Environmental Microbiomes for Ciai in Combination with Metronidazole a POWERFUL CHOICE 1,3,4
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OFFICIALOFFICIAL JOURNALJOURNAL OFOF THETHE AUSTRALIAN SOCIETY FOR MICROBIOLOGY INC.INC. VolumeVolume 3939 NumberNumber 11 MarchMarch 20182018 Environmental Microbiomes For cIAI in combination with metronidazole A POWERFUL CHOICE 1,3,4 ZERBAXA + metronidazole had a high level of antimicrobial activity against P. aeruginosa1,2,4 In cIAI, all patients in the ME population with P. aeruginosa infection at baseline had a 100% clinical cure rate with ZERBAXA plus metronidazole (n=26/26) vs. 93.1% with meropenem (n=27/29) (subgroup analysis; p values not stated).4 ZERBAXA has a low potential for development of resistance in P. aeruginosa.1,2 ZERBAXA is stable against common P. aeruginosa resistance mechanisms in vitro^ including:2 • Overexpression of AmpC ^in vitro activity does not necessarily • Increased express of efflux pumps predict clinical efficacy • Reduced expression of carbapenem-specific porins (OprD) cIAI=complicated intra-abdominal infection; CI=confidence interval; MITT=microbiological intent-to-treat; ME=microbiologically evaluable Study design in cIAI: A total of 993 adults hospitalised with a cIAI were randomised in a multinational, double-blind, phase 3, non-inferiority trial comparing ZERBAXA (ceftolozane 1000 mg and tazobactam 500 mg) plus metronidazole (0.5 g) intravenously every 8 hours with meropenem (1 g) intravenously every 8 hours for 4–14 days. Complicated intra- abdominal infections included appendicitis, cholecystitis, diverticulitis, gastric/duodenal perforation, perforation of the intestine, and other causes of intra-abdominal abscesses and peritonitis.3 Primary endpoint, clinical cure, was defined as complete resolution or significant improvement in signs and symptoms of the index infection at the test of cure visit (24–32 days from start of therapy), using a non-inferiority margin of 10%. The primary efficacy analysis population was the microbiological intent to-treat (MITT) population which included all patients who had at least one baseline intra-abdominal pathogen regardless of the susceptibility to study drug.3 In cIAI, clinical cure rate for ZERBAXA + metronidazole Secondary endpoint was the same end point (n=389) was non-inferior to meropenem (n=417) in the MITT in the microbiologically evaluable (ME) population at test of cure, 83% vs 87.3% (weighted difference, population, which included all protocol- -4.2%; 95% CI, -8.91, 0.54; p value not stated).3 adherent MITT patients.3 Before prescribing, please review the Product Information. The Product Information is available upon request from MSD or can be accessed at www.msdinfo.com.au/zerbaxapi PBS Information: This product is not listed on the PBS. ZERBAXA (ceftolozane/tazobactam 1000 mg/500 mg): Indications: Treatment of infections in adults suspected or proven to be caused by designated susceptible microorganisms: complicated intra-abdominal infections in combination with metronidazole; complicated urinary tract infections, including pyelonephritis. Contraindications: Hypersensitivity to any component of this product; known hypersensitivity to members of cephalosporin class or other members of ß-lactam class. Precautions: Hypersensitivity; clostridium difficile - associated diarrhoea; severely immunocompromised patients receiving immunosuppressive therapy; renal impairment; fertility effects, use in pregnancy, lactation; children <18 years. Pregnancy Category: B1. Interactions: Drugs that inhibit OAT1 or OAT3 (e.g., probenecid, diclofenac, cimetidine) may increase tazobactam plasma concentrations. Adverse Effects: Most common (5% or greater in either indication) were nausea; diarrhoea; headache; pyrexia; others, see full PI. Dosage: Complicated intra-abdominal infections: 1000 mg ceftolozane/500mg tazobactam (with metronidazole 500 mg IV) every 8 hours by IV infusion (over 1 hour) for 4-14 days; complicated urinary tract infections, including pyelonephritis: 1000 mg ceftolozane/500mg tazobactam every 8 hours by IV infusion (over 1 hour) for 7 days; for dosage in renal impairment, see full PI. Based on PI dated 7 August 2017. References: 1. ZERBAXA Product Information. 