 2006;57(4):780–783.
  • Zilberberg MD, Nathanson BH, Sulham K, et al. Carbapenem resistance, inappropriate empiric treatment and outcomes among patients hospitalized with Enterobacteriaceae urinary tract infection, pneumonia and sepsis. BMC Infect Dis. 2017;17(1):279.
  • Weiner LM, Webb AK, Limbago B, et al. Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2011–2014. Infect Control Hosp Epidemiol. 2016;37(11):1288–1301.
  • Alexander EL, Loutit J, Tumbarello M, et al. Carbapenem-resistant infections: results from a retrospective series and implications for the design of prospective clinical trials. Open Forum Infect Dis. 2017;4(2):ofx063.
  • Jacob JT, et al. Vital signs: carbapenem-resistant Enterobacteriaceae. MMWR Morb Mortal Wkly Rep. 2013;62(9):165–170.
  • Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States. 2013 [cited 2018 May 16] Available from: https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf
  • Meletis G. Carbapenem resistance: overview of the problem and future perspectives. Ther Adv Infect Dis. 2016;3((1):):15–21.
  • Munoz-Price LS, Poirel L, Bonomo RA, et al. Clinical epidemiology of the global expansion of Klebsiella pneumoniae carbapenemases. Lancet Infect Dis. 2013;13(9):785–796.
  • Leavitt A, Navon-Venezia S, Chmelnitsky I, et al. Emergence of KPC-2 and KPC-3 in carbapenem-resistant Klebsiella pneumoniae strains in an Israeli hospital. Antimicrob Agents Chemother. 2007;51(8):3026–3029.
  • Hoenigl M, Valentin T, Zarfel G, et al. Nosocomial outbreak of Klebsiella pneumoniae carbapenemase-producing Klebsiella oxytoca in Austria. Antimicrob Agents Chemother. 2012;56(4):2158–2161.
  • Rahman M, Shukla SK, Prasad KN, et al. Prevalence and molecular characterisation of New Delhi metallo-β-lactamases NDM-1, NDM-5, NDM-6 and NDM-7 in multidrug-resistant Enterobacteriaceae from India. Int J Antimicrob Agents. 2014;44(1):30–37.
  • Albiger B, Glasner C, Struelens M, et al.; the European Survey of Carbapenemase-Producing Enterobacteriaceae (EuSCAPE) working group. Carbapenemase-producing Enterobacteriaceae in Europe: assessment by national experts in 38 countries. Euro Surveill. 2015;20(45).
  • Nordmann P, Naas T, Poirel L. Global spread of carbapenemase-producing Enterobacteriaceae. Emerg Infect Dis. 2011;17(10):1791–1798.
  • Alexander BT, Marschall J, Tibbetts RJ, et al. Treatment and clinical outcomes of urinary tract infections caused by KPC-producing Enterobacteriaceae in a retrospective cohort. Clin Ther. 2012;34(6):1314–1323.
  • Satlin MJ, Kubin CJ, Blumenthal JS, et al. Comparative effectiveness of aminoglycosides, polymyxin B, and tigecycline for clearance of carbapenem-resistant Klebsiella pneumoniae from urine. Antimicrob Agents Chemother. 2011;55(12):5893–5899.
  • Zarkotou O, Pournaras S, Tselioti P, et al. Predictors of mortality in patients with bloodstream infections caused by KPC-producing Klebsiella pneumoniae and impact of appropriate antimicrobial treatment. Clin Microbiol Infect. 2011;17:1798–1803.
  • Qureshi ZA, Paterson DL, Potoski BA, et al. Treatment outcome of bacteremia due to KPC-producing Klebsiella pneumoniae: superiority of combination antimicrobial regimens. Antimicrob Agents Chemother. 2012;56:2108–2113.
  • Daikos GL, Tsaousi S, Tzouvelekis LS, et al. Carbapenemase-producing Klebsiella pneumoniae bloodstream infections: lowering mortality by antibiotic combination schemes and the role of carbapenems. Antimicrob Agents Chemother. 2014;58(4):2322–2328.
  • Tumbarello M, Viale P, Viscoli C, et al. Predictors of mortality in bloodstream infections caused by Klebsiella pneumoniae carbapenemase-producing K pneumoniae: importance of combination therapy. Clin Infect Dis. 2012;55:943–950.
