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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. -
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. -
Evaluation of Pharmacodynamic Interactions Between Telavancin
Infect Dis Ther DOI 10.1007/s40121-016-0121-2 ORIGINAL RESEARCH Evaluation of Pharmacodynamic Interactions Between Telavancin and Aztreonam or Piperacillin/ Tazobactam Against Pseudomonas aeruginosa, Escherichia coli and Methicillin-Resistant Staphylococcus aureus Juwon Yim . Jordan R. Smith . Katie E. Barber . Jessica A. Hallesy . Michael J. Rybak Received: May 2, 2016 Ó The Author(s) 2016. This article is published with open access at Springerlink.com ABSTRACT Methods: In vitro one-compartment PK/PD models were run over 96 h simulating TLV Introduction: In clinical trials comparing 10 mg/kg every 48 h, ATM 500 mg every 8 h telavancin (TLV) with vancomycin for and PTZ continuous infusion 13.5 g over 24 h treatment of hospital-acquired pneumonia, alone and in combination against P. aeruginosa, TLV demonstrated lower clinical cure rates E. coli and methicillin-resistant S. aureus than vancomycin in patients who had mixed (MRSA). The efficacy of antimicrobials was gram-positive and -negative infections and were evaluated by plotting time-kill curves and concomitantly treated with either aztreonam calculating the reduction in log10 cfu/ml over (ATM) or piperacillin/tazobactam (PTZ). Here, 96 h. we investigated therapeutic interactions Results: Against both MRSA strains, TLV was between TLV and ATM or PTZ in an in vitro rapidly bactericidal at 4 h and maintained its pharmacokinetic/pharmacodynamic (PK/PD) activity over 96 h with no observed antagonism model under simulated reduced renal function by either ATM or PTZ. PTZ maintained conditions. bacteriostatic and bactericidal activities against Enhanced content To view enhanced content for this E. coli ATCC 25922 and clinical strain R1022 at article go to http://www.medengine.com/Redeem/ 96 h, whereas both strains regrew as soon as 22E4F0603737CC9F. -
Ceftaroline in Complicated Skin and Skin-Structure Infections
Infection and Drug Resistance Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Ceftaroline in complicated skin and skin-structure infections Paul O Hernandez1 Abstract: Ceftaroline is an advanced-generation cephalosporin antibiotic recently approved by Sergio Lema2 the US Food and Drug Administration for the treatment of complicated skin and skin-structure Stephen K Tyring3 infections (cSSSIs). This intravenous broad-spectrum antibiotic exerts potent bactericidal activity Natalia Mendoza2,4 by inhibiting bacterial cell wall synthesis. A high affinity for the penicillin-binding protein 2a (PBP2a) of methicillin-resistant Staphylococcus aureus (MRSA) makes the drug especially 1University of Texas School of Medicine at San Antonio, beneficial to patients with MRSA cSSSIs. Ceftaroline has proved in multiple well-conducted San Antonio, TX, 2Woodhull clinical trials to have an excellent safety and efficacy profile. In adjusted doses it is also recom- Medical and Mental Health Center, mended for patients with renal or hepatic impairment. Furthermore, the clinical effectiveness Brooklyn, NY, 3Department of Dermatology, University of Texas and high cure rate demonstrated by ceftaroline in cSSSIs, including those caused by MRSA Health Science Center at Houston, and other multidrug-resistant strains, warrants its consideration as a first-line treatment option 4 Houston, TX, USA; Department of for cSSSIs. This article reviews ceftaroline and its pharmacology, efficacy, and safety data to Dermatology, El -
Real-World Use of Telavancin in the Treatment of Osteomyelitis
