Ceftolozane/Tazobactam: A Novel Cephalosporin/β-Lactamase Inhibitor Combination

Pharmacotherapy

Volumn 35, Issue 7, 2015, Pages 701-715

  Cho, Jonathan C ^a   Fiorenza, Mallory A ^a   Estrada, Sandy J ^a  

^a Lee Memorial Health System   (United States)

Author keywords

ceftolozane tazobactam; cephalosporin; CXA 101; CXA 201; FR264205; gram negative bacteria

Indexed keywords

CEFTOLOZANE; CEPHALOSPORIN; TAZOBACTAM; ANTIINFECTIVE AGENT; BETA LACTAMASE INHIBITOR; CEFTOLOZANE, TAZOBACTAM DRUG COMBINATION; CEPHALOSPORIN DERIVATIVE; PENICILLANIC ACID;

ABDOMINAL PAIN; ANTIBIOTIC RESISTANCE; ANTIBIOTIC SENSITIVITY; AREA UNDER THE CURVE; BACTERIAL STRAIN; BACTERICIDAL ACTIVITY; BIOLOGICAL MODEL; CLINICAL EFFECTIVENESS; CONSTIPATION; DIARRHEA; DOSE RESPONSE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDICATION; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; DRUG TOLERABILITY; ENTEROBACTER; ESCHERICHIA COLI; ESCHERICHIA COLI INFECTION; FEVER; HEADACHE; HUMAN; HYPOGLYCEMIA; IN VITRO STUDY; KLEBSIELLA OXYTOCA; KLEBSIELLA PNEUMONIAE; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; NAUSEA; NONHUMAN; PARESTHESIA; PROTEUS MIRABILIS; PRURITUS; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; RECOMMENDED DRUG DOSE; REVIEW; SOMNOLENCE; STRUCTURE ACTIVITY RELATION; VULVOVAGINAL DISEASE; ANAEROBIC BACTERIUM; ANALOGS AND DERIVATIVES; ANIMAL; CHEMISTRY; DRUG EFFECTS; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; MICROBIAL SENSITIVITY TEST; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANIMALS; ANTI-BACTERIAL AGENTS; BACTERIA, ANAEROBIC; BETA-LACTAMASE INHIBITORS; CEPHALOSPORINS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG RESISTANCE, BACTERIAL; GRAM-NEGATIVE BACTERIA; GRAM-POSITIVE BACTERIA; HUMANS; MICROBIAL SENSITIVITY TESTS; PENICILLANIC ACID; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84937515119     PISSN: 02770008     EISSN: 18759114     Source Type: Journal    
DOI: 10.1002/phar.1609     Document Type: Review

References (49)

