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Volumn 58, Issue 9, 2014, Pages 5350-5357

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

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CEFTOLOZANE; GAMMA GLUTAMYLTRANSFERASE; MEROPENEM; METRONIDAZOLE; TAZOBACTAM; CEFTOLOZANE, TAZOBACTAM DRUG COMBINATION; CEPHALOSPORIN DERIVATIVE; PENICILLANIC ACID; THIENAMYCIN DERIVATIVE;

EID: 84906085321     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00049-14     Document Type: Article
Times cited : (96)

References (31)
  • 2
    • 85027920728 scopus 로고    scopus 로고
    • Trends in susceptibility of selected Gram-negative bacilli isolated from intra-abdominal infections in North America: SMART 2005-2010
    • Babinchak T, Badal R, Hoban D, Hackel M, Hawser S, Lob S, Bouchillon S. 2013. Trends in susceptibility of selected Gram-negative bacilli isolated from intra-abdominal infections in North America: SMART 2005-2010. Diagn. Microbiol. Infect. Dis. 76:379-381. http://dx.doi.org/10.1016/j.diagmicrobio.2013.02.031.
    • (2013) Diagn. Microbiol. Infect. Dis. , vol.76 , pp. 379-381
    • Babinchak, T.1    Badal, R.2    Hoban, D.3    Hackel, M.4    Hawser, S.5    Lob, S.6    Bouchillon, S.7
  • 3
    • 70449124604 scopus 로고    scopus 로고
    • Antibacterial-resistant Pseudomonas aeruginosa: Clinical impact and complex regulation of chromosomally encoded resistance mechanisms
    • Lister PD, Wolter DJ, Hanson ND. 2009. Antibacterial-resistant Pseudomonas aeruginosa: clinical impact and complex regulation of chromosomally encoded resistance mechanisms. Clin. Microbiol. Rev. 22:582-610. http://dx.doi.org/10.1128/CMR.00040-09.
    • (2009) Clin. Microbiol. Rev. , vol.22 , pp. 582-610
    • Lister, P.D.1    Wolter, D.J.2    Hanson, N.D.3
  • 4
    • 0034763241 scopus 로고    scopus 로고
    • Extended-spectrum β-lactamases in the 21st century: Characterization, epidemiology, and detection of this important resistance threat
    • DOI 10.1128/CMR.14.4.933-951.2001
    • Bradford PA. 2001. Extended-spectrum β-lactamases in the 21st century: characterization, epidemiology, and detection of this important resistance threat. Clin. Microbiol. Rev. 14:933-951. http://dx.doi.org/10.1128/ CMR.14.4.933-951.2001. (Pubitemid 32979636)
    • (2001) Clinical Microbiology Reviews , vol.14 , Issue.4 , pp. 933-951
    • Bradford, P.A.1
  • 5
    • 78751572709 scopus 로고    scopus 로고
    • Antimicrobial susceptibility of intra-abdominal Gram-negative bacilli from Europe: SMART Europe 2008
    • Hawser S, Hoban D, Bouchillon S, Badal R, Carmeli Y, Hawkey P. 2011. Antimicrobial susceptibility of intra-abdominal Gram-negative bacilli from Europe: SMART Europe 2008. Eur. J. Clin. Microbiol. Infect. Dis. 30:173-179. http://dx.doi.org/10.1007/s10096-010-1066-0.
    • (2011) Eur. J. Clin. Microbiol. Infect. Dis. , vol.30 , pp. 173-179
    • Hawser, S.1    Hoban, D.2    Bouchillon, S.3    Badal, R.4    Carmeli, Y.5    Hawkey, P.6
  • 6
    • 79960325246 scopus 로고    scopus 로고
    • Susceptibility of Klebsiella pneumoniae isolates from intra-abdominal infections and molecular characterization of ertapenem-resistant isolates
    • Hawser SP, Bouchillon SK, Lascols C, Hackel M, Hoban DJ, Badal RE, Woodford N, Livermore DM. 2011. Susceptibility of Klebsiella pneumoniae isolates from intra-abdominal infections and molecular characterization of ertapenem-resistant isolates. Antimicrob. Agents Chemother. 55:3917-3921. http://dx.doi.org/10.1128/AAC.00070-11.
    • (2011) Antimicrob. Agents Chemother. , vol.55 , pp. 3917-3921
    • Hawser, S.P.1    Bouchillon, S.K.2    Lascols, C.3    Hackel, M.4    Hoban, D.J.5    Badal, R.E.6    Woodford, N.7    Livermore, D.M.8
  • 8
    • 84888857844 scopus 로고    scopus 로고
    • Susceptibility of Gram-negative aerobic bacilli from intra-abdominal pathogens to antimicrobial agents collected in the United States during 2011
    • Hawser SP, Badal RE, Bouchillon SK, Hoban DJ, Hackel MA, Biedenbach DJ, Goff DA. 2014. Susceptibility of Gram-negative aerobic bacilli from intra-abdominal pathogens to antimicrobial agents collected in the United States during 2011. J. Infect. 68:71-76. http://dx.doi.org/10.1016/j.jinf.2013.09.001.
