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1. Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with e coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance

Author

Harris, P. N. A., Tambyah, P. A., Lye, D. C., Mo, Y., Lee, T. H., Yilmaz, M., Alenazi, T. H., Arabi, Y., Falcone, M., Bassetti, M., Righi, E., Rogers, B. A., Kanj, S., Bhally, H., Iredell, J., Mendelson, M., Boyles, T. H., Looke, D., Miyakis, S., Walls, G., Al Khamis, M., Zikri, A., Crowe, A., Ingram, P., Daneman, N., Griffin, P., Athan, E., Lorenc, P., Baker, P., Roberts, L., Beatson, S. A., Peleg, A. Y., Harris-Brown, T., Paterson, D. L., Mcnamara, J., Sieler, R., Garlick, J., Costa, J., Roney, J., Pratt, N., Tabaja, H., Kmeid, J., Tayyar, R., El Zein, S., Jones, S., Cowan, R., Tai, A., Lin, B., Rad, B., Macmorran, E., Pollard, J., Dinleyici, R., Istanbullu, A., Ceylan, B., Mert, A., Hashhoush, M., Dalwi, T., Korman, T., Azzam, R., Birrell, M., Hughes, C., Khan, S., Lau, J., Lee, L., Lim, K., Lin, Y. D., Lister, D., New, D., Rafiei, N., Stewart, J., Trad, M. A., Aye Yeung, V., Mcbride, S., Holland, D., Hopkins, C., Luey, C., Taylor, S., Morpeth, S., Finney, M., Martin, M., Holland, U., Ali, J., Jureen, R., Underwood, N., Henderson, A., Runnegar, N., Slavin, M., Robinson, O., Rishu, A., Shawkat, S., Fish, J., Chin Liew, K., Newton, P., Merelli, M., Carnelutti, A., Ussai, S., Pecori, D., Izharuddin, E., Young, B., Ding, Y., Ram, R., Kelly, J., Joshi, N., Richards, G., Smith, O., Alli, A., Vermeulen, I., Wright, B., Grey, C., Stewart, A., Reddy, D., Wasserman, S., Richi, H., Sultana, K., Alanazi, N., Bin Awad, E., Franzetti, F., Stolz, A., De Kock, E., Magongoa, T., Dutoit, M., Russo, A., Dentone, C., Eisen, D., and Heyer, L.

Subjects
Adult, Male, Piperacillin, Tazobactam Drug Combination, Ceftriaxone, Drug Resistance, Bacterial, Penicillanic Acid, Bacteremia, Meropenem, Middle Aged, Anti-Bacterial Agents, Klebsiella Infections, Klebsiella pneumoniae, Cause of Death, Escherichia coli, Humans, Female, Thienamycins, Aged, Drug Resistance, Bacterial, Escherichia coli Infections, Piperacillin, Tazobactam Drug Combination
Published
2018

2. Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance

Author

Harris, P.N.A., Tambyah, P.A., Lye, D.C., Mo, Y., Lee, T.H., Yilmaz, M., Alenazi, T.H., Arabi, Y., Falcone, M., Bassetti, M., Righi, E., Rogers, B.A., Kanj, S., Bhally, H., Iredell, J., Mendelson, M., Boyles, T.H., Looke, D., Miyakis, S., Walls, G., Al Khamis, M., Zikri, A., Crowe, A., Ingram, P., Daneman, N., Griffin, P., Athan, E., Lorenc, P., Baker, P., Roberts, L., Beatson, S.A., Peleg, A.Y., Harris-Brown, T., Paterson, D.L., Robinson, J.O., Harris, P.N.A., Tambyah, P.A., Lye, D.C., Mo, Y., Lee, T.H., Yilmaz, M., Alenazi, T.H., Arabi, Y., Falcone, M., Bassetti, M., Righi, E., Rogers, B.A., Kanj, S., Bhally, H., Iredell, J., Mendelson, M., Boyles, T.H., Looke, D., Miyakis, S., Walls, G., Al Khamis, M., Zikri, A., Crowe, A., Ingram, P., Daneman, N., Griffin, P., Athan, E., Lorenc, P., Baker, P., Roberts, L., Beatson, S.A., Peleg, A.Y., Harris-Brown, T., Paterson, D.L., and Robinson, J.O.