Diagnostic Microbiology and Infectious Disease 95 (2019) 185–190 Contents lists available at ScienceDirect Diagnostic Microbiology and Infectious Disease journal homepage: www.elsevier.com/locate/diagmicrobio Real-world use of telavancin in the treatment of osteomyelitis Louis D. Saravolatz a,⁎, Kerry O. Cleveland b, Khalid Rikabi c, Ali Hassoun d, Joseph Reilly e, Leonard B. Johnson a, Cedric Spak f, Sharon Valenti a, Susan Szpunar a a Ascension-St John Hospital and Wayne State University School of Medicine, Grosse Pointe Woods, Michigan, USA b University of Tennessee, Mephis Tennessee, USA c Geographic Medicine Services of Biloxi, Biloxi, Mississippi, USA d Alabama Infectious Diseases Center, Huntsville, Alabama, USA e AtlantiCare Regional Medical Center, Pomona, NJ, USA f North Texas Disease Consultants, Dallas, Texas, USA article info abstract Article history: This is a retrospective analysis of patients with osteomyelitis who received telavancin at some time during their Received 30 November 2018 treatment course. The primary outcome was the percent of patients cured or improved at the end of telavancin Received in revised form 17 May 2019 therapy (EOTT). The secondary outcome was the percent of patients cured or improved three months after dis- Accepted 18 May 2019 continuation of telavancin therapy. There were 32 cases of osteomyelitis with methicillin-resistant Staphylococ- Available online 28 May 2019 cus aureus identified in 17 (56.7%), methicillin-sensitive Staphylococcus aureus 2(6.6%), coagulase negative Keywords: staphylococci 6 (20.0%) and other pathogens, 5 (16.7%). At EOTT, 87.5% of patients had their osteomyelitis Telavancin cured and 94.6% had the infection cured at three months after telavancin was completed. -
Prospects for New Antibiotics: a Molecule-Centered Perspective
The Journal of Antibiotics (2014) 67, 7–22 & 2014 Japan Antibiotics Research Association All rights reserved 0021-8820/14 www.nature.com/ja REVIEW ARTICLE Prospects for new antibiotics: a molecule-centered perspective Christopher T Walsh and Timothy A Wencewicz There is a continuous need for iterative cycles of antibiotic discovery and development to deal with the selection of resistant pathogens that emerge as therapeutic application of an antibiotic becomes widespread. A short golden age of antibiotic discovery from nature followed by a subsequent golden half century of medicinal chemistry optimization of existing molecular scaffolds emphasizes the need for new antibiotic molecular frameworks. We bring a molecule-centered perspective to the questions of where will new scaffolds come from, when will chemogenetic approaches yield useful new antibiotics and what existing bacterial targets merit contemporary re-examination. The Journal of Antibiotics (2014) 67, 7–22; doi:10.1038/ja.2013.49; published online 12 June 2013 Keywords: antibiotics; mechanism of action; natural products; resistance A PERSONAL PATHWAY TO ANTIBIOTICS RESEARCH chemical logic and molecular machinery and, in part, with the hope For one of us (CTW), a career-long interest in antibiotics1 was that one might learn to reprogram natural antibiotic assembly lines to spurred by discussions on the mechanism of action of engineer improved molecular variants. D-fluoroalanine2,3 during a seminar visit, as a second year assistant We have subsequently deciphered many of the rules -
Strategies in Stewardship and Why Some Antimicrobials Should Be Protected
Strategies in Stewardship and Why Some Antimicrobials Should Be Protected Matt Crotty, PharmD Clinical Pharmacist – Infectious Diseases Methodist Dallas Medical Center September 7, 2017 Disclosures • Acted as a consultant – Nabriva Therapeutics AG – Theravance Biopharma Objectives • Define antimicrobial stewardship • Discuss current and future strategies for antimicrobial stewardship to promote judicious use of antimicrobials • Describe the reasons for “protecting” antimicrobials Outline • The Problem • Antimicrobial stewardship – Concept – Strategies • Passive • Active • Other (…prevention would be nice) • Reasons antimicrobials are protected • Collaboration Misuse adversely impacts patients – Resistance “…. the microbes are educated to resist penicillin and a host of penicillin-fast organisms is bred out… In such cases the thoughtless person playing with penicillin is morally responsible for the death of the man who finally succumbs to infection with the penicillin-resistant organism. I hope this evil can be averted.” - Sir Alexander Fleming, June 1945 Nature Reviews: Drug Discovery. 