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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. -
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 -
Burkholderia Pseudomallei Clinical Isolates Are Highly Susceptible in Vitro To
bioRxiv preprint doi: https://doi.org/10.1101/2020.03.26.009134; this version posted March 27, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY-NC 4.0 International license. 1 Burkholderia pseudomallei clinical isolates are highly susceptible in vitro to 2 cefiderocol, a novel siderophore cephalosporin 3 Delaney Burnard1,6, Gemma Robertson1,2,4, Andrew Henderson1,5, Caitlin Falconer1, Michelle 4 Bauer-Leo1, Kyra Cottrell1, Ian Gassiep2,3, Robert Norton8,9, David L. Paterson1,3, Patrick N. 5 A. Harris1,2* 6 7 1University of Queensland Centre for Clinical Research, Herston, Queensland, Australia 8 2Pathology Queensland, Queensland Health, Herston, Queensland, Australia 9 3Royal Brisbane and Women’s Hospital, Queensland Health, Herston, Queensland, Australia 10 4Forensic and Scientific Services, Queensland Health, Coopers Plains, Queensland, Australia 11 5Princess Alexandra Hospital, Queensland Health, Woolloongabba, Queensland, Australia 12 6Genecology Research Centre, University of the Sunshine Coast, Sippy Downs, Queensland, Australia 13 8Townsville Hospital and Health Service, Townsville, Queensland, Australia 14 9School of Medicine, James cook university, Townsville, Queensland, Australia 15 16 *Corresponding author: [email protected] 17 University of Queensland, Faculty of Medicine, UQ Centre for Clinical Research, Royal Brisbane & Women’s 18 Hospital, Herston, QLD, 4029, Australia 19 20 Running title: B. pseudomallei in vitro susceptibility to cefiderocol 21 Keywords: melioidosis, Burkholderia pseudomallei, cefiderocol, antimicrobial resistance, 22 AMR, minimum inhibitory concentration, MIC 1 bioRxiv preprint doi: https://doi.org/10.1101/2020.03.26.009134; this version posted March 27, 2020. -
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. -
Antimicrobial Activity of Ceftaroline Combined with Avibactam Tested Against Contemporary (2012) Helio S
Antimicrobial Activity of Ceftaroline Combined with Avibactam Tested Against Contemporary (2012) Helio S. Sader, MD, PhD JMI Laboratories Bacteria Collected from USA Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) North Liberty, IA, USA ECCMID 2013 www.jmilabs.com HS SADER, RK FLAMM, RN JONES ph. 319.665.3370 P1620 fax 319.665.3371 JMI Laboratories, North Liberty, Iowa, USA [email protected] Table 2. Antimicrobial activities of ceftaroline-avibactam, ceftaroline and comparator agents when tested against gram-negative organisms from Abstract Introduction Results skin and skin structure infections (USA, 2012). Conclusions Objective: To evaluate the activity of ceftaroline Ceftaroline, the active metabolite of the prodrug ceftaroline • The most common organisms were S. aureus (3,481; Organism (no tested)/ MIC (mg/L) %S / %I / %R • Ceftaroline-avibactam was highly active antimicrobial agent 50% 90% Range CLSIa EUCASTa (CPT)-avibactam (AVI) tested against bacteria from fosamil, is a cephalosporin with notable in vitro bactericidal 50.5% MRSA), E. coli (444; 13.3% ESBL-phenotype), β- E. coli (444) against ESBL-phenotype and carbapenem- ABSSSI collected in USA hospitals in 2012. CPT activity against organisms commonly responsible for haemolytic streptococci (βHS; 389) and Klebsiella spp. Ceftaroline-avibactam 0.03 0.06 ≤0.015 – 0.5 - / - / - - / - / - non-susceptible Enterobacteriaceae Ceftaroline 0.12 32 ≤0.015 – >32 83.3 / 2.7 / 14.0 83.3 / 0.0 / 16.7 fosamil is a novel parenteral cephalosporin community-acquired -
209445Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209445Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review Clinical Microbiology/Virology Multi-Disciplinary Review and Evaluation NDA 209445 FETROJA (cefiderocol) for Injection NDA Multi-Disciplinary Review and Evaluation Application Type 505(b)(1) NDA Type 1 NME Application Number(s) NDA 209445 Priority or Standard Priority Submit Date(s) December 14, 2018 Received Date(s) December 14, 2018 PDUFA Goal Date November 14, 2019 Division/Office Division of Anti-Infectives/Office of Infectious Diseases Review Completion Date See DARRTS electronic signature page Established/Proper Name Cefiderocol (Proposed) Trade Name FETROJA Pharmacologic Class Cephalosporin Code Names S-649266; RSC-649266; GSK2696266 Applicant Shionogi USA, Inc. Dosage Form Lyophilized powder for Injection, 1 gram per vial Dosing Regimen Cefiderocol 2 gm intravenous infusion every 8 hours for 7-14 days Applicant Proposed Treatment of complicated urinary tract infections (cUTI), including Indication/Population pyelonephritis, due to Gram-negative bacteria in patients with limited or no alternative treatment options Regulatory Action Approval Recommended Treatment of cUTI, including pyelonephritis, due to susceptible Indication(s)/Population(s) Gram-negative bacteria in patients 18 years of age or older with limited or no alternative treatment options 1 Reference ID: 4520111 Multi-Disciplinary -
