Multi-drug resistant infections (MDRO) have been reducing the world’s antimicrobial arsenal for decades. It is critical to find new treatments for these infections – and in turn to prevent the development of resistance to new therapies. Antimicrobial susceptibility testing (AST) is therefore highly important to ensuring the efficacy of antimicrobials throughout treatment. To help meet this need, bioMérieux is expanding our classic ETEST® range with more AST tests for newer antimicrobials developed for serious infections caused by multi-drug resistant organisms. The newest additions to the ETEST® range are ETEST® Ceftolozane/Tazobactam (C/T) and ETEST®Ceftazidime/Avibactam (CZA 256) for susceptibility testing of ceftolozane-tazobactam and ceftazidime-avibactam combination drugs, respectively. ETEST® is a valuable susceptibility test widely appreciated for its capacity to provide on-scale MIC values [not just the interpretive category (S, I, or R)], in as little as 16 hours incubation. The precise results provided by ETEST® can help clinicians determine the best treatment and adjust therapy for the most effective patient outcomes. Marketed under the name Zerbaxa®*, ceftolozane-tazobactam is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including acute pyelonephritis, and, in combination with metronidazole, complicated intra-abdominal infections (cIAI).1,2 Ceftazidime/avibactam, marketed as Avycaz®** in the U.S. and Zavicefta®*** in Europe, is used to treat certain multidrug-resistant Gram-negative infections.3,4 It is indicated for complicated intra-abdominal infections (cIAI) in combination with metronidazole, as well as for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), in patients over 18 years of age. The Ceftolozane-tazobactam and ceftazidime-avibactam were both developed to treat serious infections resistant to other therapies. Underscoring their importance, both have received Qualified Infectious Disease Product (QIDP) designation by the US Food and Drug Administration (FDA).5 The QIDP program is part of the Generating Antibiotic Incentives Now (GAIN) Act, a 2012 congressional incentive program for the development of antimicrobials for serious, resistant infections. Among other things, it enables FDA fast-tracking and greater regulatory flexibility to address unmet medical need for serious, life-threatening infections. The microbiology lab plays a critical role in the fight against multi-drug resistant organisms. bioMérieux has been a partner to labs for over 50 years with innovations by microbiologists, for microbiologists. We are committed to the ongoing development of integrated solutions for faster, accurate results that contribute to improved patient care for serious infections.
*Merck
**Allergan
***Astra Zeneca/Pfizer
References:
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206829lbl.pdf
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http://link.springer.com/article/10.1007%2Fs40265-013-0168-2
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Mosley, J.F. et. al. Ceftazidime-Avibactam (Avycaz) For the Treatment of Complicated Intra-Abdominal and Urinary Tract Infections. Pharmacy & Therapeutics. 41(8): 479–483. 2016 Aug.
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Nicolau, D.P. Focus on ceftazidime-avibactam for optimizing outcomes in complicated intra-abdominal and urinary tract infections. Expert Opin Investig Drugs. 2015;24(9):1261-73.. Epub 2015 Jul 6.
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https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf