Comparative Activity of Newer Antibiotics Against Gram-Negative Bacilli
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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
28912 Oxoid FDA Cartridge Tables:1
* Adapted in part from CLSI document M100-S23 (M02-A11) : “Disc diffusion supplemental tablesʼʼ Performance standards for antimicrobial susceptibility testing. The complete standard may be obtained from the Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19807. Test Cultures (zone diameters in mm) Antimicrobial Agent Disc Code Potency Resistant Intermediate Susceptible Amikacin AK 30 μg EnterobacteriaceaeK, P. aeruginosa, Acinetobacter spp., and Staphylococcus spp. ≤14 15-16 ≥17 Amoxycillin - Clavulanic Acid AMC 20/10 μg EnterobacteriaceaeE ≤13 14-17 ≥18 Staphylococcus spp.A,Q ≤19 — ≥20 Haemophilus spp.A,Y ≤19 — ≥20 AmpicillinC,n AMP 10 μg EnterobacteriaceaeE and Vibrio choleraef ≤13 14-16 ≥17 Staphylococcus spp.A,Q ≤28 — ≥29 Enterococcus spp.A,V,W,k,m ≤16 — ≥17 Haemophilus spp.Y ≤18 19-21 ≥22 Streptococcus spp. ß-Hemolytic GroupA,d — — ≥24 Ampicillin – Sulbactam SAM 10/10 μg EnterobacteriaceaeE, Acinetobacter spp., and Staphylococcus spp. ≤11 12-14 ≥15 Haemophilus spp.A,Y ≤19 — ≥20 Azithromycin AZM 15 μg Staphylococcus spp., Streptococcus spp Viridans Groupn, ß-Hemolytic Group, and S. pneumoniae) ≤13 14-17 ≥18 Neisseria meningitidisA,i — — ≥20 Haemophilus spp.A — — ≥12 Aztreonam ATM 30 μg EnterobacteriaceaeE ≤17 18-20 ≤21 P. aeruginosa ≤15 16-21 ≥22 Haemophilus spp.A — — ≥26 CAR 100 μg Carbenicillin Enterobacteriaceae ≤19 20-22 ≥23 Pseudomonas aeruginosaP ≤13 14-16 ≥17 CEC 30 μg Cefaclor Enterobacteriaceae and Staphylococcus spp. ≤14 15-17 ≥18 Haemophilus spp.Y ≤16 17-19 ≥20 MA 30 μg Cefamandole EnterobacteriaceaeD,E and Staphylococcus spp. ≤14 15-17 ≥18 CefazolinG KZ 30 μg Staphylococcus spp. -
Prevalence of Urinary Tract Infection and Antibiotic Resistance Pattern in Pregnant Women, Najran Region, Saudi Arabia
Vol. 13(26), pp. 407-413, August, 2019 DOI: 10.5897/AJMR2019.9084 Article Number: E3F64FA61643 ISSN: 1996-0808 Copyright ©2019 Author(s) retain the copyright of this article African Journal of Microbiology Research http://www.academicjournals.org/AJMR Full Length Research Paper Prevalence of urinary tract infection and antibiotic resistance pattern in pregnant women, Najran region, Saudi Arabia Ali Mohamed Alshabi1*, Majed Saeed Alshahrani2, Saad Ahmed Alkahtani1 and Mohammad Shabib Akhtar1 1Department of Clinical Pharmacy, College of Pharmacy, Najran University, Najran, Saudi Arabia. 2Department of Obstetics and Gyneocology, Faculty of Medicine, Najran University, Najran, Saudi Arabia. Received 25 February, 2019; Accepted August 5, 2019 Urinary Tract Infection (UTI) is one of the commonest infectious disease in pregnancy, and in pregnancy we have very limited number of antibiotics to treat the UTI. This study was conducted on 151 patients who attended the gynecology clinic during the study period. Nineteen UTI proven cases of UTI were studied for prevalence of microorganism and sensitivity pattern against different antibiotics. Among the bacteria isolated, Escherichia coli (73.68%) and Staphylococcus aureus (10.52%) were the most prevalent Gram negative and Gram positive bacteria respectively. To know the resistance pattern of microorganism we used commercially available discs of different antibiotics. Gram negative bacteria showed more resistance as compared to Gram positive one. It is observed that the most effective antibiotic for Gram negative isolates is Ceftriaxone (87.5%), followed by Amoxicillin + Clavulanic acid (81.25%), Amikacin (75%), Cefuroxime (75%), Cefixime (68.75%) and Mezlocillin (62.5%). For the Gram positive bacteria, Ceftriaxone, Amikacin and Amoxicillin + Clavulanic acid were the most effective antimicrobials (100%). -
Mechanisms of Resistance to P-Lactam Antibiotics Amongst 1993