    • (2014) J. Infect. , vol.68 , pp. 71-76
    • Hawser, S.P.1    Badal, R.E.2    Bouchillon, S.K.3    Hoban, D.J.4    Hackel, M.A.5    Biedenbach, D.J.6    Goff, D.A.7
  • 9
    • 79955536362 scopus 로고    scopus 로고
    • 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
    • Sader HS, Rhomberg PR, Farrell DJ, Jones RN. 2011. 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. 55:2390-2394. http://dx.doi.org/10.1128/AAC.01737-10.
    • (2011) Antimicrob. Agents Chemother. , vol.55 , pp. 2390-2394
    • Sader, H.S.1    Rhomberg, P.R.2    Farrell, D.J.3    Jones, R.N.4
  • 10
    • 79955005040 scopus 로고    scopus 로고
    • In vitro activity of CXA-101 plus tazobactam (CXA-201) against CTX-M-14- and CTX-M-15-producing Escherichia coli and Klebsiella pneumoniae
    • Titelman E, Karlsson IM, Ge Y, Giske CG. 2011. In vitro activity of CXA-101 plus tazobactam (CXA-201) against CTX-M-14- and CTX-M-15-producing Escherichia coli and Klebsiella pneumoniae. Diagn. Microbiol. Infect. Dis. 70:137-141. http://dx.doi.org/10.1016/j.diagmicrobio.2011.02.004.
    • (2011) Diagn. Microbiol. Infect. Dis. , vol.70 , pp. 137-141
    • Titelman, E.1    Karlsson, I.M.2    Ge, Y.3    Giske, C.G.4
  • 11
    • 77955618992 scopus 로고    scopus 로고
    • Chequerboard titration of cephalosporin CXA-101 (FR264205) and tazobactam versus β-lactamase-producing Enterobacteriaceae
    • Livermore DM, Mushtaq S, Ge Y. 2010. Chequerboard titration of cephalosporin CXA-101 (FR264205) and tazobactam versus β-lactamase- producing Enterobacteriaceae. J. Antimicrob. Chemother. 65:1972-1974. http://dx.doi.org/10.1093/jac/dkq248.
    • (2010) J. Antimicrob. Chemother. , vol.65 , pp. 1972-1974
    • Livermore, D.M.1    Mushtaq, S.2    Ge, Y.3
  • 12
    • 84887449664 scopus 로고    scopus 로고
    • Antimicrobial activity of ceftolozane/tazobactam tested against Enterobacteriaceae and Pseudomonas aeruginosa with various resistance patterns isolated in U.S. hospitals (2011-2012)
    • Farrell DJ, Flamm RK, Sader HS, Jones RN. 2013. 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. 57:6305-6310. http://dx.doi.org/10. 1128/AAC.01802-13.
    • (2013) Antimicrob. Agents Chemother. , vol.57 , pp. 6305-6310
    • Farrell, D.J.1    Flamm, R.K.2    Sader, H.S.3    Jones, R.N.4
  • 13
    • 84885898863 scopus 로고    scopus 로고
    • In vitro activity of ceftolozane-tazobactam against Pseudomonas aeruginosa isolates obtained from patients in Canadian hospitals in the CANWARD study, 2007 to 2012
    • Walkty A, Karlowsky JA, Adam H, Baxter M, Lagace-Wiens P, Hoban DJ, Zhanel GG. 2013. In vitro activity of ceftolozane-tazobactam against Pseudomonas aeruginosa isolates obtained from patients in Canadian hospitals in the CANWARD study, 2007 to 2012. Antimicrob. Agents Chemother. 57:5707-5709. http://dx.doi.org/10.1128/AAC.01404-13.
    • (2013) Antimicrob. Agents Chemother. , vol.57 , pp. 5707-5709
    • Walkty, A.1    Karlowsky, J.A.2    Adam, H.3    Baxter, M.4    Lagace-Wiens, P.5    Hoban, D.J.6    Zhanel, G.G.7
  • 14
    • 77149179342 scopus 로고    scopus 로고
    • 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
    • Moya B, Zamorano L, Juan C, Perez JL, Ge Y, Oliver A. 2010. 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. 54:1213-1217. http://dx.doi.org/10.1128/AAC.01104-09.
