DOCSLIB.ORG

Antibiotics Currently in Clinical Development

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Antibiotics Currently in Clinical Development A data table from Feb 2014 Antibiotics Currently in Clinical Development As of February 2014, there are at least 45 new antibiotics1 with the potential to treat serious bacterial infections in clinical development for the U.S. market. The success rate for drug development is low; at best, only 1 in 5 candidates that enter human testing will be approved for patients.* This snapshot of the antibiotic pipeline will be updated periodically as products advance or are known to drop out of development. Please contact Rachel Zetts at [email protected] or 202-540-6557 with additions or updates. Cited for Potential Development Known QIDP4 Drug Name Company Drug Class Activity Against Gram- Potential Indication(s)5 Phase2 Designation? Negative Pathogens?3 New Drug Application Acute bacterial skin and skin structure Oritavancin The Medicines Company Glycopeptide Yes (NDA) submitted infections New Drug Application Acute bacterial skin and skin structure Dalbavancin Durata Therapeutics Lipoglycopeptide Yes (NDA) submitted infections NDA submitted (for Acute bacterial skin and skin structure acute bacterial skin infections, hospital acquired bacterial Tedizolid Cubist Pharmaceuticals Oxazolidinone Yes and skin structure pneumonia/ventilator acquired bacterial infection indication) pneumonia ACHN-975 Phase 1 Achaogen LpxC inhibitor Yes Bacterial infections Acute bacterial skin and skin structure infections6, methicillin-resistant Fabl inhibitor (AFN-1252 AFN-1720 Phase 1 Affinium Pharmaceuticals Staphylococcus aureus (MRSA) pulmonary pro-drug) infections in cystic fibrosis patients6, osteomyelitis6, bone and joint infections6 AZD0914 Phase 1 AstraZeneca DNA gyrase inhibitor Yes Gonococcal infections Aztreonam+Avibactam7 AstraZeneca/Forest Monobactam + novel beta- Phase 1 Yes Bacterial infections (ATM-AVI) Laboratories lactamase inhibitor Multidrug-resistant Gram-negative bacterial BAL30072 Phase 1 Basilea Pharmaceutica Monosulfactam Yes infections6 Complicated urinary tract infections, Rempex Carbapenem (biapenem) complicated intra-abdominal infections, Carbavance Phase 1 Pharmaceuticals/the + novel boronic beta- Yes Yes hospital-acquired bacterial pneumonia/ Medicines Co. lactamase inhibitor ventilator-associated bacterial pneumonia, febrile neutropenia. Cited for Potential Development Known QIDP4 Drug Name Company Drug Class Activity Against Gram- Potential Indication(s)5 Phase2 Designation? Negative Pathogens?3 Methionyl tRNA synthetase CRS-3123 Phase 1 Crestone, Inc. C. difficile infection6 (MetRS) inhibitor EDP-788 Phase 1 Enanta Pharmaceuticals Bicyclolide Bacterial infections GlaxoSmithKline GSK-2696266 Phase 1 Cephalosporin Bacterial infections6 (partnered product) LegoChem Biosciences LCB01-0371 Phase 1 Oxazolidinone Bacterial infections (S. Korea) Bacterial infections including community- MRX-I Phase 1 MicuRx Pharmaceuticals Oxazolidinone acquired MRSA and vancomycin-resistant enterococci infections6 Macrocycle (peptide Polyphor (Roche POL7080 Phase 1 epitope mimetic) LptD Yes (Pseudomonas) Bacterial infections caused by Pseudomonas6 licensee) inhibitor Serious Gram-positive bacterial infections (acute bacterial skin and skin structure Glycopeptide- TD-1607 Phase 1 Theravance, Inc. infections, hospital-acquired pneumonia/ cephalosporin heterodimer ventilator-associated pneumonia, bacteremia)6 Fluoroquinolone (WCK 771 WCK 2349 Phase 1 Wockhardt Bacterial infections pro-drug) WCK 771 Phase 1 Wockhardt Fluoroquinolone Bacterial infections Acute bacterial skin and skin structure AFN-1252 Phase 2 Affinium Pharmaceuticals Fabl inhibitor Yes infections Community-acquired bacterial pneumonia, Avarofloxacin Phase 2 Furiex Pharmaceuticals Fluoroquinolone Yes Yes acute bacterial skin and skin structure infections Acute bacterial skin and skin structure Brilacidin Phase 2 Cellceutix Corp. Defensin-mimetic infections6 AstraZeneca/Forest Cephalosporin + novel Ceftaroline+Avibactam8 Phase 2 Yes Complicated urinary tract infections Laboratories beta-lactamase inhibitor Acute bacterial skin and skin structure CG-400549 Phase 2 CrystalGenomics, Inc. Fabl inhibitor infections; osteomyelitis6 