J. Med. Microbiol. - Vol. 43 (1999, 30G309 0 1995 The Pathological Society of Great Britain and Ireland ANTI MICROBIAL AGENTS Mechanisms of resistance to p-lactam antibiotics amongst Pseudomonas aeruginosa isolates collected in the UK in 1993 H. Y. CHEN, ME1 YUAN and D. M. LIVERMORE Department of Medical Microbiology, The London Hospital Medical College, Turner Street, London El 2AD Summary. Antimicrobial resistance among 199 1 Pseudomonas aeruginosa isolates collected at 24 UK hospitals during late 1993 was surveyed. Three-hundred and seventy-two of the isolates were resistant, or had reduced susceptibility, to some or all of azlocillin, carbenicillin, ceftazidime, imipenem and meropenem, and the mechanisms underlying their behaviour were examined. Only 13 isolates produced secondary p-lactamases : six possessed PSE- 1 or PSE-4 enzymes and seven had novel OXA enzyme types. Those with PSE types were highly resistant to azlocillin and carbenicillin whereas those with OXA enzymes were less resistant to these penicillins. Chromosomal p-lactamase derepression was demonstrated in 54 isolates, most of which were resistant to ceftazidime and azlocillin although susceptible to carbenicillin and carbapenems. p-Lactamase-independent “ intrinsic” resistance occurred in 277 isolates and is believed to reflect some combination of impermeability and efflux. Two forms were seen : the classical type, present in 195 isolates, gave carbenicillin resistance (MIC > 128 mg/L) and reduced susceptibility to ciprofloxacin and to all p-lactam agents except imipenem; a novel variant, seen in 82 isolates, affected only azlocillin, ceftazidime and, to a small extent, meropenem. Resistance to imipenem was largely dissociated from that to other p-lactam agents, and probably reflected loss of D2 porin, whereas resistance to meropenem was mostly associated with intrinsic resistance to penicillins and cephalosporins. -
Severe Sepsis Tipsheet
Severe Sepsis Tipsheet SEVERE SEPSIS A, B, and C of the following must be met within 6 hours of each other. A. Documentation of a suspected infection. There may be reference to “possible infection,” “suspect infection,” “rule out infection,” or similar documentation. B. TWO or more manifestations of systemic infection according to the Systemic Inflammatory Response Syndrome (SIRS) criteria, which are: • Temperature > 38.3 C or < 36.0 C (> 100.9 F or < 96.8 F) • Heart rate (pulse) > 90 • Respiration > 20 per minute • White blood cell count > 12,000 or < 4,000 or > 10% bands C. Organ dysfunction, evidenced by any one of the following: • Systolic blood pressure (SBP) < 90 mmHg, or mean arterial pressure < 65 mmHg, or a systolic blood pressure decrease of more than 40 mmHg. Physician/APN/PA documentation must be present in the medical record indicating a > 40 mmHg decrease in SBP has occurred and is related to infection, severe sepsis or septic shock and not other causes. • Acute respiratory failure as evidenced by a new need for invasive or non-invasive mechanical ventilation. To use acute respiratory failure as a sign of organ dysfunction there must be: • Documentation of acute respiratory failure AND • Documentation the patient is on mechanical ventilation • Invasive mechanical ventilation requires an endotracheal or tracheostomy tube. Non-invasive mechanical ventilation may be referred to as BiPAP or CPAP. • New need for mechanical ventilation indicates the patient was not using the same type of mechanical ventilation prior to the current acute respiratory failure. • Use the time at which there is documentation the patient has both acute respiratory failure and is on mechanical ventilation. -
Below Are the CLSI Breakpoints for Selected Bacteria. Please Use Your Clinical Judgement When Assessing Breakpoints
