DOCSLIB.ORG

Target Product Profiles for Needed Antibacterial Agents

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

TARGET PRODUCT PROFILES FOR NEEDED ANTIBACTERIAL AGENTS: enteric fever, gonorrhoea, neonatal sepsis, urinary tract infections and meeting report TARGET PRODUCT PROFILES FOR NEEDED ANTIBACTERIAL AGENTS: enteric fever, gonorrhoea, neonatal sepsis, urinary tract infections and meeting report TARGET PRODUCT PROFILES FOR NEEDED ANTIBACTERIAL AGENTS: enteric fever, gonorrhoea, neonatal sepsis, urinary tract infections and meeting report Target product profiles for needed antibacterial agents: enteric fever, gonorrhoea, neonatal sepsis, urinary tract infections and meeting report ISBN 978-92-4-000389-7 (electronic version) ISBN 978-92-4-000390-3 (print version) © World Health Organization 2020 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/ by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Target product profiles for needed antibacterial agents: enteric fever, gonorrhoea, neonatal sepsis, urinary tract infections and meeting report. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/ licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Printed in Switzerland. Contents Acknowledgements iv Financial support iv EXPERT MEETING ON TARGET PRODUCT PROFILES FOR NEEDED ANTIBACTERIAL AGENTS 1 1 3–4 OCTOBER 2019, GENEVA, SWITZERLAND, MEETING REPORT Introduction 1 The TPP development process 2 Summary of the meeting proceedings 3 Summary of discussions 3 Conclusion 5 2 TARGET PRODUCT PROFILE FOR THERAPY OF UNCOMPLICATED ENTERIC FEVER 7 Introduction 7 Disease burden 7 Antibiotic resistance 7 Available treatment options 7 Therapies in development 7 Purpose of the TPP 8 Access and affordability 8 TPP for therapy of uncomplicated enteric fever 9 3 TARGET PRODUCT PROFILE FOR THERAPY OF DIAGNOSED UNCOMPLICATED GONORRHOEA 11 Introduction 11 Disease burden 11 Antibiotic resistance 11 Available treatment options 11 Therapies in development 12 Purpose of the TPP 12 Access and affordability 12 TPP for therapy of diagnosed uncomplicated gonorrhoea 13 4 TARGET PRODUCT PROFILE FOR THERAPY OF NEONATAL SEPSIS IN HIGH RESISTANCE SETTINGS 15 Introduction 15 Disease burden 15 Antibiotic resistance 15 Available treatment options 15 Therapies in development 16 Purpose of the TPP 16 Access and affordability 16 TPP for therapy in children including neonates with MDR Gram-negative infections 17 5 TARGET PRODUCT PROFILES FOR ORAL THERAPY OF URINARY TRACT INFECTIONS 19 Introduction 19 Disease burden 19 Antibiotic resistance 19 Available treatment options 19 Therapies in development 20 Purpose of the TPPs 20 Access and affordability 20 TPP for oral therapy of acute uncomplicated UTI (cystitis) 22 TPP for oral therapy of acute pyelonephritis 23 TARGET PRODUCT PROFILES FOR NEEDED ANTIBACTERIAL AGENTS iii Acknowledgements The project was led by Ingrid Smith (WHO/ STI Programmes; and Maternal, Newborn, Child & Department of Global Coordination and Partnership Adolescent Health and Ageing for their input and (GCP)/Antimicrobial Resistance (AMR)), under the active participation throughout the process. WHO supervision of Peter Beyer (WHO/GCP/AMR). Ursula would also like to thank all the experts in the scientific Theuretzbacher (WHO consultant and Center for advisory group as well as all external organizations Anti-Infective Agents, Austria) was the leading and individuals who