1. Spellberg B, Blaser M, Guidos RJ, et al., Combating antimicrobial resistance: policy recommendations to save lives. Clin Infect Dis 2011; 52: S397-428.
2. Roberts RR, Hota B, Ahmad I, et al., Hospital and societal costs of antimicrobial-resistant infections in a Chicago teaching hospital: implications for antibiotic stewardship. Clin Infect Dis 2009; 49: 1175-84.
3. Talbot GH, Bradley J, Edwards JE Jr, Gilbert D, Scheld M, Bartlett JG,. Bad bugs need drugs: an update on the development pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America. Clin Infect Dis 2006; 42: 657-68.
4. Spellberg B, Guidos R, Gilbert D, et al., The epidemic of antibiotic resistant infections: a call to action for the medical community from the Infectious Diseases Society of America. Clin Infect Dis 2008; 46: 155-64.
5. Centers for Disease Control and Prevention. Antibiotic threats in the United States, 2013. Available from http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf. Accessed January 21, 2015.
6. Rice LB,. Progress and challenges in implementing the research on ESKAPE pathogens. Infect Control Hosp Epidemiol 2010; 31: S7-10.
7. Boucher HW, Talbot GH, Benjamin DK Jr, et al., 10 x '20 progress-development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America. Clin Infect Dis 2013; 56: 1685-94.
8. Stein GE,. Antimicrobial resistance in the hospital setting: impact, trends, and infection control measures. Pharmacotherapy 2005; 25: 44S-54S.
9. Mauldin PD, Salgado CD, Hansen IS, Durup DT, Bosso JA,. Attributable hospital cost and length of stay associated with health care-associated infections caused by antibiotic-resistant gram-negative bacteria. Antimicrob Agents Chemother 2010; 54: 109-15.
10. Mesaros N, Nordmann P, Plésiat P, et al., Pseudomonas aeruginosa: resistance and therapeutic options at the turn of the new millennium. Clin Microbiol Infect 2007; 13: 560-78.
11. Giamarellou H, Antoniadou A,. Antipseudomonal antibiotics. Med Clin North Am 2001; 85: 19-42.
12. Snydman DR, McDermott LA, Jacobus NV,. Activity of ceftolozane-tazobactam against a broad spectrum of recent clinical anaerobic isolates. Antimicrob Agents Chemother 2014; 58: 1218-23.
13. Sader HS, Rhomberg PR, Farrell DJ, Jones RN,. Antimicrobial activity of CXA-101, a novel cephalosporin tested in combination with tazobactam against Enterobacteriaceae, Pseudomonas aeruginosa, and Bacteroides fragilis strains having various resistance phenotypes. Antimicrob Agents Chemother 2011; 55: 2390-4.
14. Farrell DJ, Flamm RK, Sader HS, Jones RN,. Antimicrobial activity of ceftolozane/tazobactam tested against Enterobacteriaceae and Pseudomonas aeruginosa with various resistance patterns isolated in U.S. hospitals (2011-2012). Antimicrob Agents Chemother 2013; 57: 6305-10.
15. Wagenlehner F, Umeh O, Huntington J, et al., Efficacy and safety of ceftolozane/tazobactam versus levofloxacin in the treatment of complicated urinary tract infections (cUTI)/pyelonephritis in hospitalized adults: results from the phase 3 ASPECT cUTI trial [Poster eP449]. Presented at: European congress of clinical microbiology and infectious diseases (ECCMID). Barcelona, Spain, May 10-13, 2014.
16. Solomkin J, Hershberger E, Miller B, et al., Ceftolozane/tazobactam plus metronidazole for complicated intra-abdominal infections in an era of multidrug resistance: results from a randomized, double-blind, phase 3 trial (ASPECT-cIAI). Clin Infect Dis 2015; 60 (10): 1462-71.
17. U.S. National Institutes of Health. ClinicalTrials.gov. Available from https://clinicaltrials.gov/ct2/show/NCT02070757?term=ceftolozane%2Ftazobactam&rank=1. Accessed January 13, 2015.
18. Toda A, Ohki H, Yamanaka T, et al., Synthesis and SAR of novel parenteral anti-pseudomonal cephalosporins: discovery of FR264205. Bioorg Med Chem Lett 2008; 18: 4849-52.
19. Murano K, Ymanaka T, Toda A, et al., Structural requirements for the stability of novel cephalosporins to AmpC beta-lactamase based on 3D-structure. Bioorg Med Chem 2008; 16: 2261-75.