Complicated urinary tract infections, acute pyelonephritis (kidney infection), acute Finafloxacin Phase 2 MerLion Pharmaceuticals Fluoroquinolone Yes Yes intra-abdominal infections, acute bacterial skin and skin structure infections Peptide deformylase Acute bacterial skin and skin structure GSK-1322322 Phase 2 GlaxoSmithKline inhibitor infections Cited for Potential Development Known QIDP4 Drug Name Company Drug Class Activity Against Gram- Potential Indication(s)5 Phase2 Designation? Negative Pathogens?3 Type 2 topoisomerase Respiratory tract infections, acute bacterial GSK-2140944 Phase 2 GlaxoSmithKline inhibitor skin and skin structure infections Acute bacterial skin and skin structure Lefamulin (BC-3781) Phase 2 Nabriva Therapeutics Pleuromutilin infections LFF571 Phase 2 Novartis Elongation factor inhibitor Clostridium difficile-associated diarrhea Complicated urinary tract infections, acute MK-7655+ Carbapenem + novel beta- Phase 2 Merck & Co. Yes pyelonephritis, complicated intra-abdominal (imipenem/cilastatin)8 lactamase inhibitor infections Community-acquired bacterial pneumonia, Nemonoxacin9 Phase 2 TaiGen Biotechnology Quinolone Yes Yes diabetic foot infection, acute bacterial skin and skin structure infections Community-acquired bacterial pneumonia, acute bacterial skin and skin structure Omadacycline Phase 2 Paratek Pharmaceuticals Tetracycline Yes Yes infections, complicated urinary tract infections Acute bacterial skin and skin structure Radezolid Phase 2 Melinta Pharmaceuticals Oxazolidinone Yes Yes infections, community-acquired bacterial pneumonia Ramoplanin Phase 2 Nanotherapeutics Lipoglycopeptide Clostridium difficile-associated diarrhea6 Taksta (Fusidic acid)10 Phase 2 Cempra Pharmaceuticals Fusidane Prosthetic joint infections Acute bacterial skin and skin structure infections, other serious infections caused by Glycopeptide- TD-1792 Phase 2 Theravance, Inc. Gram-positive bacteria including hospital- cephalosporin heterodimer acquired pneumonia/ventilator-associated pneumonia and bacteremia6 Dong Wha Zabofloxacin Phase 2 Fluoroquinolone Community-acquired bacterial pneumonia Pharmaceutical Cadazolid Phase 3 Actelion Pharmaceuticals Quinolonyl-oxazolidinone Yes Clostridium difficile-associated diarrhea Complicated urinary tract infections, complicated intra-abdominal infections, Ceftazidime+Avibactam AstraZeneca/Forest Cephalosporin + novel Phase 3 Yes Yes acute pyelonephritis (kidney infection), (CAZ-AVI)8 Laboratories beta-lactamase inhibitor hospital-acquired bacterial pneumonia/ ventilator-associated bacterial pneumonia Complicated urinary tract infections, complicated intra-abdominal infections, Novel cephalosporin+beta- Ceftolozane+Tazobactam8 Phase 3 Cubist Pharmaceuticals Yes Yes acute pyelonephritis (kidney infection), lactamase inhibitor hospital-acquired bacterial pneumonia/ ventilator-associated pneumonia Cited for Potential Development Known QIDP4 Drug Name Company Drug Class Activity Against Gram- Potential Indication(s)5 Phase2 Designation? Negative Pathogens?3 Acute bacterial skin and skin structure Delafloxacin Phase 3 Melinta Pharmaceuticals Fluoroquinolone Yes Yes infections, community-acquired bacterial pneumonia, uncomplicated gonorrhea Complicated intra-abdominal infections, Tetraphase Eravacycline8 Phase 3 Tetracycline Yes Yes complicated urinary tract infections, Pharmaceuticals hospital-acquired bacterial pneumonia6 Bloodstream infections and nosocomial Plazomicin8 Phase 3 Achaogen Aminoglycoside Yes pneumonia caused by carbapenem-resistant Enterobacteriaeceae Community-acquired bacterial pneumonia, Solithromycin Phase 3 Cempra Pharmaceuticals Macrolide (ketolide) Yes Yes uncomplicated urogenital gonorrhea Surotomycin Phase 3 Cubist Pharmaceuticals Lipopeptide Yes Clostridium difficile-associated diarrhea Hospital-acquired bacterial pneumonia, Ceftobiprole Phase 311 Basilea Pharmaceutica Cephalosporin Yes community-acquired bacterial pneumonia * M. Hay et al. “Clinical Development Success Rates for Investigational Drugs,” Nature Biotechnology 32, no. 1 (2014): 40-51. - See more at: http://www.pewhealth.org/other-resource/antibiotics-currently-in-clinical- development-85899541594#sthash.XLzMLQta.dpuf References 1. Antibiotics include products containing at least