Abstract

Importance: Extended-spectrum β-lactamases mediate resistance to third-generation cephalosporins (eg, ceftriaxone) in Escherichia coli and Klebsiella pneumoniae. Significant infections caused by these strains are usually treated with carbapenems, potentially selecting for carbapenem resistance. Piperacillin-tazobactam may be an effective “carbapenem-sparing” option to treat extended-spectrum β-lactamase producers. Objectives: To determine whether definitive therapy with piperacillin-tazobactam is noninferior to meropenem (a carbapenem) in patients with bloodstream infection caused by ceftriaxone-nonsusceptible E coli or K pneumoniae. Design, Setting, and Participants: Noninferiority, parallel group, randomized clinical trial included hospitalized patients enrolled from 26 sites in 9 countries from February 2014 to July 2017. Adult patients were eligible if they had at least 1 positive blood culture with E coli or Klebsiella spp testing nonsusceptible to ceftriaxone but susceptible to piperacillin-tazobactam. Of 1646 patients screened, 391 were included in the study. Interventions: Patients were randomly assigned 1:1 to intravenous piperacillin-tazobactam, 4.5 g, every 6 hours (n = 188 participants) or meropenem, 1 g, every 8 hours (n = 191 participants) for a minimum of 4 days, up to a maximum of 14 days, with the total duration determined by the treating clinician. Main Outcomes and Measures: The primary outcome was all-cause mortality at 30 days after randomization. A noninferiority margin of 5% was used. Results: Among 379 patients (mean age, 66.5 years; 47.8% women) who were randomized appropriately, received at least 1 dose of study drug, and were included in the primary analysis population, 378 (99.7%) completed the trial and were assessed for the primary outcome. A total of 23 of 187 patients (12.3%) randomized to piperacillin-tazobactam met the primary outcome of mortality at 30 days compared with 7 of 191 (3.7%) randomized to meropenem (risk difference, 8.6

Published
2018

3. Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with e coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance.

Author

Pollard J., Arabi Y., Athan E., Lorenc P., Baker P., Roberts L., Beatson S.A., Peleg A.Y., Harris-Brown T., Paterson D.L., McNamara J., Sieler R., Garlick J., Costa J., Roney J., Pratt N., Tabaja H., Kmeid J., Tayyar R., El Zein S., Jones S., Cowan R., Lin B., Rad B., MacMorran E., Dinleyici R., Istanbullu A., Ceylan B., Mert A., Hashhoush M., Dalwi T., Korman T., Azzam R., Birrell M., Hughes C., Khan S., Lau J., Lee L., Lim K., Lin Y.D., Lister D., New D., Rafiei N., Stewart J., Tai A., Trad M.A., Aye Yeung V., McBride S., Holland D., Hopkins C., Luey C., Taylor S., Morpeth S., Finney M., Martin M., Holland U., Ali J., Jureen R., Underwood N., Henderson A., Runnegar N., Slavin M., Robinson O., Rishu A., Shawkat S., Fish J., Chin Liew K., Newton P., Merelli M., Carnelutti A., Ussai S., Pecori D., Izharuddin E., Young B., Ding Y., Ram R., Kelly J., Joshi N., Richards G., Smith O., Alli A., Vermeulen I., Wright B., Grey C., Stewart A., Reddy D., Wasserman S., Richi H., Sultana K., Alanazi N., Bin Awad E., Franzetti F., Stolz A., De Kock E., Magongoa T., Dutoit M., Russo A., Dentone C., Eisen D., Heyer L., Harris P.N.A., Tambyah P.A., Lye D.C., Mo Y., Lee T.H., Yilmaz M., Alenazi T.H., Falcone M., Bassetti M., Righi E., Rogers B.A., Kanj S., Bhally H., Iredell J., Mendelson M., Boyles T.H., Looke D., Miyakis S., Walls G., Al Khamis M., Zikri A., Crowe A., Ingram P., Daneman N., Griffin P., Pollard J., Arabi Y., Athan E., Lorenc P., Baker P., Roberts L., Beatson S.A., Peleg A.Y., Harris-Brown T., Paterson D.L., McNamara J., Sieler R., Garlick J., Costa J., Roney J., Pratt N., Tabaja H., Kmeid J., Tayyar R., El Zein S., Jones S., Cowan R., Lin B., Rad B., MacMorran E., Dinleyici R., Istanbullu A., Ceylan B., Mert A., Hashhoush M., Dalwi T., Korman T., Azzam R., Birrell M., Hughes C., Khan S., Lau J., Lee L., Lim K., Lin Y.D., Lister D., New D., Rafiei N., Stewart J., Tai A., Trad M.A., Aye Yeung V., McBride S., Holland D., Hopkins C., Luey C., Taylor S., Morpeth S., Finney M., Martin M., Holland U., Ali J., Jureen R., Underwood N., Henderson A., Runnegar N., Slavin M., Robinson O., Rishu A., Shawkat S., Fish J., Chin Liew K., Newton P., Merelli M., Carnelutti A., Ussai S., Pecori D., Izharuddin E., Young B., Ding Y., Ram R., Kelly J., Joshi N., Richards G., Smith O., Alli A., Vermeulen I., Wright B., Grey C., Stewart A., Reddy D., Wasserman S., Richi H., Sultana K., Alanazi N., Bin Awad E., Franzetti F., Stolz A., De Kock E., Magongoa T., Dutoit M., Russo A., Dentone C., Eisen D., Heyer L., Harris P.N.A., Tambyah P.A., Lye D.C., Mo Y., Lee T.H., Yilmaz M., Alenazi T.H., Falcone M., Bassetti M., Righi E., Rogers B.A., Kanj S., Bhally H., Iredell J., Mendelson M., Boyles T.H., Looke D., Miyakis S., Walls G., Al Khamis M., Zikri A., Crowe A., Ingram P., Daneman N., and Griffin P.