20. Cubist Pharmaceuticals U.S. Zerbaxa (ceftolozane/tazobactam) package insert. Lexington, MA, 2014.
21. Moya B, Zamorano L, Juan C, Perez JL, Ge Y, Oliver A,. Activity of a new cephalosporin, CXA-101 (FR264205), against β-lactam-resistant Pseudomonas aeruginosa mutants selected in vitro and after antipseudomonal treatment of intensive care unit patients. Antimicrob Agents Chemother 2010; 54: 1213-7.
22. Moya B, Beceiro A, Cabot G, et al., Pan-β-lactam resistance development in Pseudomonas aeruginosa clinical strains: molecular mechanisms, penicillin-binding protein profiles, and binding affinities. Antimicrob Agents Chemother 2012; 56: 4771-8.
23. Clinical and Laboratory Standards Institute (CLSI). Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard-ninth edition. CLSI document M07-A9, Wayne, PA: Clinical and Laboratory Standards Institute, 2012.
24. Clinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibility testing; twenty-fourth informational supplement. CLSI document M100-S24. Wayne, PA: Clinical and Laboratory Standards Institute, 2014.
25. Takeda S, Nakai T, Wakai Y, Ikeda F, Hatano K,. In vitro and in vivo activities of a new cephalosporin, FR264205, against Pseudomonas aeruginosa. Antimicrob Agents Chemother 2007; 51: 826-30.
26. Cabot G, Mulet X, Moya B, et al., Dynamics and mechanisms of resistance development to ceftazidime, meropenem and ceftolozane/tazobactam in wild-type and mutator P. aeruginosa strains. 52nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2012). San Francisco, CA, September 9-12, 2012. Poster C1-1970.
27. Livermore DM, Mushtaq S, Ge Y,. Chequerboard titration of cephalosporin CXA-101 and tazobactam versus beta-lactamase-producing Enterobacteriaceae. J Antimicrob Chemother 2010; 65: 1972-4.
28. Castanheira M, Mills JC, Farrell DJ, Jones RN,. Mutation-driven β-lactam resistance mechanisms among contemporary ceftazidime-nonsusceptible Pseudomonas aeruginosa isolates from U.S. hospitals. Antimicrob Agents Chemother 2014; 58: 6844-50.
29. Zamorano L, Juan C, Fernandez-Olmos A, Ge Y, Canton R, Oliver A,. Activity of the new cephalosporin CXA-101 (FR264205) against Pseudomonas aeruginosa isolates from chronically-infected cystic fibrosis patients. Clin Microbiol Infect 2010; 16: 1482-7.
30. Ge Y, Whitehouse MJ, Friedland I, Talbot GH,. Pharmacokinetics and safety of CXA-101, a new antipseudomonal cephalosporin, in healthy adult male and female subjects receiving single- and multiple-dose intravenous infusions. Antimicrob Agents Chemother 2010; 54: 3427-31.
31. Miller B, Hershberger E, Benziger D, Trinh M, Friedland I,. Pharmacokinetics and safety of intravenous ceftolozane-tazobactam in health adult subjects following single and multiple ascending doses. Antimicrob Agents Chemother 2012; 56: 3086-91.
32. Wise R, Logan M, Cooper M, Andrews JM,. Pharmacokinetics and tissue penetration of tazobactam administered alone and with piperacillin. Antimicrob Agents Chemother 1991; 35: 1081-4.
33. Miller B, Chandorkar G, Umeh O, et al., Safety and pharmacokinetics (PK) of intravenous (IV) ceftolozane/tazobactam (C/T) 3 g every 8 hours (q8 h) and cumulative fraction of response (CFR) in plasma and epithelial lining fluid (ELF) in a simulated ventilator-associated pneumonia (VAP) population [abstract no. A-641 plus poster]. 52nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, September 9-12, 2012.
34. Miller B, Hershberger E, Benziger D, et al., Pharmacokinetics of CXA-101/tazobactam in subjects with mild or moderate renal impairment [abstract no. P1519]. Clin Microbiol Infect 2011; 17 (Suppl.4): S433. Plus poster presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases; Milan, May 7-10, 2011.
35. Wooley M, Miller B, Krishna G, Hershberger E, Chandorkar G,. Impact of renal function on the pharmacokinetics and safety of ceftolozane-tazobactam. Antimicrob Agents Chemother 2014; 58: 2249-55.
36. Ge Y, Liao S,. CXA-101 (CXA) population PK analysis and Monte Carlo (MC) Simulation for PK/PD target attainment and dose regimen selection [abstract no. F1-2003 plus poster]. 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, September 12-15, 2009.
