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Formerly VNRX-5133) Against a 2122 Palmer Drive 02581 Schaumburg, IL 60173 USA European 2018-2020 Surveillance Collection of Pseudomonas Aeruginosa
IHMA, Inc. Antimicrobial Activity of Cefepime in Combination with Taniborbactam (formerly VNRX-5133) Against a 2122 Palmer Drive 02581 Schaumburg, IL 60173 USA European 2018-2020 Surveillance Collection of Pseudomonas aeruginosa www.ihma.com M. Hackel1, M. Wise1, D. Sahm1 1IHMA, Inc., Schaumburg, IL, USA INTRODUCTION RESULTS RESULTS SUMMARY Taniborbactam, (formerly VNRX-5133), is a Table 1. In vitro activity of cefepime-taniborbactam and Figure 1. MIC distribution of cefepime, cefepime-taniborbactam, and comparators Figure 3. MIC distribution of cefepime, cefepime-taniborbactam, and comparators . Cefepime-taniborbactam demonstrated potent in vitro activity novel cyclic boronate-based broad-spectrum β- comparator agents against 2,035 P. aeruginosa from against 2,035 Pseudomonas aeruginosa from Europe against 595 meropenem-non-susceptible Pseudomonas aeruginosa from Europe (MIC50/90, 2/8 mg/L; 95.6% inhibited at ≤8 mg/L) against P. lactamase inhibitor with potent and selective Europe aeruginosa isolates from Europe (Table 1). direct inhibitory activity against both serine- and Phenotype (n; percent of total) Antimicrobial %S %I* %R MIC50 MIC90 . Provisional susceptibility rates to cefepime-taniborbactam and All (2,035) Cefepime-taniborbactam 95.6 -- 4.4 2 8 Cefepime (FEP) metallo-β-lactamases (Ambler Classes A, B, C Cefepime 0.0 79.0 21.0 4 32 Cefepime (FEP) Ceftazidime 0.0 75.8 24.2 4 >32 Cefepime-taniborbactam (FTB) FTB 86.6% ≤8 µg/mL ceftolozane-tazobactam, respectively, were 73.2% and 13.2% vs and D). Taniborbactam greatly enhances -
IDSA Guideline Review
1 Infectious Diseases Society of America Antimicrobial Resistant Treatment Guidance: Gram- Negative Bacterial Infections A Focus on Extended-Spectrum β-lactamase Producing Enterobacterales (ESBL-E), Carbapenem- Resistant Enterobacterales (CRE), and Pseudomonas aeruginosa with Difficult-to-Treat Resistance (DTR- P. aeruginosa) Guideline Summary by Kendra Suder, PharmD Candidate General Recommendations Considerations for choosing empiric therapy: o Local susceptibility patterns/ antibiogram o Patient’s previous organisms isolated & susceptibility data in the last 6 months o Antibiotic exposure in the last 30 days What if a patient was empirically placed on an antibiotic regimen that is now considered inactive against the organism based on susceptibility data? o If an inactive agent was started empirically for cystitis and patient improves, no change in antibiotic or extension of therapy is necessary o However, for other types of infections, guidelines recommend a change to an active regimen for a full treatment course (dated from the start of active therapy) Extended-Spectrum β-Lactamase-Producing Enterobacterales (ESBL-E) Extended-spectrum β-lactamase o Enzymes that inactivate most penicillins, cephalosporins, and aztreonam o Most commonly produced by Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, and Proteus mirabilis (guideline recommendations refer to ESBL-E infections caused by these organisms) o Most common type in the US is the CTX-M, especially CTX-M-15 In institutions that do not perform ESBL testing, a lack of -
Activity of Aztreonam in Combination with Ceftazidime-Avibactam Against