Below are the CLSI breakpoints for selected bacteria. Please use your clinical judgement when assessing breakpoints. The lowest number does NOT equal most potent antimicrobial. Contact Antimicrobial Stewardship for drug selection and dosing questions. Table 1: 2014 MIC Interpretive Standards for Enterobacteriaceae (includes E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia and Proteus spp) Antimicrobial Agent MIC Interpretive Criteria (g/mL) Enterobacteriaceae S I R Ampicillin ≤ 8 16 ≥ 32 Ampicillin-sulbactam ≤ 8/4 16/8 ≥ 32/16 Aztreonam ≤ 4 8 ≥ 16 Cefazolin (blood) ≤ 2 4 ≥ 8 Cefazolin** (uncomplicated UTI only) ≤ 16 ≥ 32 Cefepime* ≤ 2 4-8* ≥ 16 Cefotetan ≤ 16 32 ≥ 64 Ceftaroline ≤ 0.5 1 ≥ 2 Ceftazidime ≤ 4 8 ≥ 16 Ceftriaxone ≤ 1 2 ≥ 4 Cefpodoxime ≤ 2 4 ≥ 8 Ciprofloxacin ≤ 1 2 ≥ 4 Ertapenem ≤ 0.5 1 ≥ 2 Fosfomycin ≤ 64 128 ≥256 Gentamicin ≤ 4 8 ≥ 16 Imipenem ≤ 1 2 ≥ 4 Levofloxacin ≤ 2 4 ≥ 8 Meropenem ≤ 1 2 ≥ 4 Piperacillin-tazobactam ≤ 16/4 32/4 – 64/4 ≥ 128/4 Trimethoprim-sulfamethoxazole ≤ 2/38 --- ≥ 4/76 *Susceptibile dose-dependent – see chart below **Cefazolin can predict results for cefaclor, cefdinir, cefpodoxime, cefprozil, cefuroxime axetil, cephalexin and loracarbef for uncomplicated UTIs due to E.coli, K.pneumoniae, and P.mirabilis. Cefpodoxime, cefinidir, and cefuroxime axetil may be tested individually because some isolated may be susceptible to these agents while testing resistant to cefazolin. Cefepime dosing for Enterobacteriaceae ( E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia & Proteus spp) Susceptible Susceptible –dose-dependent (SDD) Resistant MIC </= 2 4 8 >/= 16 Based on dose of: 1g q12h 1g every 8h or 2g every 8 h Do not give 2g q12 Total dose 2g 3-4g 6g NA Table 2: 2014 MIC Interpretive Standards for Pseudomonas aeruginosa and Acinetobacter spp. -
Antibacterial Drug Usage Analysis
Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Drug Use Review Date: April 5, 2012 To: Edward Cox, M.D. Director Office of Antimicrobial Products Through: Gerald Dal Pan, M.D., MHS Director Office of Surveillance and Epidemiology Laura Governale, Pharm.D., MBA Deputy Director for Drug Use Division of Epidemiology II Office of Surveillance and Epidemiology Hina Mehta, Pharm.D. Drug Use Data Analysis Team Leader Division of Epidemiology II Office of Surveillance and Epidemiology From: Tracy Pham, Pharm.D. Drug Use Data Analyst Division of Epidemiology II Office of Surveillance and Epidemiology Drug Name(s): Systemic Antibacterial Drug Products Application Type/Number: Multiple Applicant/sponsor: Multiple OSE RCM #: 2012-544 **This document contains proprietary drug use data obtained by FDA under contract. The drug use data/information in this document has been cleared for public release.** 1 EXECUTIVE SUMMARY The Division of Epidemiology II is providing an update of the drug utilization data in terms of number of kilograms or international units of selected systemic antibacterial drug products sold from manufacturers to various retail and non-retail channels of distribution for years 2010-2011 as a surrogate for nationwide antibacterial drug use in humans. Propriety drug use databases licensed by the FDA were used to conduct this analysis. Data findings are as follows: During years 2010 and 2011, the majority of kilograms of selected systemic antibacterial drug products sold were to outpatient retail pharmacy settings. Approximately 3.28 million kilograms of selected systemic antibacterial drug products were sold during year 2010, and around 3.29 million kilograms were sold during year 2011. -
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. -
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). -
Management of Penicillin and Beta-Lactam Allergy
Management of Penicillin and Beta-Lactam Allergy (NB Provincial Health Authorities Anti-Infective Stewardship Committee, September 2017) Key Points • Beta-lactams are generally safe; allergic and adverse drug reactions are over diagnosed and over reported • Nonpruritic, nonurticarial rashes occur in up to 10% of patients receiving penicillins. These rashes are usually not allergic and are not a contraindication to the use of a different beta-lactam • The frequently cited risk of 8 to 10% cross-reactivity between penicillins and cephalosporins is an overestimate based on studies from the 1970’s that are now considered flawed • Expect new intolerances (i.e. any allergy or adverse reaction reported in a drug allergy field) to be reported after 0.5 to 4% of all antimicrobial courses depending on the gender and specific antimicrobial. Expect a higher incidence of new intolerances in patients with three or more prior