provided comments on the scientific expert and prepared the scoping and draft scoping documents and feedback on the draft TPP documents. GCP would like to thank experts TPP documents during the public consultation. In from the following WHO Departments – Health compliance with WHO transparency procedures, the Products, Policy and Standards; Immunization, feedback received during the public consultation on Vaccines and Biologicals; Global HIV, Hepatitis and the TPP documents was made publicly available. Financial support Funding for this project was kindly provided by GARDP and by the Governments of Germany and Norway. iv TARGET PRODUCT PROFILES FOR NEEDED ANTIBACTERIAL AGENTS Expert meeting on target product profiles for needed antibacterial agents 3–4 October 2019, Geneva, Switzerland Meeting report Introduction This is the report of the scientific advisory group clinical development in 2017, and the report meeting on the development of target product Antibacterial agents in preclinical development profiles (TPPs) for needed antibacterial agents for in 2019, to provide evidence-based guidance and enteric fever (typhoid fever), gonorrhoea, neonatal a public health perspective in developing new sepsis and urinary tract infections, that took place antibacterial therapies.2,3 in Geneva, Switzerland, on 3–4 October 2019. WHO has subsequently formulated TPPs to meet Antimicrobial resistance (AMR) has increased the need for specific antibacterial agents. TPPs worldwide in recent decades, limiting treatment are used by drug developers to provide strategic options for many bacterial infections. In 2015, AMR guidance for product development programmes, was recognized as a global public health challenge and to specify the intended use, target populations with the adoption of the Global Action Plan and desired attributes of potential new products. (GAP) by the sixty-eighth World Health Assembly, In the regulatory context, TPPs help to frame providing countries with a blueprint for action to development in relation to submission of product combat AMR both nationally and internationally.1 dossiers. In the context of public health, WHO TPPs set R&D targets for funders and developers by In response to GAP objective 5, WHO developed outlining the desired performance and operational the Global priority list of antibiotic-resistant characteristics of potential new products. bacteria and the report Antibacterial agents in 1 Global action plan on antimicrobial resistance. Geneva: World Health Organization; 2015 (https://www.who.int/antimicrobial-resistance/global- action-plan/en/, accessed 23 January 2020). 2 Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis. Geneva: World Health Organization; 2017 (WHO/EMP/IAU/2017.12; https://www.who.int/medicines/areas/rational_use/ prioritization-of-pathogens/en/, accessed 23 January 2020). 3 Antibacterial agents in clinical development: an analysis of the antibacterial clinical development pipeline, including tuberculosis. Geneva: World Health Organization; 2017 (WHO/EMP/IAU/2017.12; https://www.who.int/medicines/areas/rational_use/antibacterial_agents_clinical_ development/en/, accessed 23 January 2020). TARGET PRODUCT PROFILES FOR NEEDED ANTIBACTERIAL AGENTS 1 The TPP development process The TPPs for new antibacterial agents were developed the WHO standard procedure
Recommended publications
  • Ladenburg Thalmann Healthcare Conference