Diagnostic Microbiology and Infectious Disease 99 (2021) 115227 Contents lists available at ScienceDirect Diagnostic Microbiology and Infectious Disease journal homepage: www.elsevier.com/locate/diagmicrobio Activity of aztreonam in combination with ceftazidime–avibactam against serine- and metallo-β-lactamase–producing ☆ ☆☆ ★ Pseudomonas aeruginosa , , Michelle Lee a, Taylor Abbey a, Mark Biagi b, Eric Wenzler a,⁎ a College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA b College of Pharmacy, University of Illinois at Chicago, Rockford, IL, USA article info abstract Article history: Existing data support the combination of aztreonam and ceftazidime–avibactam against serine-β-lactamase Received 29 June 2020 (SBL)– and metallo-β-lactamase (MBL)–producing Enterobacterales, although there is a paucity of data against Received in revised form 15 September 2020 SBL- and MBL-producing Pseudomonas aeruginosa. In this study, 5 SBL- and MBL-producing P. aeruginosa (1 Accepted 19 September 2020 IMP, 4 VIM) were evaluated against aztreonam and ceftazidime–avibactam alone and in combination via broth Available online xxxx microdilution and time-kill analyses. All 5 isolates were nonsusceptible to aztreonam, aztreonam–avibactam, – – Keywords: and ceftazidime avibactam. Combining aztreonam with ceftazidime avibactam at subinhibitory concentrations Metallo-β-lactamase produced synergy and restored bactericidal activity in 4/5 (80%) isolates tested. These results suggest that the VIM combination of aztreonam and ceftazidime–avibactam may be a viable treatment option against SBL- and IMP MBL-producing P. aeruginosa. Aztreonam © 2020 Elsevier Inc. All rights reserved. Ceftazidime–avibactam Synergy 1. Introduction of SBLs and MBLs harbored by P. aeruginosa are fundamentally different than those in Enterobacterales (Alm et al., 2015; Kazmierczak et al., The rapid global dissemination of Ambler class B metallo-β- 2016; Periasamy et al., 2020; Poirel et al., 2000; Watanabe et al., lactamase (MBL) enzymes along with their increasing diversity across 1991). -
FDA Drug Safety Communication: FDA Cautions About Dose Confusion and Medication Error with Antibacterial Drug Avycaz (Ceftazidime and Avibactam)
FDA Drug Safety Communication: FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam) Safety Announcement [09-22-2015] The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, we have revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram (see Photos). Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness. Since Avycaz’s approval in February 2015, we have received reports of three medication error cases related to confusion on how the strength was displayed on the Avycaz vial and carton labels. Two cases stated that the errors occurred during preparation of the dose in the pharmacy. The third case described concern about the potential for confusion because the strength displayed for Avycaz differs from how the strength is displayed for other beta-lactam/beta-lactamase antibacterial drugs. -
P1157 Searching for Optimal Treatment Regimens For
P1157 Searching for optimal treatment regimens for Stenotrophomonas maltophilia resistant to levofloxacin and/or sulfamethoxazole-trimethoprim: aztreonam in combination with avibactam or vaborbactam Mark Biagi*1, Samah Qasmieh1, Denise Lamm1, Kevin Meyer1, Tiffany Wu1, Eric Wenzler1 1 Pharmacy Practice, University of Illinois at Chicago, Chicago, United States Background: Current preferred treatment options for Stenotrophomonas maltophilia include sulfamethoxazole- trimethoprim and levofloxacin but their use may be compromised by increasing reports of resistance, toxicities, and drug interactions. Among the β-lactams, only aztreonam is able to evade S. maltophilia’s L1 metallo-β- lactamase-mediated hydrolysis but it remains prone to hydrolysis by the L2 serine β-lactamase, effectively rendering all β-lactams ineffective. Combining aztreonam with a β-lactamase inhibitor with activity against L2 may restore aztreonam’s activity and offer clinicians a novel treatment option. Materials/methods: MICs for 37 clinical S. maltophilia isolates resistant to levofloxacin and/or sulfamethoxazole- trimethoprim were tested in triplicate via broth microdilution method according to CLSI guidelines. Modal MICs are reported. Susceptibility interpretations were based on CLSI breakpoints for levofloxacin and sulfamethoxazole- trimethoprim against S. maltophilia and against Pseudomonas aeruginosa for aztreonam-based regimens. Time kill analyses were performed in triplicate for 5 isolates at standard inoculum (106) for aztreonam, aztreonam/avibactam, and aztreonam/vaborbactam at either fCmax or ¼, ½, 1, 2, or 4x MIC. Bactericidal activity was considered a ≥3 log10 reduction in CFU/mL from the starting inoculum. Synergy was ≥2 log10 reduction in CFU/mL compared to the most active agent alone. Results: Susceptibilities are summarized in Table 1. 97% (36/37) of isolates were resistant to aztreonam. -