4 November 2015. 2. Zhanel GG, Chung P, Adam H, Zelenitsky S, Denisuik A et al. 2014. Ceftolozane/ Tazobactam: A Novel Cephalosporin/ß-Lactamase Inhibitor Combination with Activity Against Multidrug-Resistant Gram-Negative Bacilli. Drugs, 74(1):31–51. 3. Solomkin J, Hershberger E, Miller B, Popejoy M, Friedland I et al. 2015. Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI). Clin Infect Dis, 60(10):1462–71. 4. Miller B, Popejoy MW, Hershberger E, Steenbergen JN, Alverdy J. 2016. Characteristics and Outcomes of Complicated Intra-abdominal Infections Involving Pseudomonas aeruginosa from a Randomized, Double-Blind, Phase 3 Ceftolozane-Tazobactam Study. Antimicrob Agents Chemother, 60(7):4387-90. Copyright © 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 1 – Building A, 26 Talavera Road, Macquarie Park NSW 2113. INFC-1246655-0000. First issued February 2018. Bloe Agency MSD13018. 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OFFICIAL JOURNAL OF THE AUSTRALIAN SOCIETY FOR MICROBIOLOGY INC. 9/397 Smith Street Fitzroy, Vic. 3065 Tel: 1300 656 423 Volume 39 Number 1 March 2018 Fax: 03 9329 1777 Email: [email protected] www.theasm.org.au Contents ABN 24 065 463 274 Vertical Transmission 2 For Microbiology Australia correspondence, see address below. Roy Robins-Browne 2 Editorial team Guest Editorial 3 Prof. Ian Macreadie, Mrs Hayley Macreadie Environmental microbiomes 3 and Mrs Rebekah Clark Linda L Blackall Editorial. Board Dr Ipek Kurtböke (Chair) Prof. Wieland Meyer In Focus 5 Prof. Ross Barnard Mr Chris Owens The importance of resolving biogeographic patterns Prof. Mary Barton Prof. William Rawlinson of microbial microdiversity 5 Prof. Linda Blackall Prof. Roy Robins-Browne Alexander B Chase and Jennifer BH Martiny Dr Chris Burke Dr Paul Selleck Dr Narelle Fegan Dr Erin Shanahan Viruses in corals: hidden drivers of coral bleaching and disease? 9 Dr Gary Lum Dr David Smith Patrick Buerger and Madeleine JH van Oppen Dr Sam Manna Ms Helen Smith Dr John Merlino Dr Jack Wang Swimming in the sea: chemotaxis by marine bacteria 12 Justin R Seymour and Jean-Baptiste Raina Subscription rates Current subscription rates are available Emerging microbiome technologies for sustainable increase from the ASM Melbourne offi ce. in farm productivity and environmental security 17 Editorial correspondence Brajesh K Singh, Pankaj Trivedi, Saurabh Singh, Prof. Ian Macreadie Catriona A Macdonald and Jay Prakash Verma Tel: 0402 564 308 (Ian) Email: [email protected] Manipulating the soil microbiome for improved nitrogen management 24 Hang-Wei Hu and Ji-Zheng He Published four times a year in print and open access online by Life without water: how do bacteria generate biomass in desert ecosystems? 28 Sean Bay, Belinda Ferrari and Chris Greening Rock-art microbiome: influences on long term preservation of historic and culturally important engravings 33 Deirdre B Gleeson, Matthias Leopold, Benjamin Smith and John Black Unipark, Building 1, Level 1 The geomicrobiology of mining environments 37 195 Wellington Road, Clayton, Vic. 3168 http://microbiology.publish.csiro.au Talitha C Santini and Emma J Gagen Publishing enquiries Establishing microbial baselines to identify indicators of coral reef health 42 Jenny Foster Bettina Glasl, David G Bourne, Pedro R Frade and Nicole S Webster Email: [email protected] Production enquiries Under the Microscope 47 Helen Pavlatos Engineering biological nitrogen removal in wastewater treatment Email: [email protected] via the control of nitrite oxidising bacteria using free nitrous acid 47 Advertising enquiries Andrew Elohim Laloo and Philip L Bond Tel: 03 9545 8400 Email: [email protected] Microbial cooperation improves bioleaching recovery rates 50 © 2018 The Australian Society for Microbiology Inc. Melissa K Corbett and Elizabeth LJ Watkin The ASM, through CSIRO Publishing, reserve all rights to the content, artwork and photographs in Microbiology Understanding microbiomes through trait-based ecology 53 Australia. Permission to reproduce text, photos