Abstract

IMPORTANCE Extended-spectrum beta-lactamases mediate resistance to third-generation cephalosporins (eg, ceftriaxone) in Escherichia coli and Klebsiella pneumoniae. Significant infections caused by these strains are usually treated with carbapenems, potentially selecting for carbapenem resistance. Piperacillin-tazobactam may be an effective "carbapenem-sparing" option to treat extended-spectrum beta-lactamase producers. OBJECTIVES To determine whether definitive therapy with piperacillin-tazobactam is noninferior to meropenem (a carbapenem) in patients with bloodstream infection caused by ceftriaxone-nonsusceptible E coli or K pneumoniae. DESIGN, SETTING, AND PARTICIPANTS Noninferiority, parallel group, randomized clinical trial included hospitalized patients enrolled from 26 sites in 9 countries from February 2014 to July 2017. Adult patients were eligible if they had at least 1 positive blood culture with E coli or Klebsiella spp testing nonsusceptible to ceftriaxone but susceptible to piperacillin-tazobactam. Of 1646 patients screened, 391 were included in the study. INTERVENTIONS Patients were randomly assigned 1:1 to intravenous piperacillin-tazobactam, 4.5 g, every 6 hours (n = 188 participants) or meropenem, 1 g, every 8 hours (n = 191 participants) for a minimum of 4 days, up to a maximum of 14 days, with the total duration determined by the treating clinician. MAIN OUTCOMES AND MEASURES The primary outcome was all-cause mortality at 30 days after randomization. A noninferiority margin of 5% was used. RESULTS Among 379 patients (mean age, 66.5 years; 47.8% women) who were randomized appropriately, received at least 1 dose of study drug, and were included in the primary analysis population, 378 (99.7%) completed the trial and were assessed for the primary outcome. A total of 23 of 187 patients (12.3%) randomized to piperacillin-tazobactam met the primary outcome of mortality at 30 days compared with 7 of 191 (3.7%) randomized to meropenem (risk difference, 8.6

Published
2018

11. Carbapenem-Resistant Enterobacteriaceae: A Retrospective Review of Presentation, Treatment, and Clinical Outcomes in a Tertiary Care Referral Hospital.