    Ladenburg Thalmann Healthcare Conference

    Ladenburg Thalmann Healthcare Conference July 13, 2021 Forward-looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, the design, initiation, timing and submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; expected broad access across payer channels for tebipenem HBr; the expected pricing of tebipenem HBr and the anticipated shift in treating patients from intravenous to oral administration; the initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and its research and development programs, including management’s assessment of such results; the direct and indirect impact of the pandemic caused by an outbreak of a new strain of coronavirus on the Company’s business and operations; the timing of the availability of data from the Company’s clinical trials; the timing of the Company’s filings with regulatory agencies; product candidate benefits; competitive position; business strategies; objectives of management; potential growth opportunities; potential market size; reimbursement matters; possible or assumed future results of operations; projected costs; and the Company’s cash forecast and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions.
  • Overcoming Fluoroquinolone Resistance: Mechanistic Basis of Non- Quinolone Antibacterials Targeting Type Ii Topoisomerases

    Overcoming Fluoroquinolone Resistance: Mechanistic Basis of Non- Quinolone Antibacterials Targeting Type Ii Topoisomerases

    OVERCOMING FLUOROQUINOLONE RESISTANCE: MECHANISTIC BASIS OF NON- QUINOLONE ANTIBACTERIALS TARGETING TYPE II TOPOISOMERASES By Elizabeth Grace Gibson Dissertation Submitted to the Faculty of the Graduate School of Vanderbilt University in partial fulfillment of the requirements for the degree of DOCTOR OF PHILOSOPHY in Pharmacology May 10, 2019 Nashville, Tennessee Approved: Neil Osheroff, Ph.D. Joey Barnett, Ph.D. Wendell S. Akers, Pharm.D., Ph.D. Sean Davies, Ph.D. Benjamin Spiller, Ph.D. Timothy R. Sterling, M.D. DEDICATION To all my family and church family who have supported and encouraged me over all my years in school. To Him who I put all my trust. Commit your way to the Lord, trust also in Him and He shall bring it to pass. Psalm 37:5 ii ACKNOWLEDGEMENTS I want to first thank my Ph.D. advisor, Dr. Neil Osheroff, for allowing me to work in his laboratory. Thank you for all your support and encouragement and just being an overall great mentor. You really know how to bring us up when we need it or give us an ego check when we get a little high and mighty when things are going well. I appreciate your supportiveness to careers outside academia. I also appreciate that you always have our best interest at heart. To Dr. Joe Deweese, my first research mentor and the one who instilled the love of topoisomerase research. Without your guidance I would not be where I am today. Thank you for introducing me to Neil and his laboratory and helping with the transition from research in your lab to his.
  • Spero Therapeutics to Present Data for All Pipeline Programs at Idweek 2020

    Spero Therapeutics to Present Data for All Pipeline Programs at Idweek 2020

    Spero Therapeutics to Present Data for All Pipeline Programs at IDWeek 2020 October 16, 2020 15 data presentations cover each of Spero’s three pipeline programs and include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial CAMBRIDGE, Mass., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that it will have 15 data presentations at the Infectious Disease Society of America (IDSA) IDWeek™ 2020 taking place virtually from October 21 - 25, 2020. Presentations will cover each of Spero’s three pipeline programs and include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial that evaluated Spero’s oral antibiotic investigational candidate, tebipenem HBr, for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line data from the trial demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP. Poster presentations include a poster on the Phase 1 clinical trial of SPR720, an oral antimicrobial investigational agent in clinical development by Spero for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. In December 2019, Spero announced
  • Company Presentation

    Company Presentation

    Company Presentation January 13, 2020 1 Forward-looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, the initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and its research and development programs, including management’s assessment of such results; regulatory activities, including the Company’s expectation that positive results from a single pivotal Phase 3 clinical trial of Tebipenem HBr and ancillary supportive studies to be conducted in parallel with the Phase 3 trial will support the approval of Tebipenem HBr; the timing of the availability of data from the Company’s clinical trials; the timing of the Company’s filings with regulatory agencies; product candidate benefits; competitive position; business strategies; objectives of management; potential growth opportunities; potential market size; reimbursement matters; possible or assumed future results of operations; projected costs; and the Company’s cash forecast and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. All statements other than statements
  • Tedizolid-Cyclodextrin System As Delayed-Release Drug Delivery with Antibacterial Activity

    Tedizolid-Cyclodextrin System As Delayed-Release Drug Delivery with Antibacterial Activity