one component not approved in the United 4. Certain antibiotics intended to treat serious or life-threatening infections can be designated by States previously. All analyses were strictly limited to systemic antibiotics (drugs that work the Food and Drug Administration as qualified infectious disease products, or QIDPs. QIDPs are throughout the body) and drugs to treat Clostridium difficile-associated disease. The Centers eligible to receive benefits under the Generating Antibiotic Incentives Now Act (signed into law for Disease Control and Prevention cited Clostridium difficile as an urgent public health threat as part of the Food and Drug Administration Safety and Innovation Act), including expedited FDA in a 2013 report (Antibiotic Resistance Threats in the United States, 2013, Sept. 16, 2013, http:// review and extended exclusivity for approved products. www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf). We excluded 5. Based on clinical trials currently registered in clinicaltrials.gov and/or reported QIDP designations biological products, vaccines, and locally acting drugs such as topical, ophthalmic, and inhaled unless
Load more

Recommended publications
  • WO 2015/179249 Al 26 November 2015 (26.11.2015) P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2015/179249 Al 26 November 2015 (26.11.2015) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C12N 15/11 (2006.01) A61K 38/08 (2006.01) kind of national protection available): AE, AG, AL, AM, C12N 15/00 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (21) Number: International Application DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US2015/031213 HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (22) International Filing Date: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, 15 May 2015 (15.05.2015) MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (25) Filing Language: English SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (26) Publication Language: English TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 62/000,43 1 19 May 2014 (19.05.2014) US kind of regional protection available): ARIPO (BW, GH, 62/129,746 6 March 2015 (06.03.2015) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, (72) Inventors; and TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicants : GELLER, Bruce, L.
    [Show full text]
  • Brilacidin First-In-Class Defensin-Mimetic Drug Candidate
    Brilacidin First-in-Class Defensin-Mimetic Drug Candidate Mechanism of Action, Pre/Clinical Data and Academic Literature Supporting the Development of Brilacidin as a Potential Novel Coronavirus (COVID-19) Treatment April 20, 2020 Page # I. Brilacidin: Background Information 2 II. Brilacidin: Two Primary Mechanisms of Action 3 Membrane Disruption 4 Immunomodulatory 7 III. Brilacidin: Several Complementary Ways of Targeting COVID-19 10 Antiviral (anti-SARS-CoV-2 activity) 11 Immuno/Anti-Inflammatory 13 Antimicrobial 16 IV. Brilacidin: COVID-19 Clinical Development Pathways 18 Drug 18 Vaccine 20 Next Steps 24 V. Brilacidin: Phase 2 Clinical Trial Data in Other Indications 25 VI. AMPs/Defensins (Mimetics): Antiviral Properties 30 VII. AMPs/Defensins (Mimetics): Anti-Coronavirus Potential 33 VIII. The Broader Context: Characteristics of the COVID-19 Pandemic 36 Innovation Pharmaceuticals 301 Edgewater Place, Ste 100 Wakefield, MA 01880 978.921.4125 [email protected] Innovation Pharmaceuticals: Mechanism of Action, Pre/Clinical Data and Academic Literature Supporting the Development of Brilacidin as a Potential Novel Coronavirus (COVID-19) Treatment (April 20, 2020) Page 1 of 45 I. Brilacidin: Background Information Brilacidin (PMX-30063) is Innovation Pharmaceutical’s lead Host Defense Protein (HDP)/Defensin-Mimetic drug candidate targeting SARS-CoV-2, the virus responsible for COVID-19. Laboratory testing conducted at a U.S.-based Regional Biocontainment Laboratory (RBL) supports Brilacidin’s antiviral activity in directly inhibiting SARS-CoV-2 in cell-based assays. Additional pre-clinical and clinical data support Brilacidin’s therapeutic potential to inhibit the production of IL-6, IL-1, TNF- and other pro-inflammatory cytokines and chemokines (e.g., MCP-1), identified as central drivers in the worsening prognoses of COVID-19 patients.
