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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with e coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance
JAMA - Journal of the American Medical Association, Volume 320, No. 10, Year 2018
Notification
URL copied to clipboard!
Description
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. © 2018 American Medical Association. All rights reserved.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC6143100/bin/jama-320-984-s001.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC6143100/bin/jama-320-984-s002.pdf
Authors & Co-Authors
Harris, Patrick N.A.
Australia, Brisbane
The University of Queensland
Australia, Brisbane
Royal Brisbane and Women's Hospital
Australia, Woolloongabba
Princess Alexandra Hospital
Tambyah, Paul Ananth
Singapore, Singapore City
National University Hospital
Lye, David Chien
Australia, Brisbane
Royal Brisbane and Women's Hospital
Singapore, Singapore City
National University of Singapore
Singapore, Singapore City
Tan Tock Seng Hospital
Singapore, Singapore City
Lee Kong Chian School of Medicine
Mo, Yin
Singapore, Singapore City
National University Hospital
Lee, Tauhong
Singapore, Singapore City
National University of Singapore
Singapore, Singapore City
Tan Tock Seng Hospital
Singapore, Singapore City
Lee Kong Chian School of Medicine
Yilmaz, Mesut
Turkey, Istanbul
İstanbul Medipol Üniversitesi
Alenazi, Thamer H.
Saudi Arabia, Riyadh
King Saud Bin Abdulaziz University for Health Sciences
Arabi, Yaseen M.
Saudi Arabia, Riyadh
King Saud Bin Abdulaziz University for Health Sciences
Falcone, Marco
Italy, Rome
Sapienza Università Di Roma
Bassetti, Matteo
Italy, Udine
Università Degli Studi Di Udine
Righi, Elda
Italy, Udine
Università Degli Studi Di Udine
Rogers, Benjamin A.
Australia, Clayton
Faculty of Medicine, Nursing and Health Sciences
Australia, Clayton
Monash Health
Kanj, Souha S.
Lebanon, Beirut
American University of Beirut
Bhally, Hasan S.
New Zealand, Auckland
North Shore Hospital
Iredell, Jonathan R.
Australia, Sydney
The University of Sydney
Australia, Sydney
Westmead Hospital
Mendelson, Marc
South Africa, Cape Town
University of Cape Town
Boyles, Tom H.
South Africa, Cape Town
University of Cape Town
Looke, David F.M.
Australia, Woolloongabba
Princess Alexandra Hospital
Australia, Brisbane
The University of Queensland
Miyakis, Spiros
Australia, Wollongong
School of Medicine
Australia, Wollongong
Illawarra Health and Medical Research Institute
Australia, Wollongong
Wollongong Hospital
Walls, Genevieve B.
New Zealand, Auckland
Middlemore Hospital, Auckland
Al Khamis, Mohammed
Saudi Arabia, Dammam
King Fahad Specialist Hospital, Dammam
Zikri, Ahmed
Saudi Arabia, Dammam
King Fahad Specialist Hospital, Dammam
Crowe, Amy L.
Australia, Fitzroy
St. Vincent's Hospital Melbourne
Ingram, Paul Robert
Australia, Perth
The University of Western Australia
Australia, Perth
Fiona Stanley Hospital
Australia, Perth
Pathwest Laboratory Medicine wa
Daneman, Nick
Canada, Toronto
Sunnybrook Health Sciences Centre
Griffin, Paul M.
Australia, Brisbane
The University of Queensland
Australia, Brisbane
Mater Health Services Brisbane
Australia, Brisbane
Qimr Berghofer Medical Research Institute
Athan, E.
Australia, Geelong
Deakin University
Lorenc, Penelope
Unknown Affiliation
Baker, Peter John
Australia, Brisbane
The University of Queensland
Roberts, Leah W.
Australia, Brisbane
The University of Queensland
Beatson, Scott A.
Australia, Brisbane
The University of Queensland
Peleg, Anton Y.
Australia, Clayton
Monash University
Australia, Melbourne
The Alfred
Australia, Brisbane
Royal Brisbane and Women's Hospital
Harris-Brown, Tiffany M.
Australia, Brisbane
The University of Queensland
Paterson, David L.
Australia, Brisbane
Royal Brisbane and Women's Hospital
Australia, Brisbane
The University of Queensland
McNamara, John F.