medication intolerances1 • For type-1 immediate hypersensitivity reactions (IgE-mediated), cross-reactivity among penicillins (table 1) is expected due to similar core structure and/or major/minor antigenic determinants, use not recommended without desensitization • For type-1 immediate hypersensitivity reactions, cross-reactivity between penicillins (table 1) and cephalosporins is due to similarities in the side chains; risk of cross-reactivity will only be significant between penicillins and cephalosporins with similar side chains • Only type-1 immediate hypersensitivity to a penicillin manifesting as anaphylaxis, bronchospasm, -
Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update
Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update Aline Fuchsa, Julia Bielickia,b, Shrey Mathurb, Mike Sharlandb, Johannes N. Van Den Ankera,c a Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, Basel, Switzerland b Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, United Kingdom c Division of Clinical Pharmacology, Children’s National Health System, Washington, DC, USA WHO-Reviews 1 TABLE OF CONTENTS 1. INTRODUCTION ............................................................................................................................... 3 1.1. Aims ......................................................................................................................................... 3 1.2. Background ............................................................................................................................. 3 1.2.1. Definition and diagnosis ................................................................................................. 3 Neonatal Sepsis ............................................................................................................................... 3 Paediatric Sepsis ............................................................................................................................. 4 Community versus hospital acquired sepsis .................................................................................. 5 1.2.2. Microbiology .................................................................................................................. -
Efficacy of Different Types of Therapy for COVID-19
life Review Efficacy of Different Types of Therapy for COVID-19: A Comprehensive Review Anna Starshinova 1,*, Anna Malkova 2 , Ulia Zinchenko 3 , Dmitry Kudlay 4,5 , Anzhela Glushkova 6, Irina Dovgalyk 3, Piotr Yablonskiy 2,3 and Yehuda Shoenfeld 2,7,8 1 Almazov National Medical Research Centre, Head of the Research Department, 2 Akkuratov Str., 197341 Saint-Petersburg, Russia 2 Medical Department, Saint Petersburg State University, 199034 Saint-Petersburg, Russia; [email protected] (A.M.); [email protected] (P.Y.); [email protected] (Y.S.) 3 St. Petersburg Research Institute of Phthisiopulmonology, 199034 Saint-Petersburg, Russia; [email protected] (U.Z.); [email protected] (I.D.) 4 NRC Institute of Immunology FMBA of Russia, 115478 Moscow, Russia; [email protected] 5 Medical Department, I.M. Sechenov First Moscow State Medical University, 119435 Moscow, Russia 6 V.M. Bekhterev National Research Medical Center for Psychiatry and Neurology, 192019 Saint Petersburg, Russia; [email protected] 7 Ariel University, Kiryat HaMada 3, Ariel 40700, Israel 8 Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 5265601, Israel * Correspondence: [email protected]; Tel.: +7-9052043861 Citation: Starshinova, A.; Malkova, Abstract: A new coronavirus disease (COVID-19) has already affected millions of people in 213 coun- A.; Zinchenko, U.; Kudlay, D.; tries. The possibilities of treatment have been reviewed in recent publications but there are many Glushkova, A.; Dovgalyk, I.; controversial results and conclusions. An analysis of the studies did not reveal a difference in Yablonskiy, P.; Shoenfeld, Y. Efficacy mortality level between people treated with standard therapy, such as antiviral drugs and dexam- of Different Types of Therapy for ethasone, and new antiviral drugs/additional immune therapy.