    [Show full text]
  • United States Patent ( 10 ) Patent No.: US 10,561,6759 B2 Griffith Et Al
    US010561675B2 United States Patent ( 10 ) Patent No.: US 10,561,6759 B2 Griffith et al. (45 ) Date of Patent : * Feb . 18 , 2020 (54 ) CYCLIC BORONIC ACID ESTER ( 58 ) Field of Classification Search DERIVATIVES AND THERAPEUTIC USES CPC A61K 31/69 ; A61K 31/396 ; A61K 31/40 ; THEREOF A61K 31/419677 (71 ) Applicant: Rempex Pharmaceuticals , Inc. , (Continued ) Lincolnshire , IL (US ) (56 ) References Cited (72 ) Inventors : David C. Griffith , San Marcos, CA (US ) ; Michael N. Dudley , San Diego , U.S. PATENT DOCUMENTS CA (US ) ; Olga Rodny , Mill Valley , CA 4,194,047 A 3/1980 Christensen et al . ( US ) 4,260,543 A 4/1981 Miller ( 73 ) Assignee : REMPEX PHARMACEUTICALS , ( Continued ) INC . , Lincolnshire , IL (US ) FOREIGN PATENT DOCUMENTS ( * ) Notice : Subject to any disclaimer, the term of this EP 1550657 A1 7/2005 patent is extended or adjusted under 35 JP 2003-229277 A 8/2003 U.S.C. 154 ( b ) by 1129 days. (Continued ) This patent is subject to a terminal dis claimer . OTHER PUBLICATIONS Abdel -Magid et al. , “ Reductive Amination ofAldehydes and Ketones ( 21) Appl. No .: 13 /843,579 with Sodium Triacetoxyborohydride: Studies on Direct and Indirect Reductive Amination Procedures ” , J Org Chem . ( 1996 )61 ( 11 ): 3849 ( 22 ) Filed : Mar. 15 , 2013 3862 . (65 ) Prior Publication Data (Continued ) US 2013/0331355 A1 Dec. 12 , 2013 Primary Examiner — Shengjun Wang Related U.S. Application Data (74 ) Attorney, Agent, or Firm — Wilmer Cutler Pickering (60 ) Provisional application No.61 / 656,452 , filed on Jun . Hale and Dorr LLP 6 , 2012 (57 ) ABSTRACT (51 ) Int. Ci. A61K 31/69 ( 2006.01) Method of treating or ameliorating a bacterial infection A61K 31/00 ( 2006.01 ) comprising administering a composition comprising a cyclic (Continued ) boronic acid ester compound in combination with a car ( 52 ) U.S.
