Environmental Microbiomes for Ciai in Combination with Metronidazole a POWERFUL CHOICE 1,3,4

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Environmental Microbiomes for Ciai in Combination with Metronidazole a POWERFUL CHOICE 1,3,4 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. Call for nominations for the position of VP Corporate Affairs Ǧ ǯ Ǥ ǡǡ Ǥ͵ǡ ͷǤ Ǧ ǤǡǤ ǡ Ǥ ̵Ǥ Ǥ Ǥ Ǥ ͵ͳ ǡʹͲͳͺǤ ȋ̷Ǥ ǤȌǤ Nomination for the position of VP Corporate Affairs of The Australian Society for Microbiology Inc ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ Proposer (FASM / MASM / SASM / Honorary Life Member) ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ Seconder (FASM / MASM / SASM / Honorary Life Member) ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ I accept this nomination for the position of VP Corporate Affairs of the ASM ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ ̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴ Statement by nominee (no more than 100 words): The Australian Society for Microbiology Inc. 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. 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