  • Tumbarello M, Trecarichi EM, De Rosa FG, et al. Infections caused by KPC-producing Klebsiella pneumoniae: differences in therapy and mortality in a multicentre study. J Antimicrob Chemother. 2015;70(7):2133–2143.
  • Pogue JM, Ortwine JK, Kaye KS. Are there any ways around the exposure-limiting nephrotoxicity of the polymyxins? Int J Antimicrob Agents. 2016;48(6):622–626.
  • Yu H, Qu F, Shan B, et al. Detection of the mcr-1 colistin resistance gene in carbapenem-resistant Enterobacteriaceae from different hospitals in China. Antimicrob Agents Chemother. 2016;60(8):5033–5035.
  • Castanheira M, Mills JC, Costello SE, et al. Ceftazidime-avibactam activity tested against Enterobacteriaceae isolates from U.S. Hospitals (2011–2013) and characterization of B-lactamase producing strains. Antimicrob Agents Chemother. 2015;59:3509–3517.
  • Aktaş Z, Kayacan C, Oncul O. In vitro activity of avibactam (NXL104) in combination with β-lactams against gram-negative bacteria, including OXA-48 β-lactamase-producing Klebsiella pneumoniae. Int J Antimicrob Agents. 2012;39:86–89.
  • Wang X, Zhang F, Zhao C, et al. In vitro activities of ceftazidime-avibactam and aztreonam-avibactam against 372 gram-negative bacilli collected in 2011 and 2012 from 11 teaching hospitals in China. Antimicrob Agents Chemother. 2014;58:1774–1778.
  • Shields RK, Nguyen MH, Chen L, et al. Ceftazidime-avibactam is superior to other treatment regimens against carbapenem-resistant Klebsiella pneumoniae bacteremia. Antimicrob Agents Chemother. 2017;61:pii: e00883-17.
  • van Duin D, Lok JJ, Earley M, et al. Colistin versus ceftazidime-avibactam in the treatment of infections due to carbapenem-resistant Enterobacteriaceae. Clin Infect Dis. 2018;66:163–171.
  • Humphries RM, Yang S, Hemarajata P, et al. First report of ceftazidime-avibactam resistance in a KPC-3-expressing Klebsiella pneumoniae isolate. Antimicrob Agents Chemother. 2015;59(10):6605–6607.
  • Livermore DM, Warner M, Jamrozy D, et al. In vitro selection of ceftazidime-avibactam resistance in Enterobacteriaceae with KPC-3 carbapenemase. Antimicrob Agents Chemother. 2015;59(9):5324–5330.
  • Shields RK, Potoski BA, Haidar G, et al. Clinical outcomes, drug toxicity, and emergence of ceftazidime-avibactam resistance among patients treated for carbapenem-resistant Enterobacteriaceae infections. Clin Infect Dis. 2016;63:1615–1618.
  • Mouton JW, van Den Anker JN. Meropenem clinical pharmacokinetics. Clin Pharmacokinet. 1995;28:275–286.
  • Meropenem-vaborbactam [package insert]. Parsippany (NJ): The Medicines Company; 2017.
  • Pfaller MA, Huband MD, Mendes RE, et al. In vitro activity of meropenem/vaborbactam and characterisation of carbapenem resistance mechanisms among carbapenem-resistant Enterobacteriaceae from the 2015 meropenem/vaborbactam surveillance programme. Int J Antimicrob Agents. 2018 Aug;52(2):144-150.
  • Hackel MA, Lomovskaya O, Dudley MN, et al. Activity of meropenem-vaborbactam against clinical isolates of KPC-positive Enterobacteriaceae. Antimicrob Agents Chemother. 2017;21(62):pii: e01904-17.
  • Lomovskaya O, Sun D, Rubio-Aparicio D, et al. Vaborbactam: spectrum of beta-lactamase inhibition and impact of resistance mechanisms on activity in Enterobacteriaceae. Antimicrob Agents Chemother. 2017;24(61):pii: e01443-17.
  • Castanheira M, Huband MD, Mendes RE, et al. Meropenem-vaborbactam tested against contemporary gram-negative isolates collected worldwide during 2014, including carbapenem-resistant, KPC-producing, multidrug-resistant, and extensively drug-resistant Enterobacteriaceae. Antimicrob Agents Chemother. 2017;61:9.