    [Show full text]
  • AMR Surveillance in Pharma: a Case-Study for Data Sharingauthor by Professor Barry Cookson
    AMR Open Data Initiative AMR Surveillance in Pharma: a case-study for data sharingauthor by Professor Barry Cookson External Consultant to Project eLibrary • Division of Infection and Immunity, Univ. College London ESCMID• Dept. of Microbiology, © St Thomas’ Hospital Background of “90 day Project” Addressed some recommendations of the first Wellcome funded multi-disciplinary workshop (included Pharma Academia & Public Health invitees: 27thauthor July 2017 (post the Davos Declaration): by 1) Review the landscape of existing Pharma AMR programmes, their protocols,eLibrary data standards and sets 2) Develop a "portal" (register/platform) to access currently available AMR Surveillance data ESCMID Important ©to emphasise that this is a COLLABORATION between Pharma and others Overview of Questionnaire Content • General information - including name,author years active, countries, antimicrobials, microorganisms.by • Methodology - including accreditation, methodology for; surveillance, isolate collection, organism identification, breakpointseLibrary used, • Dataset - including data storage methodology, management and how accessed. ESCMID © 13 Company Responses author 7 by 3 3 eLibrary ESCMID © Structure of register Companies can have different ways of referring to their activities: We had to choose a consistent framework. author Companies Companyby 1 Programmes Programme A Programme B eLibrary Antimicrobials 1 2 3 4 5 company’s product comparator company’s product antimicrobials Programmes canESCMID contain multiple studies (e.g. Pfizer has© single
    [Show full text]
  • Criteria for Use of Dalbavancin for Acute Bacterial Skin/Soft Tissue Infection (Abssti)
    Criteria for Use of Dalbavancin for Acute Bacterial Skin/Soft Tissue Infection (abSSTI) 1. Patients meeting any of the following are NOT ELIGIBLE for dalbavancin therapy: a. History of hypersensitivity reaction to lipoglycopeptide antibiotics (vancomycin, televancin, dalbavancin, oritavancin). b. Patients with acute bacterial skin or skin structure infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. c. Infection thought to be caused by gram-negative bacteria d. Infection due to an organism suspected or known to be resistant to dalbavancin or vancomycin 2. For outpatient use (i.e. ED) a. Contact infectious disease for authorization: ABX approval pager (see ON-CALL schedule) b. The following clinical criteria must be met: i. Pre-antibiotic blood cultures must be drawn. ii. Clinical condition expected to require ≥ 24 hours of IV antibiotics – must not qualify for oral antibiotic therapy. iii. Presence of cellulitis, major abscess or a wound infection associated with at least 75cm2 of erythema highly suspected or known to be caused by gram-positive bacteria. iv. The size of the infection must be clearly documented and/or outlined prior to leaving the ED, preferably with a photograph. v. Patient to be discharged to home ± home health (not to skilled nursing facility). c. Required follow up must be set up prior to leaving the ED: i. Must document patient contact info for follow up, preferably reliable cell phone number. ii. Must have follow up within 48-72H with Dr. Turnipseed (916-765-0196) or Rominski. 1. Email patient name, MRN, and phone number.
    [Show full text]
  • Current Topics in Medicinal Chemistry, 2017, 17, 576-589
    576 Send Orders for Reprints to [email protected] Current Topics in Medicinal Chemistry, 2017, 17, 576-589 REVIEW ARTICLE ISSN: 1568-0266 eISSN: 1873-5294 Impact Factor: Mimics of Host Defense Proteins; Strategies for Translation to Therapeutic 2.9 The international journal for in-depth reviews on Applications Current Topics in Medicinal Chemistry BENTHAM SCIENCE Richard W. Scott*,1 and Gregory N. Tew2 1Fox Chase Chemical Diversity Center, Pennsylvania Biotechnology Center, Doylestown, PA, USA; 2Polymer Science and Engineering, Veterinary and Animal Science, Cell and Molecular Biology, University of Massachusetts, Amherst MA, USA Abstract: New infection treatments are urgently needed to combat the rising threat of multi-drug re- sistant bacteria. Despite early clinical set-backs attention has re-focused on host defense proteins (HDPs), as potential sources for new and effective antimicrobial treatments. HDPs appear to act at multiple targets and their repertoire includes disruptive membrane and intracellular activities against numerous types of pathogens as well as immune modulatory functions in the host. Importantly, these novel activities are associated with a low potential for emergence of resistance and little cross- resistance with other antimicrobial agents. Based on these properties, HDPs appear to be ideal candi- A R T I C L E H I S T O R Y dates for new antibiotics; however, their development has been plagued by the many therapeutic limi- tations associated with natural peptidic agents. This review focuses on HDP mimetic approaches Received: May 22, 2015 Revised: October 29, 2015 aimed to improve metabolic stability, pharmacokinetics, safety and manufacturing processes. Early ef- Accepted: November 30, 2015 forts with β-peptide or peptoid analogs focused on recreating stable facially amphiphilic structures but DOI: 10.2174/15680266166661607 demonstrated that antimicrobial activity was modulated by more, complex structural properties.
