Openly accessible

Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial

Harris, Patrick N.A., Peleg, Anton Y., Iredell, Jon, Ingram, Paul R., Miyakis, Spiros, Stewardson, Andrew J., Rogers, Benjamin A., McBryde, Emma S., Roberts, Jason A., Lipman, Jeff, Athan, Eugune, Paul, Sanjoy K., Baker, Peter, Harris-Brown, Tiffany and Paterson, David L. 2015, Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial, Trials, vol. 16, Article Number : 24, pp. 1-8, doi: 10.1186/s13063-014-0541-9.

Attached Files
Name Description MIMEType Size Downloads
athan-meropenemversus-2015.pdf Published version application/pdf 726.87KB 75

Title Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial
Formatted title Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial
Author(s) Harris, Patrick N.A.
Peleg, Anton Y.
Iredell, Jon
Ingram, Paul R.
Miyakis, Spiros
Stewardson, Andrew J.
Rogers, Benjamin A.
McBryde, Emma S.
Roberts, Jason A.
Lipman, Jeff
Athan, EuguneORCID iD for Athan, Eugune orcid.org/0000-0001-9838-6471
Paul, Sanjoy K.
Baker, Peter
Harris-Brown, Tiffany
Paterson, David L.
Journal name Trials
Volume number 16
Season Article Number : 24
Start page 1
End page 8
Total pages 8
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2015
ISSN 1745-6215
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Extended-spectrum beta-lactamase
ESBL
Plasmid-AmpC
Therapy
Resistance
Beta-lactam/beta-lactamase inhibitor
Carbapenem
Clinical trial
SPECTRUM BETA-LACTAMASES
PNEUMONIAE BACTEREMIA
ENTEROBACTERIACEAE
ANTIBIOTICS
DISEASES
UPDATE
Summary BACKGROUND: Gram-negative bacteria such as Escherichia coli or Klebsiella spp. frequently cause bloodstream infections. There has been a worldwide increase in resistance in these species to antibiotics such as third generation cephalosporins, largely driven by the acquisition of extended-spectrum beta-lactamase or plasmid-mediated AmpC enzymes. Carbapenems have been considered the most effective therapy for serious infections caused by such resistant bacteria; however, increased use creates selection pressure for carbapenem resistance, an emerging threat arising predominantly from the dissemination of genes encoding carbapenemases. Recent retrospective data suggest that beta-lactam/beta-lactamase inhibitor combinations, such as piperacillin-tazobactam, may be non-inferior to carbapenems for the treatment of bloodstream infection caused by extended-spectrum beta-lactamase-producers, if susceptible in vitro. This study aims to test this hypothesis in an effort to define carbapenem-sparing alternatives for these infections.

METHODS/DESIGN: The study will use a multicentre randomised controlled open-label non-inferiority trial design comparing two treatments, meropenem (standard arm) and piperacillin-tazobactam (carbapenem-sparing arm) in adult patients with bacteraemia caused by E. coli or Klebsiella spp. demonstrating non-susceptibility to third generation cephalosporins. Recruitment is planned to occur in sites across three countries (Australia, New Zealand and Singapore). A total sample size of 454 patients will be required to achieve 80% power to determine non-inferiority with a margin of 5%. Once randomised, definitive treatment will be for a minimum of 4 days, but up to 14 days with total duration determined by treating clinicians. Data describing demographic information, antibiotic use, co-morbid conditions, illness severity, source of infection and other risk factors will be collected. Vital signs, white cell count, use of vasopressors and days to bacteraemia clearance will be recorded up to day 7. The primary outcome measure will be mortality at 30 days, with secondary outcomes including days to clinical and microbiological resolution, microbiological failure or relapse, isolation of a multi-resistant organism or Clostridium difficile infection.
Language eng
DOI 10.1186/s13063-014-0541-9
Field of Research 1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Socio Economic Objective 929999 Health not elsewhere classified
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30081711

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
Open Access Collection
Connect to link resolver
 
Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved.

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.

Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 45 times in TR Web of Science
Scopus Citation Count Cited 48 times in Scopus
Google Scholar Search Google Scholar
Access Statistics: 395 Abstract Views, 76 File Downloads  -  Detailed Statistics
Created: Thu, 25 Feb 2016, 09:42:28 EST

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.