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

Patrick N. A. Harris1, Anton Y. Peleg2, Jonathan R. Iredell3, Paul R. Ingram4,5, Spiros Miyakis6, Andrew J. Stewardson7, Benjamin A. Rogers8, Emma S. McBryde9, Jason A. Roberts10, Jeffrey Lipman10, Eugene Athan11, Sanjoy K. Paul12, Peter Baker13, Tiffany Harris‐Brown1, David L. Paterson1
1University of Queensland-Centre for Clinical Research, Brisbane, Australia.
2Department of Infectious Diseases, The Alfred Hospital, Melbourne, VIC, Australia
3Westmead Millenium Institute for Medical Research, Westmead Hospital, Sydney, NSW, Australia.
4Department of Microbiology and Infectious Diseases, Royal Perth Hospital, Perth, Australia
5School of Pathology and Laboratory Medicine, University of Western Australia, Crawley, Australia
6Department of Infectious Diseases, School of Medicine, University of Wollongong and The Wollongong Hospital, Wollongong, NSW, Australia.
7Department of Infectious Diseases, Austin Health, Melbourne, VIC, Australia.
8Monash Infectious Disease, Monash Health, Clayton, VIC, Australia
9Victorian Infectious Diseases Unit, Royal Melbourne Hospital, Melbourne, VIC, Australia.
10Burns, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, QLD, Australia
11Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC, Australia
12Clinical Trials and Biostatistics Unit, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia
13Queensland Clinical Trials and Biostatistics Centre, University of Queensland, Brisbane, QLD, Australia.

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Cohen J, Cristofaro P, Carlet J, Opal S. New method of classifying infections in critically ill patients. Crit Care Med. 2004;32(7):1510–26.

Pitout JD, Laupland KB. Extended-spectrum beta-lactamase-producing Enterobacteriaceae: an emerging public-health concern. Lancet Infect Dis. 2008;8(3):159–66.

Paterson DL, Bonomo RA. Extended-spectrum beta-lactamases: a clinical update. Clin Microbiol Rev. 2005;18(4):657–86.

de Kraker MEA, Wolkewitz M, Davey PG, Koller W, Berger J, Nagler J, et al. Burden of antimicrobial resistance in European hospitals: excess mortality and length of hospital stay associated with bloodstream infections due to Escherichia coli resistant to third-generation cephalosporins. J Antimicrob Chemother. 2011;66(2):398–407.

Paterson DL, Ko WC, Von Gottberg A, Mohapatra S, Casellas JM, Goossens H, et al. Antibiotic therapy for Klebsiella pneumoniae bacteremia: implications of production of extended-spectrum beta-lactamases. Clin Infect Dis. 2004;39(1):31–7.

Vardakas KZ, Tansarli GS, Rafailidis PI, Falagas ME. Carbapenems versus alternative antibiotics for the treatment of bacteraemia due to Enterobacteriaceae producing extended-spectrum beta-lactamases: a systematic review and meta-analysis. J Antimicrob Chemother. 2012;67(12):2793–803.

Rodriguez-Bano J, Navarro MD, Retamar P, Picon E, Pascual A. 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. 2012;54(2):167–74.

Peralta G, Lamelo M, Alvarez-Garcia P, Velasco M, Delgado A, Horcajada JP, et al. Impact of empirical treatment in extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella spp. bacteremia. A multicentric cohort study. BMC Infect Dis. 2012;12:245.

McLaughlin M, Advincula MR, Malczynski M, Qi C, Bolon M, Scheetz MH. Correlations of antibiotic use and carbapenem resistance in Enterobacteriaceae. Antimicrob Agents Chemother. 2013;57(10):5131–3.

Gupta N, Limbago BM, Patel JB, Kallen AJ. Carbapenem-resistant Enterobacteriaceae: epidemiology and prevention. Clin Infect Dis. 2011;53(1):60–7.

Boucher HW, Talbot GH, Benjamin Jr DK, Bradley J, Guidos RJ, Jones RN, et al. Infectious Diseases Society of A: 10 × ′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(12):1685–94.

Drawz SM, Papp-Wallace KM, Bonomo RA. New beta-lactamase inhibitors: a therapeutic renaissance in an MDR world. Antimicrob Agents Chemother. 2014;58(4):1835–46.

Tam VH, Ledesma KR, Chang KT, Wang TY, Quinn JP. Killing of Escherichia coli by beta-lactams at different inocula. Diagn Microbiol Infect Dis. 2009;64(2):166–71.

Rice LB, Carias LL, Hujer AM, Bonafede M, Hutton R, Hoyen C, et al. High-level expression of chromosomally encoded SHV-1 beta-lactamase and an outer membrane protein change confer resistance to ceftazidime and piperacillin-tazobactam in a clinical isolate of Klebsiella pneumoniae. Antimicrob Agents Chemother. 2000;44(2):362–7.

Jacoby GA. AmpC beta-lactamases. Clin Microbiol Rev. 2009;22(1):161–82.

Chen YH, Hsueh PR, Badal RE, Hawser SP, Hoban DJ, Bouchillon SK, et al. Antimicrobial susceptibility profiles of aerobic and facultative Gram-negative bacilli isolated from patients with intra-abdominal infections in the Asia-Pacific region according to currently established susceptibility interpretive criteria. J Infect. 2011;62(4):280–91.

Tzouvelekis LS, Markogiannakis A, Psichogiou M, Tassios PT, Daikos GL. Carbapenemases in Klebsiella pneumoniae and other Enterobacteriaceae: an evolving crisis of global dimensions. Clin Microbiol Rev. 2012;25(4):682–707.

Rodriguez-Bano J, Navarro MD, Retamar P, Picon E, Pascual A. Extended-Spectrum Beta-Lactamases-Red Espanola de Investigacion en Patologia Infecciosa/Grupo de Estudio de Infeccion Hospitalaria G. 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. 2012;54(2):167–74.

Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, Group C. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594–604.

Breakpoint tables for interpretation of MICs and zone diameters version 4.0. Available from: http://www.eucast.org . Accessed 6th December 2014.

Paterson DL, Ko WC, Von Gottberg A, Mohapatra S, Casellas JM, Goossens H, et al. International prospective study of Klebsiella pneumoniae bacteremia: implications of extended-spectrum beta-lactamase production in nosocomial Infections. Ann Intern Med. 2004;140(1):26–32.

Chow S-C, Hansheng W, Shao J. Sample size calculations in clinical research. 2nd ed. Boca Raton: Chapman Hall; 2007.

Harris PNA, Mo Y, Jureen R, Chew J, Ali J, Paterson DL, Tambyah PA. Meropenem and piperacillin-tazobactam have comparable outcomes in treatment of bloodstream infections caused by extended spectrum beta-lactamase producing E.coli and Klebsiellae. Abstract number 486, IDWeek. Philadelphia, PA: 8 to 12 October 2014. Available from: https://idsa.confex.com/idsa/2014/webprogram/Paper46679.html . Accessed 12th Jan 2015.

EUCAST guidelines for detection of resistance mechanisms and specific resistances of clinical and/or epidemiological importance. Available from: http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Resistance_mechanisms/EUCAST_detection_of_resistance_mechanisms_v1.0_20131211.pdf . Accessed 26th Jan 2015.

Paterson DL. Determining research priorities for clinician-initiated trials in infectious diseases. Med J Aust. 2013;198(5):270–2.

Spellberg B, Bartlett JG, Gilbert DN. The future of antibiotics and resistance. N Engl J Med. 2013;368(4):299–302.