Ad Hoc Working Group to Reassess Daptomycin Breakpoint for Enterococci
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1072 ICAAC Fritschen MW08 F
POSTER E-0115 Thomas R. Fritsche, MD, PhD In-vitro Activity of Ceftobiprole Tested Against a Recent Collection of JMI Laboratories ICAAC 2006 345 Beaver Kreek Centre, Suite A North American Pseudomonas aeruginosa North Liberty, IA 52317 Tel: (319) 665-3370 T.R. Fritsche, H.S. Sader, R.N. Jones • JMI Laboratories, North Liberty, Iowa, USA Fax: (319) 665-3371 e-mail: [email protected] Introduction Results Updated Abstract Table 1. In-vitro activity of ceftobiprole in comparison to selected antimicrobial agents tested against 221 isolates of P. aeruginosa Ceftobiprole (previously known as BAL9141), is an investigational broad- (North America) • P. aeruginosa isolates recovered from patients in North America generally Background: Ceftobiprole (BAL9141; BPR) is an investigational spectrum cephalosporin with potent activity against both Gram-negative and displayed less antibiotic resistance than did isolates from the all-isolate Antimicrobial agent MIC (µg/ml) MIC (µg/ml) Range (µg/ml) % Susceptible/resistanta cephalosporin with a broad spectrum of activity including methicillin- Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus 50 90 worldwide collection (examples: tobramycin, 3.6 and 20.8% resistance, resistant S. aureus. PK/PD characteristics of the parenteral prodrug (MRSA) (3, 7-9). The agent is stable to many β-lactamases and has a Ceftobiprole 2 >8 ≤0.06 – >8 - / - respectively; imipenem, 5.9 and 11.6%; Tables 1 and 2). formulation are consistent with usable potencies against streptococci, Ceftazidime 2 >16 ≤1 – >16 78.7 / 15.8 strong affinity for penicillin binding proteins (PBPs), including PBP2a, which • Ceftobiprole was as active as ceftazidime and cefepime (MIC , 2 µg/ml) E. -
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 -
Possible Clinical Indications of Ceftobiprole
©The Author 2019. Published by Sociedad Española de Quimioterapia. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)(https://creativecommons.org/licenses/by-nc/4.0/). Ceftobiprole review José Barberán Possible clinical indications of ceftobiprole Servicio de Medicina Interna - Enfermedades infecciosas, Hospital Universitario HM Montepríncipe, Universidad San Pablo CEU. Madrid, Spain ABSTRACT demonstrated in vitro activity on the majority of Gram-positive cocci and aerobic Gram-negative bacilli of clinical relevance. Ceftobiprole is a fifth-generation cephalosporin approved On the former, it has heightened bactericidal action and in- for the treatment of adult community-acquired pneumonia cludes: 1) Staphylococcus spp., both methicillin- and vancomy- and non-ventilator associated hospital-acquired pneumonia. cin-resistant Staphylococcus aureus and coagulase-negative However, its microbiological and pharmacokinetic profile is staphylococci, 2) Streptococcus spp., including Streptococ- very attractive as armamentarium for empirical monotherapy cus pneumoniae resistant to penicillins and third-generation treatment in other infections too. Among these, the following cephalosporins, and 3) Enterococcus faecalis, as it is the first scenarios could be considered complicated skin and soft tissue and only cephalosporin here with demonstrated activity. With infections, moderate-severe diabetic foot infections without regard to Gram-negative bacilli, its spectrum includes -
Demoscene Outreach Tour
together with Gargaj from Conspiracy and Steeler from DKEV/ THE MAN FROM THE AUDIENCE Breakpoint organizing, who where hosting screenings and talks I was handing out DVDs after the show when I quickly checked of their own. ›DEMOSCENE my bag and seeing that I was seriously quickly nearing the end OUTREACH TOUR: of my supply, I realized that it would be stupid of me to run out The previous year, Knos (also of Scene.org fame) and I had worked of discs on the second day of a five-day conference. I covered THE FULL STORY together to produce a DVD that we could hand out to the partici- the remaining few discs and started telling people around me pants of the screening. This DVD contained most of the nominated (PART 1)‹ that I unfortunately was out of discs. A little nasty perhaps, but I BY GLOOM OF EXCESS productions and a simple DVD menu-structure that allowed the would need them during one-on-one outreach meet-ups later on. viewer to quickly watch video-captured versions of the demos. At Suddenly a guy approached me from the back of the now thin- FMX/06, I had run out of these DVDs moments after the screening, ning crowd of people. “Do you have one for me as well?” he said. because everyone wanted a copy, so in 2007 I made sure to burn “Okay then,” I thought, and handed him a DVD. “Thanks for this” By now, most of you are probably aware of the demoscene out- twice as many copies. -
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. -
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of people who got together through Bulletin Board Systems, THE PORTUGUESE DEMOSCENE Reckless Life BBS and Infinity BBS run by the infamous Captain Hook. The scene thrived through the nineties with the uprising HISTORY of IRC and the two issues of the diskmag, Infinity, put together BY PS OF TPOLM by Garfield, VAngel and Spellcaster if my memory serves me correctly. The first documented demoscene event in Portugal The Portuguese demoscene, as most Portuguese technology, ducing cheap labour for English-owned factories of the ZX Sin- was organized in 1996 and was called the Virtual Music Con- is a fluke of chance. For many years, Portugal held last place clair Spectrum family of machines. While kids in Central and test. It was just a simple tracking competition. Groups formed among Europe’s nations in iliteracy per capita and emigration. Northern Europe were playing with their Commodores and around this time were Radioactive Design (RD) with Garfield, Certified higher education for new technologies and arts has Ataris during the late eighties, in Portugal we were consuming only been institutionalized within the last 10 years. Even large Spectrum magnetic tapes. WHILE KIDS IN CENTRAL volume capitalist markets, such as the videogame industry, AND NORTHERN EUROPE are still in their infancy in Portugal. It has only been six years, THE BIRTH OF THE PORTUGUESE at most, since serious full time jobs became available in the WERE PLAYING WITH THEIR business. In fact Portugal is a country that mostly imports and DEMOSCENE COMMODORES AND ATARIS, IN consumes technology (2.5 cellphones per person on average) The first known demo made by a Portuguese demoscener was PORTUGAL WE WERE CONSUMING instead of developing and exporting it. -