    • (2010) Antimicrob. Agents Chemother. , vol.54 , pp. 1213-1217
    • Moya, B.1    Zamorano, L.2    Juan, C.3    Perez, J.L.4    Ge, Y.5    Oliver, A.6
  • 15
    • 34848844055 scopus 로고    scopus 로고
    • Stability of FR264205 against AmpC β-lactamase of Pseudomonas aeruginosa
    • DOI 10.1016/j.ijantimicag.2007.05.019, PII S0924857907002658
    • Takeda S, Ishii Y, Hatano K, Tateda K, Yamaguchi K. 2007. Stability of FR264205 against AmpC β-lactamase of Pseudomonas aeruginosa. Int. J. Antimicrob. Agents 30:443-445. http://dx.doi.org/10.1016/j.ijantimicag.2007.05. 019. (Pubitemid 47498958)
    • (2007) International Journal of Antimicrobial Agents , vol.30 , Issue.5 , pp. 443-445
    • Takeda, S.1    Ishii, Y.2    Hatano, K.3    Tateda, K.4    Yamaguchi, K.5
  • 16
    • 84875175772 scopus 로고    scopus 로고
    • 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
    • Craig WA, Andes DR. 2013. 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. 57:1577-1582. http://dx.doi.org/10.1128/AAC.01590-12.
    • (2013) Antimicrob. Agents Chemother. , vol.57 , pp. 1577-1582
    • Craig, W.A.1    Andes, D.R.2
  • 17
    • 84893465570 scopus 로고    scopus 로고
    • Activity of ceftolozane-tazobactam against a broad spectrum of recent clinical anaerobic isolates
    • Snydman DR, McDermott LA, Jacobus NV. 2014. Activity of ceftolozane-tazobactam against a broad spectrum of recent clinical anaerobic isolates. Antimicrob. Agents Chemother. 58:1218-1223. http://dx.doi.org/10.1128/ AAC.02253-13.
    • (2014) Antimicrob. Agents Chemother. , vol.58 , pp. 1218-1223
    • Snydman, D.R.1    McDermott, L.A.2    Jacobus, N.V.3
  • 18
    • 84906080431 scopus 로고    scopus 로고
    • A multicenter, double-blind, randomized, phase 2 study to assess the safety and efficacy of ceftolozane/tazobactam (TOL/ TAZ) plus metronidazole (MTZ) compared to meropenem (MER) in adult patients with complicated intra-abdominal infections (cIAI), poster K-1709
    • Lucasti C, Hershberger E, Miller B, Yankelev S, Steenbergen J, Friedland I, Solomkin. 2013. A multicenter, double-blind, randomized, phase 2 study to assess the safety and efficacy of ceftolozane/tazobactam (TOL/ TAZ) plus metronidazole (MTZ) compared to meropenem (MER) in adult patients with complicated intra-abdominal infections (cIAI), poster K-1709. 53rd Annu. Intersci. Conf. Antimicrob. Agents Chemother., 10-13 September 2013, Denver, CO.
    • (2013) 53rd Annu. Intersci. Conf. Antimicrob. Agents Chemother., 10-13 September 2013, Denver, CO
    • Lucasti, C.1    Hershberger, E.2    Miller, B.3    Yankelev, S.4    Steenbergen, J.5    Friedland, I.6    Solomkin7
  • 19
    • 84906086585 scopus 로고    scopus 로고
    • AstraZeneca Pharmaceuticals LP, Wilmington, DE
    • AstraZeneca Pharmaceuticals. 2013. Merrem i.v. prescribing information. AstraZeneca Pharmaceuticals LP, Wilmington, DE. http://www1.astrazeneca-us.com/ pi/merremiv.pdf.
    • (2013) Merrem I.V. Prescribing Information
  • 20
    • 84861121314 scopus 로고    scopus 로고
    • Pharmacokinetics and safety of intravenous ceftolozane-tazobactam in healthy adult subjects following single and multiple ascending doses
    • Miller B, Hershberger E, Benziger D, Trinh M, Friedland I. 2012. Pharmacokinetics and safety of intravenous ceftolozane-tazobactam in healthy adult subjects following single and multiple ascending doses. Antimicrob. Agents Chemother. 56:3086-3091. http://dx.doi.org/10.1128/AAC.06349-11.
    • (2012) Antimicrob. Agents Chemother. , vol.56 , pp. 3086-3091
    • Miller, B.1    Hershberger, E.2    Benziger, D.3    Trinh, M.4    Friedland, I.5
  • 23
    • 0001072895 scopus 로고
    • The use of confidence or fiducial limits illustrated in the case of the binomial
    • Clopper CJ, Pearson ES. 1934. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26:404-413. http://dx.doi.org/10.1093/biomet/26.4.404.