    [Show full text]
  • B-Lactams: Chemical Structure, Mode of Action and Mechanisms of Resistance
    b-Lactams: chemical structure, mode of action and mechanisms of resistance Ru´ben Fernandes, Paula Amador and Cristina Prudeˆncio This synopsis summarizes the key chemical and bacteriological characteristics of b-lactams, penicillins, cephalosporins, carbanpenems, monobactams and others. Particular notice is given to first-generation to fifth-generation cephalosporins. This review also summarizes the main resistance mechanism to antibiotics, focusing particular attention to those conferring resistance to broad-spectrum cephalosporins by means of production of emerging cephalosporinases (extended-spectrum b-lactamases and AmpC b-lactamases), target alteration (penicillin-binding proteins from methicillin-resistant Staphylococcus aureus) and membrane transporters that pump b-lactams out of the bacterial cell. Keywords: b-lactams, chemical structure, mechanisms of resistance, mode of action Historical perspective Alexander Fleming first noticed the antibacterial nature of penicillin in 1928. When working with Antimicrobials must be understood as any kind of agent another bacteriological problem, Fleming observed with inhibitory or killing properties to a microorganism. a contaminated culture of Staphylococcus aureus with Antibiotic is a more restrictive term, which implies the the mold Penicillium notatum. Fleming remarkably saw natural source of the antimicrobial agent. Similarly, under- the potential of this unfortunate event. He dis- lying the term chemotherapeutic is the artificial origin of continued the work that he was dealing with and was an antimicrobial agent by chemical synthesis [1]. Initially, able to describe the compound around the mold antibiotics were considered as small molecular weight and isolates it. He named it penicillin and published organic molecules or metabolites used in response of his findings along with some applications of penicillin some microorganisms against others that inhabit the same [4].
    [Show full text]
  • Penicillin Allergy Guidance Document
    Penicillin Allergy Guidance Document Key Points Background Careful evaluation of antibiotic allergy and prior tolerance history is essential to providing optimal treatment The true incidence of penicillin hypersensitivity amongst patients in the United States is less than 1% Alterations in antibiotic prescribing due to reported penicillin allergy has been shown to result in higher costs, increased risk of antibiotic resistance, and worse patient outcomes Cross-reactivity between truly penicillin allergic patients and later generation cephalosporins and/or carbapenems is rare Evaluation of Penicillin Allergy Obtain a detailed history of allergic reaction Classify the type and severity of the reaction paying particular attention to any IgE-mediated reactions (e.g., anaphylaxis, hives, angioedema, etc.) (Table 1) Evaluate prior tolerance of beta-lactam antibiotics utilizing patient interview or the electronic medical record Recommendations for Challenging Penicillin Allergic Patients See Figure 1 Follow-Up Document tolerance or intolerance in the patient’s allergy history Consider referring to allergy clinic for skin testing Created July 2017 by Macey Wolfe, PharmD; John Schoen, PharmD, BCPS; Scott Bergman, PharmD, BCPS; Sara May, MD; and Trevor Van Schooneveld, MD, FACP Disclaimer: This resource is intended for non-commercial educational and quality improvement purposes. Outside entities may utilize for these purposes, but must acknowledge the source. The guidance is intended to assist practitioners in managing a clinical situation but is not mandatory. The interprofessional group of authors have made considerable efforts to ensure the information upon which they are based is accurate and up to date. Any treatments have some inherent risk. Recommendations are meant to improve quality of patient care yet should not replace clinical judgment.
    [Show full text]
  • 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.
    [Show full text]
  • Cyslabdan, a New Potentiator of Imipenem Activity Against Methicillin-Resistant Staphylococcus Aureus, Produced by Streptomyces Sp
    J. Antibiot. 61(1): 7–10, 2008 THE JOURNAL OF ORIGINAL ARTICLE ANTIBIOTICS Cyslabdan, a New Potentiator of Imipenem Activity against Methicillin-resistant Staphylococcus aureus, Produced by Streptomyces sp. K04-0144 II. Biological Activities Atsushi Fukumoto, Yong-Pil Kim, Hideaki Hanaki, Kazuro Shiomi, Hiroshi Tomoda, Satoshi O¯ mura Received: October 5, 2007 / Accepted: December 4, 2007 © Japan Antibiotics Research Association Abstract Cyslabdan produced by Streptomyces sp. K04- 0144 was found to potentiate imipenem activity against methicillin-resistant Staphylococcus aureus (MRSA). The MIC value of imipenem against MRSA was reduced from 16 to 0.015 mg/ml in combination with cyslabdan. Study on anti-MRSA activity of other typical antibiotics in combination with cyslabdan showed that the potentiating activity was limited to b-lactam antibiotics. Furthermore, among b-lactam antibiotics, the activity of carbapenems Fig. 1 Structure of cyslabdan. was most remarkably poteintiated by cyslabdan. Keywords cyslabdan, imipenem potentiator, cyslabdan including potentiation of imipenem activity methicillin-resistant Staphylococcus aureus, MRSA, against MRSA are described. Streptomyces sp. K04-0144, b-lactam Materials and Methods Introduction Materials During our screening for potentiators of imipenem activity The following materials were purchased from commercial against methicillin-resistant Staphylococcus aureus sources: Cloxacillin (ICN Biomedicals), ampicillin (Wako), (MRSA) from microbial metabolites, cyslabdan (Fig. 1) cefalexin (Wako), cefazolin (Wako), ciprofloxacin (Wako), was isolated from the culture broth of Streptomyces sp. vancomycin (Wako), tetracycline (Wako), biapenem (Meiji K04-0144. The compound has a labdane-type diterpene Seika), streptomycin (Meiji Seika), meropenem (Sumitomo skeleton connecting with an N-acetylcysteine via thioether Pharmaceuticals), panipenem (Sankyo), penicillin G linkage [1]. In this study, the biological activities of (Sigma), cefotaxime (Sigma), cefmetazole (Sigma), and S.