FDA Briefing Document Meeting of The
FDA Briefing Document Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC) October 16, 2019 Cefiderocol Injection Applicant: Shionogi, Inc. Proposed Indication: The treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to Gram-negative bacteria in patients with limited or no alternative treatment options 1 DISCLAIMER STATEMENT: The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought cefiderocol to this Advisory Committee in order to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the Advisory Committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting. 2 Table of Contents 1 Introduction ................................................................................................................ -
Successful Treatment of Ventriculitis Caused by MDR/XDR Gram-Negative Bacillus Using Ceftazidime/Avibactam: Case Series and Literature Review
Infection and Drug Resistance Dovepress open access to scientific and medical research Open Access Full Text Article CASE SERIES Successful Treatment of Ventriculitis Caused by MDR/XDR Gram-Negative Bacillus Using Ceftazidime/Avibactam: Case Series and Literature Review Qian Zhou1 Background: Central nervous system (CNS) infections caused by multidrug-resistant Hao Wang2 (MDR) and extensively drug-resistant (XDR) Gram-negative bacillus, including carbape Tianxiang Zhan2 nem-resistant Enterobacteriaceae (CRE) and Pseudomonas aeruginosa, are associated with Xiaofeng Yang1,2 high mortality rates. Clinical trials of ceftazidime/avibactam (CAZ/AVI) on infections of Liang Wen2 other systems indicate that they are effective against these infections. However, clinical studies on the efficacies of CAZ/AVI in the treatment of CNS infections have not been done. 1 Department of Emergency and Trauma Case Presentation: We evaluated 3 patients diagnosed with MDR/XDR Gram-negative Center, The International Medical Center, The First Affiliated Hospital, bacillus-associated CNS infections, and effectively treated with CAZ/AVI. Moreover, we Zhejiang University School of Medicine, performed literature reviews. Before the onset of CNS infections, the 3 patients were Hangzhou, Zhejiang Province, 310003, subjected to neurosurgical operations, treated with mechanical ventilation, long-term inten People’s Republic of China; 2Department of Neurosurgery, The First Affiliated sive care unit therapy, and various antibiotics. By intravenously administering CAZ/AVI, Hospital, Zhejiang University School of combined with another antibiotic, the MDR/XDR K. pneumoniae and P. aeruginosa asso Medicine, Hangzhou, Zhejiang Province, 310003, People’s Republic of China ciated ventriculitis was effectively treated in the 3 patients. Conclusion: CAZ/AVI is a viable treatment option for CNS infections caused by MDR/ XDR Gram-negative bacteria. -
CLSI AST News Update Janet A
Volume 3, Issue 2 Spring 2018 CLSI Subcommittee on Antimicrobial Susceptibility Testing CLSI AST News Update Janet A. Hindler, MCLS MT(ASCP) F(AAM), Editor Audrey N. Schuetz, MD, MPH, D(ABMM), Editor The CLSI Outreach Working Group (ORWG) is providing this Newsletter to highlight some recent issues related to antimicrobial susceptibility testing Inside This Issue: and reporting. We are listing links to some new educational materials and reminding you where you can find information about the CLSI AST Featured Article: Part 1 Subcommittee proceedings. New β-lactam combination agents for the treatment of Gram-negative bacterial infections: what the clinical microbiologist needs to know! ..................................................4 Upcoming Webinar: Featured Article: Part 2 Why all the fuss over quality control of Preparation, Presentation, and Promotion of Cumulative Antibiograms To β-lactam combination agents? ........................8 Support Antimicrobial Stewardship Programs Case Study: Cefazolin, Urine, and October 16, 2018 | 1:00–2:00 PM Eastern (US) Time Escherichia coli, Klebsiella pneumoniae, and Presenters: Proteus mirabilis: Entertaining Solutions Sharon Erdman, PharmD for Antimicrobial Susceptibility Testing and Clinical Professor, Purdue University College of Pharmacy Reporting ..........................................................12 Infectious Diseases Clinical Pharmacist/Co-Director OPAT Program, Eskenazi Health Burning Question: What Should Clinical Laboratorians Know About Gonorrhea in Patricia J. Simner, PhD, D(ABMM) 2018? ................................................................15 Associate Professor of Pathology, Johns Hopkins University Director of Medical Bacteriology and Parasitology Laboratories, Johns Hopkins Hot Topic: It’s Enough to mec You Crazy! ...18 Hospital What does the CLSI AST Subcommittee do? The first edition of the CLSI AST News Update (Vol 1, Issue 1, Spring 2016) described details about the organization and operation of the CLSI AST Subcommittee. -