  • Fish DN, Singletary TJ. Meropenem, a new carbapenem antibiotic. Pharmacotherapy. 1997;17(4):644–669.
  • Livermore DM. Multiple mechanisms of antimicrobial resistance in Pseudomonas aeruginosa: our worst nightmare? Clin Infect Dis. 2002;34(5):634–640.
  • Poirel L, Nordmann P. Carbapenem resistance in Acinetobacter baumannii: mechanisms and epidemiology. Clin Microbiol Infect. 2006;12(9):826–836.
  • Pfaller MA, Huband MD, Mendes RE, et al. In vitro activity of meropenem-vaborbactam and characterization of carbapenem resistance mechanisms among carbapenem-resistant Enterobacteriaceae from the 2015 meropenem-vaborbactam surveillance program. Int J Antimicrob Agents. 2018 Aug;52(2):144-150.
  • Sabet M, Tarazi Z, Rubio-Aparicio D, et al. Activity of simulated human dosage regimens of meropenem and vaborbactam against carbapenem-resistant Enterobacteriaceae in an hollow-fiber model. Antimicrob Agents Chemother. 2018;62(2) e01969-17.
  • Sun D, Rubio-Aparicio D, Nelson K, et al. Meropenem-vaborbactam resistance selection, resistance prevention, and molecular mechanisms in mutants of KPC-producing Klebsiella pneumoniae. Antimicrob Agents Chemother. 2017;61(12).
  • Griffith DC, Loutit JS, Morgan EE, et al. Phase 1 study of the safety, tolerability, and pharmacokinetics of the β-Lactamase inhibitor vaborbactam (RPX7009) in healthy adult subjects Antimicrob Agents Chemother. 2016;60(10):6326–6332.
  • Meropenem [package insert]. Wilmington (DE): AstraZeneca; 2006.
  • Rubino CM, Bhavnani SM, Loutit JS, et al. 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. Antimicrob Agents Chemother. 2018 Mar 27;62(4):pii: e02228-17.
  • Wenzler E, Gotfried MH, Loutit JS, et al. Meropenem-RPX7009 concentrations in plasma, epithelial lining fluid, and alveolar macrophages of healthy adult subjects. Antimicrob Agents Chemother. 2015;59(12):7232–7239.
  • Trang MGD, Bhavnani SM, Loutit JS, et al. Population pharmacokinetics of meropenem and vaborbactam in healthy volunteers and infected patients. 2nd ASM Microbe; 2017 Jun 1-5; New Orleans (LA).
  • Bhavnani SMHJ, Rubino CMB, Tran J, et al. Meropenem–vaborbactam pharmacokinetic pharmacodynamic analyses for efficacy based on data from patients enrolled in phase 3 studies. 2nd ASM Microbe; 2017 June 1-5; New Orleans (LA).
  • Rubino CM, Bhavnani SM, Loutit JS, et al. Meropenem-vaborbactam: single-dose pharmacokinetics and safety in subjects with chronic renal impairment.. Antimicrob Agents Chemother. 2018 Feb 23;62(3) e02103-17.
  • Nicolau DP. Pharmacokinetic and pharmacodynamic properties of meropenem. Clin Infect Dis. 2008;15(47 Suppl 1):S32–S40.
  • Griffith DC, Sabet M, Tarazi Z, et al. Pharmacodynamics of vaborbactam when administered in combination with meropenem. Presented at: 2nd ASM Microbe; Jun 1-5; New Orleans (LA); 2017.
  • Kaye KS, Bhowmick T, Metallidis S, et al. 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. JAMA. 2018;319(8):788–799. This study was approved by local institutional review board.
  • US Food and Drug Administration Guidance for Industry. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases: guidance for industry. FDA. 2017 Aug [cited 2018 May 27] Available from: https://www.fda.gov/downloads/Drugs/Guidances/UCM359184.pdf
  • Wunderink RG, Giamarellos-Bourboulis EJ, Rahav G, et al. Effect and Safety of Meropenem-Vaborbactam versus Best-Available Therapy in Patients with Carbapenem-Resistant Enterobacteriaceae Infections: The TANGO II Randomized Clinical Trial. Infect Dis Ther. 2018 Oct 1 [ePublication ahead of print].