12. What's Really New in Antibiotic Therapy Print
What’s really new in antibiotic therapy? Martin J. Hug Freiburg University Medical Center EAHP Academy Seminars 20-21 September 2019 Newsweek, May 24-31 2019 Disclosures There are no conflicts of interest to declare EAHP Academy Seminars 20-21 September 2019 Antiinfectives and Resistance EAHP Academy Seminars 20-21 September 2019 Resistance of Klebsiella pneumoniae to Pip.-Taz. olates) EAHP Academy Seminars 20-21 September 2019 https://resistancemap.cddep.org/AntibioticResistance.php Multiresistant Pseudomonas Aeruginosa Combined resistance against at least three different types of antibiotics, 2017 EAHP Academy Seminars 20-21 September 2019 https://atlas.ecdc.europa.eu/public/index.aspx Distribution of ESBL producing Enterobacteriaceae EAHP Academy Seminars 20-21 September 2019 Rossolini GM. Global threat of Gram-negative antimicrobial resistance. 27th ECCMID, Vienna, 2017, IS07 Priority Pathogens Defined by the World Health Organisation Critical Priority High Priority Medium Priority Acinetobacter baumanii Enterococcus faecium Streptococcus pneumoniae carbapenem-resistant vancomycin-resistant penicillin-non-susceptible Pseudomonas aeruginosa Helicobacter pylori Haemophilus influenzae carbapenem-resistant clarithromycin-resistant ampicillin-resistant Enterobacteriaceae Salmonella species Shigella species carbapenem-resistant fluoroquinolone-resistant fluoroquinolone-resistant Staphylococcus aureus vancomycin or methicillin -resistant Campylobacter species fluoroquinolone-resistant Neisseria gonorrhoae 3rd gen. cephalosporin-resistant -
Recarbrio, INN-Imipenem / Cilastatin / Relebactam
EMA/572792/2020 EMEA/H/C/004808 Recarbrio (imipenem / cilastatin / relebactam) An overview of Recarbrio and why it is authorised in the EU What is Recarbrio and what is it used for? Recarbrio is an antibiotic for treating adults with the following infections: • lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught while on a ventilator, which is a machine that helps a patient to breathe); • infection that has spread into the blood (bacteraemia) as a likely complication of hospital-acquired pneumonia or ventilator-associated pneumonia; • infections caused by bacteria classed as aerobic Gram-negative bacteria when other treatments might not work. Official guidance on the appropriate use of antibiotics should be considered when using the medicine. Recarbrio contains the active substances imipenem, cilastatin and relebactam. How is Recarbrio used? Recarbrio can only be obtained with a prescription and it should be used only after consulting a doctor with experience of managing infectious diseases. Recarbrio is given by infusion (drip) into a vein over 30 minutes. It is given every 6 hours for 5 to 14 days, depending on the nature of the infection. For more information about using Recarbrio, see the package leaflet or contact your doctor or pharmacist. How does Recarbrio work? One of the active substances in Recarbrio, imipenem, kills bacteria and the other two, cilastatin and relebactam, increase imipenem’s effectiveness in different ways. Imipenem interferes with bacterial proteins that are important for building the bacterial cell wall. This results in defective cell walls that collapse and cause the bacteria to die. -
Regional Hospitals Antimicrobial Susceptibilities of Major Pathogens