Author

Al Khamis M, AlMusa Z, Hashhoush M, Alsaif N, Salam A, and Atta M

Abstract

Background: Carbapenem-resistant Enterobacteriaceae (CRE) is an emerging infectious threat with an increasing incidence locally and worldwide. It carries a high morbidity and mortality; focusing on this topic should be a priority in clinical research as local data are not widely available. The objective of this study is to describe the presentation, risk factors, treatment pattern and clinical outcomes associated with CRE infections., Methods: We conducted a cross-sectional retrospective study in a single center tertiary referral hospital. We included adult patients above 18 years of age with infection due to CRE between January 1, 2018, to December 30, 2019.  Results: During this period, 76 cases were studied. The mean age of the cases was 54 years. The majority were immunosuppressed and admitted to the intensive care unit. The most frequent risk factors associated with CRE infection among study subjects included prior antibiotics in the preceding three months and prior hospital admission in the last one year. Klebsiella pneumoniae (77%) represented the most isolated organism. All-cause intensive care unit and in-hospital mortality were significantly higher among patients with pneumonia and bacteremia.  Conclusions: CRE infections are associated with higher morbidity and mortality specifically in patients who presented with pneumonia and bacteremia. High resistance rate and limited treatment options have made a great variability in the clinical practice. Appropriate definitive treatment of CRE infections, strict infection control measures, and antimicrobial stewardship program activation are essential., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Al Khamis et al.)

Published
2022
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12. Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial.

Author

Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, and Paterson DL

Subjects
Adult, Aged, Anti-Bacterial Agents adverse effects, Anti-Bacterial Agents pharmacology, Bacteremia drug therapy, Cause of Death, Ceftriaxone pharmacology, Drug Resistance, Bacterial, Escherichia coli drug effects, Escherichia coli Infections mortality, Female, Humans, Klebsiella Infections mortality, Male, Meropenem, Middle Aged, Penicillanic Acid adverse effects, Penicillanic Acid therapeutic use, Piperacillin adverse effects, Piperacillin therapeutic use, Piperacillin, Tazobactam Drug Combination, Thienamycins adverse effects, Anti-Bacterial Agents therapeutic use, Bacteremia mortality, Escherichia coli Infections drug therapy, Klebsiella Infections drug therapy, Klebsiella pneumoniae drug effects, Penicillanic Acid analogs & derivatives, Thienamycins therapeutic use
Abstract

Importance: Extended-spectrum β-lactamases mediate resistance to third-generation cephalosporins (eg, ceftriaxone) in Escherichia coli and Klebsiella pneumoniae. Significant infections caused by these strains are usually treated with carbapenems, potentially selecting for carbapenem resistance. Piperacillin-tazobactam may be an effective "carbapenem-sparing" option to treat extended-spectrum β-lactamase producers., Objectives: To determine whether definitive therapy with piperacillin-tazobactam is noninferior to meropenem (a carbapenem) in patients with bloodstream infection caused by ceftriaxone-nonsusceptible E coli or K pneumoniae., Design, Setting, and Participants: Noninferiority, parallel group, randomized clinical trial included hospitalized patients enrolled from 26 sites in 9 countries from February 2014 to July 2017. Adult patients were eligible if they had at least 1 positive blood culture with E coli or Klebsiella spp testing nonsusceptible to ceftriaxone but susceptible to piperacillin-tazobactam. Of 1646 patients screened, 391 were included in the study., Interventions: Patients were randomly assigned 1:1 to intravenous piperacillin-tazobactam, 4.5 g, every 6 hours (n = 188 participants) or meropenem, 1 g, every 8 hours (n = 191 participants) for a minimum of 4 days, up to a maximum of 14 days, with the total duration determined by the treating clinician., Main Outcomes and Measures: The primary outcome was all-cause mortality at 30 days after randomization. A noninferiority margin of 5% was used., Results: Among 379 patients (mean age, 66.5 years; 47.8% women) who were randomized appropriately, received at least 1 dose of study drug, and were included in the primary analysis population, 378 (99.7%) completed the trial and were assessed for the primary outcome. A total of 23 of 187 patients (12.3%) randomized to piperacillin-tazobactam met the primary outcome of mortality at 30 days compared with 7 of 191 (3.7%) randomized to meropenem (risk difference, 8.6% [1-sided 97.5% CI, -∞ to 14.5%]; P = .90 for noninferiority). Effects were consistent in an analysis of the per-protocol population. Nonfatal serious adverse events occurred in 5 of 188 patients (2.7%) in the piperacillin-tazobactam group and 3 of 191 (1.6%) in the meropenem group., Conclusions and Relevance: Among patients with E coli or K pneumoniae bloodstream infection and ceftriaxone resistance, definitive treatment with piperacillin-tazobactam compared with meropenem did not result in a noninferior 30-day mortality. These findings do not support use of piperacillin-tazobactam in this setting., Trial Registration: anzctr.org.au Identifiers: ACTRN12613000532707 and ACTRN12615000403538 and ClinicalTrials.gov Identifier: NCT02176122.

Published
2018
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