    International Journal of Molecular Sciences Article Tedizolid-Cyclodextrin System as Delayed-Release Drug Delivery with Antibacterial Activity Magdalena Paczkowska-Walendowska 1 , Natalia Rosiak 1 , Ewa Tykarska 2 , Katarzyna Michalska 3, Anita Płazi ´nska 4, Wojciech Płazi ´nski 5, Daria Szymanowska 6 and Judyta Cielecka-Piontek 1,* 1 Department of Pharmacognosy, Faculty of Pharmacy, Poznan University of Medical Sciences, Swiecickiego 4, 61-781 Poznan, Poland; [email protected] (M.P.-W.); [email protected] (N.R.) 2 Department of Chemical Technology of Drugs, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznan, Poland; [email protected] 3 Department of Synthetic Drugs, National Medicines Institute, Chelmska 30/34, 00-725 Warsaw, Poland; [email protected] 4 Department of Biopharmacy, Faculty of Pharmacy, Medical University of Lublin, Chodzki 4a, 20-093 Lublin, Poland; [email protected] 5 Jerzy Haber Institute of Catalysis and Surface Chemistry Polish Academy of Sciences, Niezapominajek 8, 30-239 Krakow, Poland; [email protected] 6 Department of Biotechnology and Food Microbiology, Poznan University of Life Sciences, Wojska Polskiego 48, 60-627 Poznan, Poland; [email protected] * Correspondence: [email protected] Abstract: Progressive increase in bacterial resistance has caused an urgent need to introduce new antibiotics, one of them being oxazolidinones with their representative tedizolid. Despite the broad spectrum of activity of the parent tedizolid, it is characterized by low water solubility, which limits its use. The combination of the active molecule with a multifunctional excipient, which is cyclodextrins, Citation: Paczkowska- allows preservation of its pharmacological activity and modification of its physicochemical properties.
  • Consideration of Antibacterial Medicines As Part Of

    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.
  • Revision of Precautions

    Revision of Precautions

    Published by Translated by Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. Revision of Precautions Cefmenoxime hydrochloride (preparations for otic and nasal use), chloramphenicol (solution for topical use, oral dosage form), tetracycline hydrochloride (powders, capsules), polymixin B sulfate (powders), clindamycin hydrochloride, clindamycin phosphate (injections), benzylpenicillin potassium, benzylpenicillin benzathine hydrate, lincomycin hydrochloride hydrate, aztreonam, amoxicillin hydrate, ampicillin hydrate, ampicillin sodium, potassium clavulanate/amoxicillin hydrate, dibekacin sulfate (injections), sultamicillin tosilate hydrate, cefaclor, cefazolin sodium, cefazolin sodium hydrate, cephalexin (oral dosage form with indications for otitis media), cefalotin sodium, cefixime hydrate, cefepime dihydrochloride hydrate, cefozopran hydrochloride, cefotiam hydrochloride (intravenous injections), cefcapene pivoxil hydrochloride hydrate, cefditoren pivoxil, cefdinir, ceftazidime hydrate, cefteram pivoxil, ceftriaxone sodium hydrate, cefpodoxime proxetil, cefroxadine hydrate, cefuroxime axetil, tebipenem pivoxil, doripenem hydrate, bacampicillin hydrochloride, panipenem/betamipron, faropenem sodium hydrate, flomoxef sodium, fosfomycin calcium hydrate, meropenem hydrate, chloramphenicol sodium succinate,
  • Title Layout

    Title Layout

    Antibiotics – an update on recently approved and investigational drugs Jenner Minto, Pharm.D. Disclosures • Nothing to disclose Learning Objectives • Describe the use of new antibacterial agents in clinical practice • Describe the therapeutic potential of antibiotics currently in development Assessment Questions 1. Which of the following statements regarding new antibacterial agents is true? A. Most are FDA approved to treat a broad range of infections B. Recently approved antibiotics are likely to become first-line agents C. Many have a novel mechanism of action D. Most are reserved for infections caused by organisms that are resistant to existing antibiotics 2. The majority of antibiotics currently in development target which pathogen(s)? A. Gram-positive organisms B. Gram-negative ESKAPE pathogens C. Drug-resistant Neisseria gonorrheae D. Drug-resistant Clostridioides difficile Recently Approved Antibiotics 2018 Approvals Plazomicin (Zemdri®) Evracycline (Xerava®) Sarecycline (Seysara®) Omadacycline (Nuzyra®) Rifamycin (Aemcolo®) 2019 Approvals Imipenem, cliastatin, relebactam (Recabrio®) Pretomanid Lefamulin (Xenleta®) Cefiderocol (Fetroja®) Plazomicin (Zemdri®) Approved • June, 2019 Indications • Complicated urinary tract infections (cUTIs), including pyelonephritis, caused by: E. coli, K. pneumoniae, P. mirabilis, Enterobacter cloacae *Reserved for patients ≥ 18 years of age with limited or no alternative treatment options https://zemdri.com/ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf
  • Oral Antibiotics in Clinical Development for Community-Acquired Urinary Tract Infections