  • Lomovskaya O, Castanheira M, Vazquez J, et al. Assessment of MIC increases with meropenem-vaborbactam and ceftaizdime-avibactam in Tango II (a phase 3 study of the treatment of CRE infections. Presented at ID week; San Diego, CA; 2017 27. [abstract 1874].
  • Miller AD, Ball AM, Bookstaver PB, et al. Epileptogenic potential of carbapenem agents: mechanism of action, seizure rates, and clinical considerations. Pharmacotherapy. 2011;31:408–423.
  • Mohi H, Takahasi K, Mitzuni T. Interaction between valproic acid and carbapenem antibiotics. Drug Metab Rev. 2007;39:647–657.
  • Frumin J, Gallagher JC. Allergic cross-sensitivity between penicillin, carbapenem, and monobactam antibiotics: what are the chances? Ann Pharmacother. 2009;43:304–315.
  • Romano A, Viola M, Gueant-Rodriguez RM, et al. Brief communication: tolerability of meropenem in patients with IgE-mediated hypersensitivity to penicillins. Ann Intern Med. 2007;146:266–269.
  • [cited 2018 May 8] Available from: https://www.nasdaq.com/press-release/melinta-therapeutics-announces-vabomere-meropenem-and-vaborbactam-granted-new-technology-addon-20180803-00688
  • Lucasti C, Vasile L, Sandesc D, et al. Phase 2, dose-ranging study of relebactam with imipenem-cilastatin in subjects with complicated intra-abdominal infection. Antimicrob Agents Chemother. 2016;60(10):6234–6243.
  • Sims M, Mariyanovski V, McLeroth P, et al. Prospective, randomized, double-blind, phase 2 dose-ranging study comparing efficacy and safety of imipenem/cilastatin plus relebactam with imipenem/cilastatin alone in patients with complicated urinary tract infections. J Antimicrob Chemother. 2017;72(9):2616–2626.
  • Motsch J, Stus V, Koksal I. RESTORE-IMI 1: a multicenter, randomized, double-blind, comparator-controlled trial comparing the efficacy and safety of imipenem/relebactam versus colistin plus imipenem in patients with imipenem-non-susceptible bacterial infections. European congress of clinical microbiology and infectious diseases; Madrid; 2018 Apr 21-24.
  • Portsmouth S, Van Veenhuyzen D, Echols R, et al. Clinical response of cefiderocol compared with imipenem/cilastatin in the treatment of adults with complicated urinary tract infectious with or without pyelonephritis or acute uncomplicated pyelonephritis: results from a multicenter, double-blind, randomized study. Open Forum Infect Dis. 2017;4:S537–S528.
  • McKinnell JACL, Pushkin R, Jubb AM, et al. Improved outcomes with plazomicin compared with colistin in patients with bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (CRE): results from the CARE study. Poster 1853 IDWeek; San Diego (CA); 2017.
  • Cloutier DJKA, Cebrik DS, Keepers TR, et al. Plazomicin versus meropenem for complicated urinary tract infection and acute pyelonephritis: diagnosis-specific results from the phase 3 EPIC study. Poster 1855.IDWeek; San Diego (CA).
  • Kaye KS, Rice LB, Dane A, et al. Intravenous fosfomycin (ZTI-01) for the treatment of complicated urinary tract infections (cUTI) including acute pyelonephritis (AP): results from a multi-center, randomized, double-blind phase 2/3 study in hospitalized adults (ZEUS). Presented at: IDWeek; 2017 Oct 4-8; San Diego (CA); Poster 1845.
  • Solomkin J, Evans D, Slepavicius A, et al. Assessing the efficacy and safety of eravacycline vs ertapenem in complicated intra-abdominal infections in the investigating gram-negative infections treated with eravacycline (IGNITE 1) trial: a randomized clinical trial. JAMA Surg. 2016;152:224–232.
  • Tetraphase announces top-line results from IGNITE2 phase 3 clinical trial of eravacycline in cUTI. Available from: http://ir.tphase.com/releasedetail.cfm?releaseid=930613. Accessed 10 October 2018.

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