Unknown Affiliation
Sieler, R.
Unknown Affiliation
Garlick, Jill S.
Unknown Affiliation
Costa, J.
Unknown Affiliation
Roney, Janine J.
Unknown Affiliation
Pratt, Nigel F.
Unknown Affiliation
Tabaja, Hussam Z.
Unknown Affiliation
Kmeid, Joumana G.
Unknown Affiliation
Tayyar, Ralph
Unknown Affiliation
El-Zein, Said
Unknown Affiliation
Jones, Sandra Braun
Unknown Affiliation
Cowan, Raquel U.
Unknown Affiliation
Tai, A.
Unknown Affiliation
Lin, Belinda Bin
Unknown Affiliation
Rad, Babak
Unknown Affiliation
MacMorran, Eleanor
Unknown Affiliation
Pollard, James G.D.
Unknown Affiliation
Dinleyici, Rümeysa
Unknown Affiliation
Istanbullu, Ayse
Unknown Affiliation
Ceylan, Bahadır
Unknown Affiliation
Mert, Ali Murat
Unknown Affiliation
Hashhoush, Mai S.
Unknown Affiliation
Dalwi, T.
Unknown Affiliation
Korman, Tony M.
Unknown Affiliation
Azzam, R.
Unknown Affiliation
Birrell, Michael T.
Unknown Affiliation
Hughes, Carly M.
Unknown Affiliation
Khan, Sabrina D.
Unknown Affiliation
Lau, J.
Unknown Affiliation
Lee, Lawrence Soon U.
Unknown Affiliation
Lim, Kruy
Unknown Affiliation
Lin, Y. D.
Unknown Affiliation
Lister, D.
Unknown Affiliation
New, Daniel D.
Unknown Affiliation
Rafiei, Nastaran
Unknown Affiliation
Tai, Alex Y.C.
Unknown Affiliation
Trad, Mohamad Ali
Unknown Affiliation
Aye Yeung, V.
Unknown Affiliation
McBride, Stephen J.
Unknown Affiliation
Holland, David James
Unknown Affiliation
Hopkins, C.
Unknown Affiliation
Luey, Christopher E.
Unknown Affiliation
Taylor, Susan L.
Unknown Affiliation
Morpeth, Susan Claire
Unknown Affiliation
Finney, Melissa
Unknown Affiliation
Martin, M.
Unknown Affiliation
Holland, Umit
Unknown Affiliation
Ali, Jaminah M.
Unknown Affiliation
Jureen, Roland
Unknown Affiliation
Underwood, Neil P.
Unknown Affiliation
Henderson, Andrew J.
Unknown Affiliation
Runnegar, Naomi J.
Unknown Affiliation
Slavin, Monica A.
Unknown Affiliation
Robinson, Owen J.
Unknown Affiliation
Rishu, Asgar H.
Unknown Affiliation
Shawkat, S.
Unknown Affiliation
Fish, Janaye
Unknown Affiliation
Chin Liew, K.
Unknown Affiliation
Newton, Peter J.
Unknown Affiliation
Merelli, M.
Unknown Affiliation
Carnelutti, Alessia
Unknown Affiliation
Ussai, Silvia
Unknown Affiliation
Pecori, Davide
Unknown Affiliation
Izharuddin, Ezlyn Binti
Unknown Affiliation
Young, Barnaby Edward
Unknown Affiliation
Richards, Guy Antony
Unknown Affiliation
Smith, Orla M.
Unknown Affiliation
Alli, Ahmad
Unknown Affiliation
Wright, Brian Joseph
Unknown Affiliation
Grey, Corina
Unknown Affiliation
Wasserman, Sean A.
Unknown Affiliation
Richi, Hanie
Unknown Affiliation
Alanazi, Nouf Basheer
Unknown Affiliation
Franzetti, Fabio
Unknown Affiliation
de Kock, Elsabe J.E.
Unknown Affiliation
Russo, Alessandro
Unknown Affiliation
Dentone, Chiara
Unknown Affiliation
Statistics
Citations: 515
Authors: 111
Affiliations: 33
Identifiers
Doi:
10.1001/jama.2018.12163
ISSN:
00987484
Study Design
Randomised Control Trial
Cross Sectional Study
Participants Gender
Female