    [Show full text]
  • WO 2010/025328 Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 4 March 2010 (04.03.2010) WO 2010/025328 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (21) International Application Number: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, PCT/US2009/055306 DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 28 August 2009 (28.08.2009) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (26) Publication Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/092,497 28 August 2008 (28.08.2008) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): FOR¬ GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, EST LABORATORIES HOLDINGS LIMITED [IE/ ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, —]; 18 Parliament Street, Milner House, Hamilton, TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, Bermuda HM12 (BM).
    [Show full text]
  • Computational Antibiotics Book
    Andrew V DeLong, Jared C Harris, Brittany S Larcart, Chandler B Massey, Chelsie D Northcutt, Somuayiro N Nwokike, Oscar A Otieno, Harsh M Patel, Mehulkumar P Patel, Pratik Pravin Patel, Eugene I Rowell, Brandon M Rush, Marc-Edwin G Saint-Louis, Amy M Vardeman, Felicia N Woods, Giso Abadi, Thomas J. Manning Computational Antibiotics Valdosta State University is located in South Georgia. Computational Antibiotics Index • Computational Details and Website Access (p. 8) • Acknowledgements (p. 9) • Dedications (p. 11) • Antibiotic Historical Introduction (p. 13) Introduction to Antibiotic groups • Penicillin’s (p. 21) • Carbapenems (p. 22) • Oxazolidines (p. 23) • Rifamycin (p. 24) • Lincosamides (p. 25) • Quinolones (p. 26) • Polypeptides antibiotics (p. 27) • Glycopeptide Antibiotics (p. 28) • Sulfonamides (p. 29) • Lipoglycopeptides (p. 30) • First Generation Cephalosporins (p. 31) • Cephalosporin Third Generation (p. 32) • Fourth-Generation Cephalosporins (p. 33) • Fifth Generation Cephalosporin’s (p. 34) • Tetracycline antibiotics (p. 35) Computational Antibiotics Antibiotics Covered (in alphabetical order) Amikacin (p. 36) Cefempidone (p. 98) Ceftizoxime (p. 159) Amoxicillin (p. 38) Cefepime (p. 100) Ceftobiprole (p. 161) Ampicillin (p. 40) Cefetamet (p. 102) Ceftoxide (p. 163) Arsphenamine (p. 42) Cefetrizole (p. 104) Ceftriaxone (p. 165) Azithromycin (p.44) Cefivitril (p. 106) Cefuracetime (p. 167) Aziocillin (p. 46) Cefixime (p. 108) Cefuroxime (p. 169) Aztreonam (p.48) Cefmatilen ( p. 110) Cefuzonam (p. 171) Bacampicillin (p. 50) Cefmetazole (p. 112) Cefalexin (p. 173) Bacitracin (p. 52) Cefodizime (p. 114) Chloramphenicol (p.175) Balofloxacin (p. 54) Cefonicid (p. 116) Cilastatin (p. 177) Carbenicillin (p. 56) Cefoperazone (p. 118) Ciprofloxacin (p. 179) Cefacetrile (p. 58) Cefoselis (p. 120) Clarithromycin (p. 181) Cefaclor (p.
    [Show full text]