    • (1934) Biometrika , vol.26 , pp. 404-413
    • Clopper, C.J.1    Pearson, E.S.2
  • 24
    • 44849104852 scopus 로고    scopus 로고
    • Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: A phase III, prospective, multicenter, randomized, double-blind, noninferiority study
    • DOI 10.1016/j.clinthera.2008.04.019, PII S0149291808001690
    • Lucasti C, Jasovich A, Umeh O, Jiang J, Kaniga K, Friedland I. 2008. Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, noninferiority study. Clin. Ther. 30:868-883. http://dx.doi.org/10.1016/j.clinthera.2008.04.019. (Pubitemid 351799866)
    • (2008) Clinical Therapeutics , vol.30 , Issue.5 , pp. 868-883
    • Lucasti, C.1    Jasovich, A.2    Umeh, O.3    Jiang, J.4    Kaniga, K.5    Friedland, I.6
  • 25
    • 84877123198 scopus 로고    scopus 로고
    • Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: Results of a randomized, double-blind, phase II trial
    • Lucasti C, Popescu I, Ramesh MK, Lipka J, Sable C. 2013. Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, phase II trial. J. Antimicrob. Chemother. 68:1183-1192. http://dx.doi.org/10.1093/jac/dks523.
    • (2013) J. Antimicrob. Chemother. , vol.68 , pp. 1183-1192
    • Lucasti, C.1    Popescu, I.2    Ramesh, M.K.3    Lipka, J.4    Sable, C.5
  • 26
    • 84859625873 scopus 로고    scopus 로고
    • Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: Results from a randomized, controlled trial
    • Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. 2012. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg. Infect. (Larchmt.) 13:102-109. http://dx.doi.org/10.1089/sur.2011.048.
    • (2012) Surg. Infect. (Larchmt.) , vol.13 , pp. 102-109
    • Qvist, N.1    Warren, B.2    Leister-Tebbe, H.3    Zito, E.T.4    Pedersen, R.5    McGovern, P.C.6    Babinchak, T.7
  • 27
    • 84872897846 scopus 로고    scopus 로고
    • Monitoring the global in vitro activity of ertapenem against Escherichia coli from intra-abdominal infections: SMART 2002-2010
    • Hawser SP, Badal RE, Bouchillon SK, Hoban DJ, Biedenbach DJ, Canton R, Paterson DL. 2013. Monitoring the global in vitro activity of ertapenem against Escherichia coli from intra-abdominal infections: SMART 2002-2010. Int. J. Antimicrob. Agents. 41:224-228. http://dx.doi.org/10.1016/j.ijantimicag.2012.10. 014.
    • (2013) Int. J. Antimicrob. Agents. , vol.41 , pp. 224-228
    • Hawser, S.P.1    Badal, R.E.2    Bouchillon, S.K.3    Hoban, D.J.4    Biedenbach, D.J.5    Canton, R.6    Paterson, D.L.7
  • 28
    • 84555204766 scopus 로고    scopus 로고
    • Beta-lactam/beta-lactam inhibitor combinations for the treatment of bacteremia due to extended-spectrum beta-lactamase-producing Escherichia coli: A post hoc analysis of prospective cohorts
    • Rodriguez-Bano J, Navarro MD, Retamar P, Picon E, Pascual A. 2012. Beta-lactam/beta-lactam inhibitor combinations for the treatment of bacteremia due to extended-spectrum beta-lactamase-producing Escherichia coli: a post hoc analysis of prospective cohorts. Clin. Infect. Dis. 54:167-174. http://dx.doi.org/10.1093/cid/cir790.
    • (2012) Clin. Infect. Dis. , vol.54 , pp. 167-174
    • Rodriguez-Bano, J.1    Navarro, M.D.2    Retamar, P.3    Picon, E.4    Pascual, A.5
  • 29
    • 27144490073 scopus 로고    scopus 로고
    • Extended-spectrum beta-lactamases: A clinical update
    • Paterson DL, Bonomo RA. 2005. Extended-spectrum beta-lactamases: a clinical update. Clin. Microbiol. Rev. 18:657-686. http://dx.doi.org/10.1128/ CMR.18.4.657-686.2005.
    • (2005) Clin. Microbiol. Rev. , vol.18 , pp. 657-686
    • Paterson, D.L.1    Bonomo, R.A.2
  • 30
    • 23844486729 scopus 로고    scopus 로고
    • The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: Analysis of pooled clinical trial data
    • DOI 10.1086/431676
    • Babinchak T, Ellis-Grosse E, Dartois N, Rose GM, Loh E. 2005. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data. Clin. Infect. Dis. 41(Suppl 5):S354-S367. http://dx.doi.org/10.1086/431676. (Pubitemid 41170382)
    • (2005) Clinical Infectious Diseases , vol.41 , Issue.5 SUPPL.
    • Babinchak, T.1    Ellis-Grosse, E.2    Dartois, N.3    Rose, G.M.4    Loh, E.5


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