2007: 6; 8-12. Antibiotics are misused in hospitals . An estimated 30-50% of antimicrobial use in hospitals is inappropriate . Misused in a variety of ways • Given when not needed • Continued when no longer necessary • Wrong dose/drug for infection • Broad spectrum for susceptible organisms IDSA Statement on ‘Antibiotic Resistance: Promoting Critically Needed Antibiotic Research and Development and Appropriate Use (“Stewardship”) of these Precious Drugs’ -Before the House Committee on Energy and Commerce Subcommittee on Health; June 9, 2010 Antibiotics are misused in hospitals CDC, MMWR. 2014; 63. Misuse adversely impacts patients – Adverse Effects . Perception that there is (almost) no risk and (almost) all benefit to giving an antibiotic . Antibiotics account for nearly 1 in 5 (19.3%) of drug-related adverse events • >140,000 ED visits/year • Admission required for 6.1% of adverse events . -
Outpatient Parenteral Antimicrobial Therapy for Infectious Diseases 3Ed
Outpatient Parenteral Antimicrobial Therapy Handbook of For Infectious Diseases 3ed The Sponsored by Medicines Company ©2016 CRG Publishing, a Division of The Curry Rockefeller Group, LLC, and the Infectious Diseases Society of America All rights reserved. No part of the OPAT eHandbook may be reproduced in any form by any means (eg, electronically, mechanically, copied, recorded, or otherwise), or utilized by any information storage or retrieval system, without the written permission of CRG Publishing and the Infectious Diseases Society of America. For information, contact Rights and Permissions Coordinator, The Curry Rockefeller Group, Suite 410, 660 White Plains Road, Tarrytown, New York, 10591, USA. The Sponsored by Medicines Company Supported by Handbook of Outpatient Parenteral Antimicrobial Therapy For Infectious Diseases 3ed Akshay B. Shah, MD, MBA, FIDSA Anne H. Norris, MD Chair, OPAT Workgroup of IDSA Co-Chair, OPAT Guidelines Committee of IDSA Metro Infectious Disease Consultants Associate Professor of Medicine Editors Clinical Assistant Professor Perelman School of Medicine, University of Pennsylvania Wayne State University Philadelphia, PA Detroit, MI CRG PUBLISHING, A DIVISION OF THE CURRY ROCKEFELLER GROUP, LLC Geneve M. Allison, MD, MSc, FACP Ajay Mathur, MD, FACP Akshay B. Shah, MD, MBA, FIDSA Assistant Professor Regional VP Chair, OPAT Workgroup of IDSA Tufts University School of Medicine ID Care Metro Infectious Disease Consultants Clinical Assistant Professor Antonio C. Arrieta, MD David S. McKinsey, MD Wayne State University Division Chief, Infectious Diseases Physician Children’s Hospital of Orange County Infectious Disease Associates of Kansas City Nabin Shrestha, MD, MPH, FACP, FIDSA Infectious Disease Physician Kavita P. Bhavan, MD Sandra B. -
Full Prescribing Information for Prolong Aptt for up to 120 Hours, and May Prolong PT and INR for up ORBACTIV
HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------WARNINGS AND PRECAUTIONS----------------------- These highlights do not include all the information needed to use • Coagulation test interference: ORBACTIV has been shown to artificially ORBACTIV safely and effectively. See full prescribing information for prolong aPTT for up to 120 hours, and may prolong PT and INR for up ORBACTIV. to 12 hours and ACT for up to 24 hours. For patients who require aPTT monitoring within 120 hours of ORBACTIV dosing, consider a ORBACTIV® (oritavancin) for injection, for intravenous use non-phospholipid dependent coagulation test such as a Factor Xa Initial U.S. Approval: 2014 (chromogenic) assay or an alternative anticoagulant not requiring aPTT. (5.1, 7.2) ----------------------------INDICATIONS AND USAGE--------------------------- • Serious hypersensitivity reactions, including anaphylaxis, have been ORBACTIV is a lipoglycopeptide antibacterial drug indicated for the reported with the use of oritavancin products, including ORBACTIV. treatment of adult patients with acute bacterial skin and skin structure Discontinue infusion if signs of acute hypersensitivity occur. Carefully infections caused or suspected to be caused by susceptible isolates