Comparative Daily Costs for Commonly used Comparative Daily Costs for Commonly Commonly used INTRAVENOUS INTRAVENOUS used ORAL Antibiotics* Antibiotics* Antibiotics* Daily Med Daily Med Intravenous Antibiotics Normal Dose Cost ($) Oral Antibiotics Normal Dose Cost ($) P.O. Box 342 NOTES: Pencillins Penicillins Ampicillin 1 gm q 6h 5.68 Amoxicillin 500 mg tid 0.24 This report summarizes routinely tested antibiotics. Minneapolis, MN 55440-0342 Ampicillin/Sulbactam 3 gm q 6h 14.73 Amoxicillin/Clavulanate 500 mg tid 0.90 Actual patient reports may selectively exclude some 612-863-4678 Nafcillin 1 gm q 4h 19.02 Dicloxacillin 500 mg qid 2.84 susceptibility results. Penicillin G 5 MU q 4h 45.18 Penicillin VK 500 mg qid 0.75 Piperacillin/Tazobactam 3.375 gm q8h 6.54 Cephalosporins 2020 Cephalosporins Cefadroxil 500 mg bid 0.71 Cefazolin 1 gm q 8h 1.98 Cefdinir 300 mg bid 2.64 Regional Hospitals Cefepime 1 gm q 8h 12.94 Cefuroxime axetil 250 mg bid 2.90 Antimicrobial Susceptibilities Ceftazidime 1 gm q 8h 9.05 Cephalexin 500 mg qid 0.30 Ceftazidime/avibactam 2.5 gm q 8h 1075.89 Anaerobic of Major Pathogens Cefoxitin 1 gm q 6h 11.18 Clindamycin 450 mg tid 1.80 Ceftaroline 600 mg q12h 315.62 Metronidazole 500 mg tid 0.46 Data is also located on the Allina Knowledge Network (AKN): Ceftolozane-tazobactam 1.5 gm q 8h 349.83 Miscellaneous Cefriaxone 1 gm q 24h 1.20 Acyclovir 200 mg 5x/d 0.55 http://labs.allinahealth.org/Lab/Linkview?Sublink=susceptdata Cefuroxime 1.5 gm q 8h 11.16 Atovaquone 1500 mg daily 40.38 Carbapenems Azithromycin 250 mg daily 0.66 Ertapenem 1 gm q 24h 54.86 Ciprofloxacin 500 mg bid 0.26 The intent of this card is to provide a preliminary guide to Imipenem 500 mg q 8h 29.82 Clarithromycin 500 mg bid 1.55 susceptibilities. -
New Β-Lactamase Inhibitor Combinations: Options for Treatment; Challenges for Testing
MEDICAL/SCIENTIFIC AffAIRS BULLETIN New β-lactamase Inhibitor Combinations: Options for Treatment; Challenges for Testing Background The β-lactam class of antimicrobial agents has played a crucial role in the treatment of infectious diseases since the discovery of penicillin, but β–lactamases (enzymes produced by the bacteria that can hydrolyze the β-lactam core of the antibiotic) have provided an ever expanding threat to their successful use. Over a thousand β-lactamases have been described. They can be divided into classes based on their molecular structure (Classes A, B, C and D) or their function (e.g., penicillinase, oxacillinase, extended-spectrum activity, or carbapenemase activity).1 While the first approach to addressing the problem ofβ -lactamases was to develop β-lactamase stable β-lactam antibiotics, such as extended-spectrum cephalosporins, another strategy that has emerged is to combine existing β-lactam antibiotics with β-lactamase inhibitors. Key β-lactam/β-lactamase inhibitor combinations that have been used widely for over a decade include amoxicillin/clavulanic acid, ampicillin/sulbactam, and pipercillin/tazobactam. The continued use of β-lactams has been threatened by the emergence and spread of extended-spectrum β-lactamases (ESBLs) and more recently by carbapenemases. The global spread of carbapenemase-producing organisms (CPOs) including Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii, limits the use of all β-lactam agents, including extended-spectrum cephalosporins (e.g., cefotaxime, ceftriaxone, and ceftazidime) and the carbapenems (doripenem, ertapenem, imipenem, and meropenem). This has led to international concern and calls to action, including encouraging the development of new antimicrobial agents, enhancing infection prevention, and strengthening surveillance systems. -
AMEG Categorisation of Antibiotics