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. -
Camila Schafer
UNIVERSIDADE DO VALE DO RIO DOS SINOS (UNISINOS) PROGRAMA DE PÓS-GRADUAÇÃO EM CIÊNCIAS DA COMUNICAÇÃO (PPGCC) NÍVEL MESTRADO CAMILA SCHÄFER ENTRE O NOVO E O OBSOLETO: MEMÓRIA, RASTROS E AURA DO HARDWARE NA CHIPMUSIC SÃO LEOPOLDO Março de 2014 Camila Schäfer ENTRE O NOVO E O OBSOLETO: MEMÓRIA, RASTROS E AURA DO HARDWARE NA CHIPMUSIC Dissertação apresentada como requisito parcial para a obtenção do título de Mestre , pelo Programa de Pós- Graduação em Ciências da Comunicação da Universidade do Vale do Rio dos Sinos – UNISINOS. Área de concentração: Processos Midiáticos. Linha de Pesquisa: Mídias e Processos Audiovisuais. Orientador: Profª. Drª. Suzana Kilpp São Leopoldo Março de 2014 S296e Schäfer, Camila Entre o novo e o obsoleto: memória, rastros e aura do hardware na Chipmusic/ por Camila Schäfer. -- São Leopoldo, 2014. 136 f.: il. color; 30 cm. Dissertação (mestrado) – Universidade do Vale do Rio dos Sinos, Programa de Pós-Graduação em Ciências da Comunicação, São Leopoldo, RS, 2014. Área de concentração: Processos midiáticos. Linha de Pesquisa: Mídias e processos audiovisuais. Orientação: Profª. Drª. Suzana Kilpp, Escola da Indústria Criativa. 1.Videogames – Sonoplastia. 2.Jogos eletrônicos – Sonoplastia. 3.Som – Registro e reprodução – Técnicas digitais. 4.Computador – Música. 5.Hardware. I.Kilpp, Suzana. II.Título. CDU 004:794 004.4'277.4:794 Catalogação na publicação: Bibliotecária Carla Maria Goulart de Moraes – CRB 10/1252 AGRADECIMENTOS Como a maioria dos textos de agradecimento, inicio este reafirmando o que muitos outros já disseram: nenhuma pesquisa se constrói sozinha, assim como nenhum pesquisador realiza seu trabalho e se desenvolve sem a contribuição de outras pessoas. -
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 -
Computer Demos—What Makes Them Tick?
AALTO UNIVERSITY School of Science and Technology Faculty of Information and Natural Sciences Department of Media Technology Markku Reunanen Computer Demos—What Makes Them Tick? Licentiate Thesis Helsinki, April 23, 2010 Supervisor: Professor Tapio Takala AALTO UNIVERSITY ABSTRACT OF LICENTIATE THESIS School of Science and Technology Faculty of Information and Natural Sciences Department of Media Technology Author Date Markku Reunanen April 23, 2010 Pages 134 Title of thesis Computer Demos—What Makes Them Tick? Professorship Professorship code Contents Production T013Z Supervisor Professor Tapio Takala Instructor - This licentiate thesis deals with a worldwide community of hobbyists called the demoscene. The activities of the community in question revolve around real-time multimedia demonstrations known as demos. The historical frame of the study spans from the late 1970s, and the advent of affordable home computers, up to 2009. So far little academic research has been conducted on the topic and the number of other publications is almost equally low. The work done by other researchers is discussed and additional connections are made to other related fields of study such as computer history and media research. The material of the study consists principally of demos, contemporary disk magazines and online sources such as community websites and archives. A general overview of the demoscene and its practices is provided to the reader as a foundation for understanding the more in-depth topics. One chapter is dedicated to the analysis of the artifacts produced by the community and another to the discussion of the computer hardware in relation to the creative aspirations of the community members. -
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 ................................................................................................................ -
A Thesis Entitled an Oral Dosage Form of Ceftriaxone Sodium Using Enteric
A Thesis entitled An oral dosage form of ceftriaxone sodium using enteric coated sustained release calcium alginate beads by Darshan Lalwani Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences with Industrial Pharmacy Option _________________________________________ Jerry Nesamony, Ph.D., Committee Chair _________________________________________ Sai Hanuman Sagar Boddu, Ph.D, Committee Member _________________________________________ Youssef Sari, Ph.D., Committee Member _________________________________________ Patricia R. Komuniecki, PhD, Dean College of Graduate Studies The University of Toledo May 2015 Copyright 2015, Darshan Narendra Lalwani This document is copyrighted material. Under copyright law, no parts of this document may be reproduced without the expressed permission of the author. An Abstract of An oral dosage form of ceftriaxone sodium using enteric coated sustained release calcium alginate beads by Darshan Lalwani Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences with Industrial Pharmacy option The University of Toledo May 2015 Purpose: Ceftriaxone (CTZ) is a broad spectrum semisynthetic, third generation cephalosporin antibiotic. It is an acid labile drug belonging to class III of biopharmaceutical classification system (BCS). It can be solvated quickly but suffers from the drawback of poor oral bioavailability owing to its limited permeability through