Novel Cephalosporins in Septic Subjects and Severe Infections: Present Findings and Future Perspective
PERSPECTIVE published: 07 May 2021 doi: 10.3389/fmed.2021.617378 Novel Cephalosporins in Septic Subjects and Severe Infections: Present Findings and Future Perspective Silvia Corcione 1,2†, Tommaso Lupia 1*† and Francesco Giuseppe De Rosa 1 1 Department of Medical Sciences, Infectious Diseases, University of Turin, Turin, Italy, 2 Tufts University School of Medicine, Boston, MA, United States In past decade, cephalosporins have developed significantly, and data regarding novel cephalosporins (i.e., ceftobiprole, ceftaroline, ceftolozane/tazobactam, ceftazidime/avibactam, and cefiderocol) within septic and bacteremic subjects are rising. These compounds generally offer very promising in vitro microbiological susceptibility, Edited by: although the variability among gram-negative and -positive strains of different cohorts is Alessandro Russo, noticed in the literature. We require further pharmacological data to measure the best University of Pisa, Italy dose in order to prevent sub-therapeutic drug levels in critically ill patients. These new Reviewed by: compounds in theory are the sparing solution in the Enterobacteriales infection group Filippo Del Puente, Ente Ospedaliero Ospedali for different antimicrobial classes such as aminoglycosides notably within endovascular Galliera, Italy and GNB-bacteremias, as well as colistin and carbapenem-sparing strategies, favoring Roger M. Echols, Infectious Disease Drug Development good safety profile molecules. Moreover, new cephalosporins are the basis for the actual Consulting, LLC, United States indications to open up new and exciting prospects for serious infections in the future. *Correspondence: In future, patients will be addressed with the desirable approach to sepsis and serious Tommaso Lupia infections in terms of their clinical situation, inherent features of the host, the sensitivity [email protected] profile, and local epidemiology, for which evidence of the use of new cephalosporin in † These authors have contributed the treatment of severe infections will fill the remaining gaps. -
Antibacterial Prodrugs to Overcome Bacterial Resistance
molecules Review Antibacterial Prodrugs to Overcome Bacterial Resistance Buthaina Jubeh , Zeinab Breijyeh and Rafik Karaman * Pharmaceutical Sciences Department, Faculty of Pharmacy, Al-Quds University, Jerusalem P.O. Box 20002, Palestine; [email protected] (B.J.); [email protected] (Z.B.) * Correspondence: [email protected] or rkaraman@staff.alquds.edu Academic Editor: Helen Osborn Received: 10 March 2020; Accepted: 26 March 2020; Published: 28 March 2020 Abstract: Bacterial resistance to present antibiotics is emerging at a high pace that makes the development of new treatments a must. At the same time, the development of novel antibiotics for resistant bacteria is a slow-paced process. Amid the massive need for new drug treatments to combat resistance, time and effort preserving approaches, like the prodrug approach, are most needed. Prodrugs are pharmacologically inactive entities of active drugs that undergo biotransformation before eliciting their pharmacological effects. A prodrug strategy can be used to revive drugs discarded due to a lack of appropriate pharmacokinetic and drug-like properties, or high host toxicity. A special advantage of the use of the prodrug approach in the era of bacterial resistance is targeting resistant bacteria by developing prodrugs that require bacterium-specific enzymes to release the active drug. In this article, we review the up-to-date implementation of prodrugs to develop medications that are active against drug-resistant bacteria. Keywords: prodrugs; biotransformation; targeting; β-lactam antibiotics; β-lactamases; pathogens; resistance 1. Introduction Nowadays, the issue of pathogens resistant to drugs and the urgent need for new compounds that are capable of eradicating these pathogens are well known and understood.