    Oral Antibiotics in Clinical Development for Community-Acquired Urinary Tract Infections

    Infect Dis Ther https://doi.org/10.1007/s40121-021-00509-4 COMMENTARY Oral Antibiotics in Clinical Development for Community-Acquired Urinary Tract Infections Balaji Veeraraghavan . Yamuna Devi Bakthavatchalam . Rani Diana Sahni Received: May 16, 2021 / Accepted: July 21, 2021 Ó The Author(s) 2021 ABSTRACT UTI. The b-lactamase inhibitors ETX0282, VNRX7145, ARX1796, and QPX7728 are com- The treatment of urinary tract infections (UTIs) bined with cefpodoxime proxetil or ceftibuten has been complicated by the emergence of that achieve favorable exposures in urine com- multidrug-resistant, b-lactamase-expressing pared to other uropathogen-active oral cepha- pathogens. As a result of the limited treatment losporins. The combination ceftibuten- options, patients often require hospitalization QPX7728 has potential broad-spectrum cover- and intravenous therapy. In essence, a strong age against carbapenemase producers including unmet need for oral antibiotics, active against metallo b-lactamase producers. Other novel extended-spectrum b-lactamase (ESBL) uro- combinations, namely cefpodoxime/ETX0282, pathogens has emerged. Oral carbapenems (te- ceftibuten/VNRX-7145, and ceftibuten/ bipenem and sulopenem) and oral ARX1796, have also demonstrated excellent cephalosporin/b-lactamase inhibitor combina- activity against Klebsiella pneumoniae carba- tions are in various stages of clinical develop- panemase (KPC) and OXA-48-like producers. All ment for the treatment of uncomplicated and these agents, upon their arrival for commercial complicated UTI. Tebipenem, if approved, will use, would strengthen the outpatient therapy. be the first oral treatment for complicated UTI while sulopenem will be for uncomplicated Keywords: Ceftibuten; Cefpodoxime; Tebipenem; Sulopenem; ETX0282; VNRX7145; ARX1796; QPX7728 B. Veeraraghavan (&) Á Y. D. Bakthavatchalam Á R. D.
  • ESAC-Net Reporting Protocol 2019.Docx

    ESAC-Net Reporting Protocol 2019.Docx

    TESSy - The European Surveillance System Antimicrobial consumption (AMC) reporting protocol 2019 European Surveillance of Antimicrobial Consumption Network (ESAC-Net) surveillance data for 2018 March 2019 Contents Introduction ............................................................................................................... 4 ESAC-Net ........................................................................................................................... 4 AMC metadata changes 2019 ............................................................................................... 5 Summary of the TESSy AMC data upload and validation process ........................................... 5 Annual ESAC-Net data collection .......................................................................................... 6 Overview of AMC data collection and analysis ....................................................................... 6 How to use this document .................................................................................................... 8 Finding further information .................................................................................................... 8 Reporting to TESSy ................................................................................................... 9 Data collection schedule ....................................................................................................... 9 Preparing data ....................................................................................................................
  • Nippon AMR One Health Report (NAOR) 2019

    Nippon AMR One Health Report (NAOR) 2019

    Nippon AMR One Health Report (NAOR) 2019 November 27, 2019 The AMR One Health Surveillance Committee TABLE OF CONTENTS Preface .................................................................................................................................................................... 1 Abbreviations ......................................................................................................................................................... 2 Types and Abbreviations of Antimicrobials ........................................................................................................... 3 Executive Summary ................................................................................................................................................ 6 Outcome Indices for the Action Plan...................................................................................................................... 9 Current Status of Antimicrobial-resistant Bacteria in Japan ................................................................................. 10 (1) Humans ......................................................................................................................................................................... 11 1) Gram-negative bacteria ................................................................................................................................................. 11 2) Gram-positive bacteria .................................................................................................................................................
  • Antibacterial Prodrugs to Overcome Bacterial Resistance

    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.