of monitor patients with known hypersensitivity to glycopeptides. (5.2) designated Gram-positive microorganisms. (1.1) • Infusion Related Reactions: Administer ORBACTIV over 3 hours to minimize infusion. Infusion related reactions have been reported with To reduce the development of drug-resistant bacteria and maintain the the glycopeptide class of antimicrobial agents, including oritavancin effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV products (e.g. ORBACTIV). Stopping or slowing the infusion may result should be used only to treat or prevent infections that are proven or strongly in cessation of these reactions. -
Prospects for New Antibiotics: a Molecule-Centered Perspective
The Journal of Antibiotics (2014) 67, 7–22 & 2014 Japan Antibiotics Research Association All rights reserved 0021-8820/14 www.nature.com/ja REVIEW ARTICLE Prospects for new antibiotics: a molecule-centered perspective Christopher T Walsh and Timothy A Wencewicz There is a continuous need for iterative cycles of antibiotic discovery and development to deal with the selection of resistant pathogens that emerge as therapeutic application of an antibiotic becomes widespread. A short golden age of antibiotic discovery from nature followed by a subsequent golden half century of medicinal chemistry optimization of existing molecular scaffolds emphasizes the need for new antibiotic molecular frameworks. We bring a molecule-centered perspective to the questions of where will new scaffolds come from, when will chemogenetic approaches yield useful new antibiotics and what existing bacterial targets merit contemporary re-examination. The Journal of Antibiotics (2014) 67, 7–22; doi:10.1038/ja.2013.49; published online 12 June 2013 Keywords: antibiotics; mechanism of action; natural products; resistance A PERSONAL PATHWAY TO ANTIBIOTICS RESEARCH chemical logic and molecular machinery and, in part, with the hope For one of us (CTW), a career-long interest in antibiotics1 was that one might learn to reprogram natural antibiotic assembly lines to spurred by discussions on the mechanism of action of engineer improved molecular variants. D-fluoroalanine2,3 during a seminar visit, as a second year assistant We have subsequently deciphered many of the rules -
Telavancin Activity Tested Against Gram-Positive Clinical Isolates
TN004-14 ECCMID 14_JMI 11_12 EU lc14_Layout 1 24/04/2014 17:44 Page 1 Poster P1579 Contact information: Rodrigo E. Mendes , PhD Telavancin Activity Tested Against Gram-Positive Clinical Isolates From European Hospitals (2011 –2013) JMI Laboratories 345 Beaver Kreek Ctr, Ste A Using A Revised Broth Microdilution Testing Method: Redefining the Baseline Activity for Telavancin North Liberty, Iowa 52317 USA Phone: 319-665-3370 Fax: 319-665-3371 Rodrigo E. Mendes*, David J. Farrell, Jennifer M. Streit , Ronald N. Jones E-mail: [email protected] JMI Laboratories, North Liberty, Iowa, USA Table 1. Antimicrobial activity and MIC distribution for telavancin when tested against 11 ,601 contemporary (2011 –2013) clinical isolates from European and adjacent countries , as part of the international telavancin surveillance programme • This revised reference method for telavancin resembles those utilised for other lipoglycopeptide Table 2. Antimicrobial activity of telavancin and comparator agents tested against Gram-positive clinical isolates from European and ABSTRACT MIC (mg/L) Number (cumulative %) inhibited at telavancin MIC (mg/L) b agents, such as dalbavancin and oritavancin .5,6 adjacent countries , as part of the 2011 –2013 international telavancin surveillance programme a Organism (no. tested) 50% 90% ≤0.015 0.03 0.06 0.12 0.25 0.5 1 >1 a MIC (mg/L ) %Susceptible/%Intermediate/Resistant b Objectives : To reassess the activity of telavancin when tested against clinical isolates recovered from • The susceptibility testing methods for these agents also incorporate P-80, which was shown to be Organism (no. tested)/ MSSA (4108) 0.03 0.06 157 (3.8) 2514 (65.0) 1430 (99.8) 7 (100.0) Antimicrobial agent Range 50% 90% CLSI EUCAST hospitalised patients in European and adjacent countries.