12 December 2019 EMA/CVMP/CHMP/682198/2017 Committee for Medicinal Products for Veterinary use (CVMP) Committee for Medicinal Products for Human Use (CHMP) Categorisation of antibiotics in the European Union Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 29 October 2018 Adopted by the CVMP for release for consultation 24 January 2019 Adopted by the CHMP for release for consultation 31 January 2019 Start of public consultation 5 February 2019 End of consultation (deadline for comments) 30 April 2019 Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 19 November 2019 Adopted by the CVMP 5 December 2019 Adopted by the CHMP 12 December 2019 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Categorisation of antibiotics in the European Union Table of Contents 1. Summary assessment and recommendations .......................................... 3 2. Introduction ............................................................................................ 7 2.1. Background ........................................................................................................ -
Idweek16 CAZ-AVI PSA 1831.Pdf
Helio S. Sader, MD, PhD IDWEEK 2016 Antimicrobial Activity of Ceftazidime-Avibactam Tested Against Pseudomonas aeruginosa Isolates from JMI Laboratories 1831 North Liberty, IA, USA USA Hospitals Stratified by Site of Infection: Results from the INFORM Surveillance Program, 2013-2015 www.jmilabs.com HS SADER, M CASTANHEIRA, MD HUBAND, RK FLAMM ph. 319.665.3370 fax 319.665.3371 JMI Laboratories, North Liberty, Iowa, USA [email protected] Ceftazidime-avibactam is a combination agent consisting of the non-β- Table 1. Activity of ceftazidime-avibactam and comparator antimicrobial Figure 2. Antimicrobial activity of ceftazidime-avibactam, ceftazidime, Abstract lactam β-lactamase inhibitor avibactam and the broad-spectrum Results agents when tested against Pseudomonas aeruginosa from USA meropenem, and piperacillin-tazobactam when tested against P. aeruginosa cephalosporin, ceftazidime. Avibactam is a member of the hospitals (2013-2015). and stratified by site of infection. Background: Ceftazidime (CAZ)-avibactam (AVI) was approved by the United • Isolates were mostly from pneumonia (n=2,903; 52.9%), skin and skin diazabicyclooctanes (DBOs), a novel class of non-β-lactam β-lactamase MIC MIC CLSIa States Food and Drug Administration (US-FDA) for treatment of complicated intra- structure (SSSI; 1,286; 23.4%), bloodstream (BSI; 436; 7.9%), urinary Antimicrobial Agent 50 90 abdominal and urinary tract infections in 2015 and is under clinical development inhibitors which has a different mechanism of action when compared with (μg/mL) %S %I %R 100 tract (UTI; 417; 7.6%) and intra-abdominal infections (IAI; 199; 3.6%). All isolates (5,486) 90 for treatment of hospital-acquired pneumonia. -
Consideration of Antibacterial Medicines As Part Of
Consideration of antibacterial medicines as part of the revisions to 2019 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) Section 6.2 Antibacterials including Access, Watch and Reserve Lists of antibiotics This summary has been prepared by the Health Technologies and Pharmaceuticals (HTP) programme at the WHO Regional Office for Europe. It is intended to communicate changes to the 2019 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) to national counterparts involved in the evidence-based selection of medicines for inclusion in national essential medicines lists (NEMLs), lists of medicines for inclusion in reimbursement programs, and medicine formularies for use in primary, secondary and tertiary care. This document does not replace the full report of the WHO Expert Committee on Selection and Use of Essential Medicines (see The selection and use of essential medicines: report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2019 (including the 21st WHO Model List of Essential Medicines and the 7th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1021). Licence: CC BY-NC-SA 3.0 IGO: https://apps.who.int/iris/bitstream/handle/10665/330668/9789241210300-eng.pdf?ua=1) and Corrigenda (March 2020) – TRS1021 (https://www.who.int/medicines/publications/essentialmedicines/TRS1021_corrigenda_March2020. pdf?ua=1). Executive summary of the report: https://apps.who.int/iris/bitstream/handle/10665/325773/WHO- MVP-EMP-IAU-2019.05-eng.pdf?ua=1.