37. Chandorkar G, Xiao A, Mouksassi MS, Hershberger E, Krishna G,. Population pharmacokinetics of ceftolozane/tazobactam in healthy volunteers, subjects with varying degrees of renal function and patients with bacterial infections. J Clin Pharmacol 2015; 55: 230-9.
38. Marier JF, Trinh M, Pheng LH, et al., Population PK analysis of intravenous CXA-101 in subjects with complicated urinary tract infection, including pyelonephritis [abstract no. PII-49 plus poster]. 112th annual meeting of the American Society for Clinical Pharmacology and Therapeutics. Dallas, March 2-5, 2011.
39. Chandorkar G, Huntington JA, Gotfried MH, Rodvold KA, Umeh O,. Intrapulmonary penetration of ceftolozane/tazobactam and piperacillin/tazobactam in healthy adult subjects. J Antimicrob Chemother 2012; 67: 2463-9.
40. Bulik CC, Tessier PR, Keel RA, Sutherland CA, Nicolau DP,. In vivo comparison of CXA-101 (FR264205) with and without tazobactam versus piperacillin-tazobactam using human simulated exposures against phenotypically diverse gram-negative organisms. Antimicrob Agents Chemother 2012; 56: 544-9.
41. Craig WA, Andes DR,. In vivo activities of ceftolozane, a new cephalosporin, with and without tazobactam against Pseudomonas aeruginosa and Enterobacteriaceae, including strains with extended-spectrum β-lactamases, in the thighs of neutropenic mice. Antimicrob Agents Chemother 2013; 57: 1577-82.
42. Hershberger E, Mouksassi M, Steenbergen JN, et al., CXA-101/tazobactam probability of target attainment using population pharmacokinetic analysis. Presented at 21st European Congress of Clinical Microbiology and Infectious Diseases and Twenty-seventh International Congress of Chemotherapy. Milan, Italy, May 7-10, 2011.
43. Jacqueline C, Roquilly A, Desessard C, et al., Efficacy of ceftolozane in a murine model of Pseudomonas aeruginosa acute pneumonia: in vivo antimicrobial activity and impact on host inflammatory response. J Antimicrob Chemother 2013; 68: 177-83.
44. Bretonnière C, Boutoille D, Caillon J, et al., In vivo efficacy of ceftolozane against Pseudomonas aeruginosa in a rabbit experimental model of pneumonia: comparison with ceftazidime, piperacillin/tazobactam and imipenem. Int J Antimicrob Agents 2014; 44: 218-21.
45. Jacqueline C, Desessard C, Roquilly A, et al., 50% effective dose (ED50) determination of CXA-101 (CXA) alone or in combination with tazobactam (TAZ) for treating experimental peritonitis in mice due to extended-spectrum ß-lactamase (ESBL)-producing Escherichia coli (EC) strains: comparison with ceftazidime (CAZ) and piperacillin/tazobactam (TZP) [abstract no. F1-2000 plus poster]. 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, September 12-15, 2009.
46. Jacqueline C, Desessard C, Batard E, et al., ED50 determination of CXA-101 (CXA) alone and in combination with tazobactam (TAZ) for treating experimental peritonitis in mice due to ESBL producing Klebsiella pneumoniae strains: comparison with ceftazidime (CAZ) and piperacillin/tazobactam (TZP) [abstract no. B-708 plus poster]. 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Boston, September 12-15, 2010.
47. Lucasti C, Hershberger E, Miller B, et al., Multicenter, double-blind, randomized, Phase II trial to assess the safety and efficacy of ceftolozane-tazobactam plus metronidazole compared with meropenem in adult patients with complicated intra-abdominal infections. Antimicrob Agents Chemother 2014; 58: 5350-7.
48. U.S. National Institutes of Health. ClinicalTrials.gov. Available from https://clinicaltrials.gov/ct2/show/NCT02266706?term=ceftolozane%2Ftazobactam&rank=3. Accessed January 14, 2015
49. Umeh O, Cebrik D, Friedland I,. A double-blind, randomized, phase 2 study to compare the safety and efficacy of intravenous CXA-101 (CXA) and intravenous ceftazidime (CTZ) in complicated urinary tract infection (cUTI) [abstract no. L1-361A plus poster]. 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Boston, September 12-15, 2010.