Expanded Antimicrobial Susceptibility Testing for Hard-To-Treat Infections
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Formerly VNRX-5133) Against a 2122 Palmer Drive 02581 Schaumburg, IL 60173 USA European 2018-2020 Surveillance Collection of Pseudomonas Aeruginosa
IHMA, Inc. Antimicrobial Activity of Cefepime in Combination with Taniborbactam (formerly VNRX-5133) Against a 2122 Palmer Drive 02581 Schaumburg, IL 60173 USA European 2018-2020 Surveillance Collection of Pseudomonas aeruginosa www.ihma.com M. Hackel1, M. Wise1, D. Sahm1 1IHMA, Inc., Schaumburg, IL, USA INTRODUCTION RESULTS RESULTS SUMMARY Taniborbactam, (formerly VNRX-5133), is a Table 1. In vitro activity of cefepime-taniborbactam and Figure 1. MIC distribution of cefepime, cefepime-taniborbactam, and comparators Figure 3. MIC distribution of cefepime, cefepime-taniborbactam, and comparators . Cefepime-taniborbactam demonstrated potent in vitro activity novel cyclic boronate-based broad-spectrum β- comparator agents against 2,035 P. aeruginosa from against 2,035 Pseudomonas aeruginosa from Europe against 595 meropenem-non-susceptible Pseudomonas aeruginosa from Europe (MIC50/90, 2/8 mg/L; 95.6% inhibited at ≤8 mg/L) against P. lactamase inhibitor with potent and selective Europe aeruginosa isolates from Europe (Table 1). direct inhibitory activity against both serine- and Phenotype (n; percent of total) Antimicrobial %S %I* %R MIC50 MIC90 . Provisional susceptibility rates to cefepime-taniborbactam and All (2,035) Cefepime-taniborbactam 95.6 -- 4.4 2 8 Cefepime (FEP) metallo-β-lactamases (Ambler Classes A, B, C Cefepime 0.0 79.0 21.0 4 32 Cefepime (FEP) Ceftazidime 0.0 75.8 24.2 4 >32 Cefepime-taniborbactam (FTB) FTB 86.6% ≤8 µg/mL ceftolozane-tazobactam, respectively, were 73.2% and 13.2% vs and D). Taniborbactam greatly enhances -
Ceftazidime for Injection) PHARMACY BULK PACKAGE – NOT for DIRECT INFUSION
PRESCRIBING INFORMATION FORTAZ® (ceftazidime for injection) PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4 thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1 azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure: The molecular formula is C22H32N6O12S2, representing a molecular weight of 636.6. FORTAZ is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. The Pharmacy Bulk Package vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3mEq) per gram of ceftazidime. FORTAZ in sterile crystalline form is supplied in Pharmacy Bulk Packages equivalent to 6g of anhydrous ceftazidime. The Pharmacy Bulk Package bottle is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous use. THE PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION, FURTHER DILUTION IS REQUIRED BEFORE USE. -
Activity of Aztreonam in Combination with Ceftazidime-Avibactam Against
Diagnostic Microbiology and Infectious Disease 99 (2021) 115227 Contents lists available at ScienceDirect Diagnostic Microbiology and Infectious Disease journal homepage: www.elsevier.com/locate/diagmicrobio Activity of aztreonam in combination with ceftazidime–avibactam against serine- and metallo-β-lactamase–producing ☆ ☆☆ ★ Pseudomonas aeruginosa , , Michelle Lee a, Taylor Abbey a, Mark Biagi b, Eric Wenzler a,⁎ a College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA b College of Pharmacy, University of Illinois at Chicago, Rockford, IL, USA article info abstract Article history: Existing data support the combination of aztreonam and ceftazidime–avibactam against serine-β-lactamase Received 29 June 2020 (SBL)– and metallo-β-lactamase (MBL)–producing Enterobacterales, although there is a paucity of data against Received in revised form 15 September 2020 SBL- and MBL-producing Pseudomonas aeruginosa. In this study, 5 SBL- and MBL-producing P. aeruginosa (1 Accepted 19 September 2020 IMP, 4 VIM) were evaluated against aztreonam and ceftazidime–avibactam alone and in combination via broth Available online xxxx microdilution and time-kill analyses. All 5 isolates were nonsusceptible to aztreonam, aztreonam–avibactam, – – Keywords: and ceftazidime avibactam. Combining aztreonam with ceftazidime avibactam at subinhibitory concentrations Metallo-β-lactamase produced synergy and restored bactericidal activity in 4/5 (80%) isolates tested. These results suggest that the VIM combination of aztreonam and ceftazidime–avibactam may be a viable treatment option against SBL- and IMP MBL-producing P. aeruginosa. Aztreonam © 2020 Elsevier Inc. All rights reserved. Ceftazidime–avibactam Synergy 1. Introduction of SBLs and MBLs harbored by P. aeruginosa are fundamentally different than those in Enterobacterales (Alm et al., 2015; Kazmierczak et al., The rapid global dissemination of Ambler class B metallo-β- 2016; Periasamy et al., 2020; Poirel et al., 2000; Watanabe et al., lactamase (MBL) enzymes along with their increasing diversity across 1991). -
Pharmacodynamic Evaluation of Suppression of in Vitro Resistance In
www.nature.com/scientificreports OPEN Pharmacodynamic evaluation of suppression of in vitro resistance in Acinetobacter baumannii strains using polymyxin B‑based combination therapy Nayara Helisandra Fedrigo1, Danielle Rosani Shinohara1, Josmar Mazucheli2, Sheila Alexandra Belini Nishiyama1, Floristher Elaine Carrara‑Marroni3, Frederico Severino Martins4, Peijuan Zhu5, Mingming Yu6, Sherwin Kenneth B. Sy2 & Maria Cristina Bronharo Tognim1* The emergence of polymyxin resistance in Gram‑negative bacteria infections has motivated the use of combination therapy. This study determined the mutant selection window (MSW) of polymyxin B alone and in combination with meropenem and fosfomycin against A. baumannii strains belonging to clonal lineages I and III. To evaluate the inhibition of in vitro drug resistance, we investigate the MSW‑derived pharmacodynamic indices associated with resistance to polymyxin B administrated regimens as monotherapy and combination therapy, such as the percentage of each dosage interval that free plasma concentration was within the MSW (%TMSW) and the percentage of each dosage interval that free plasma concentration exceeded the mutant prevention concentration (%T>MPC). The MSW of polymyxin B varied between 1 and 16 µg/mL for polymyxin B‑susceptible strains. The triple combination of polymyxin B with meropenem and fosfomycin inhibited the polymyxin B‑resistant subpopulation in meropenem‑resistant isolates and polymyxin B plus meropenem as a double combination sufciently inhibited meropenem‑intermediate, and susceptible strains. T>MPC 90% was reached for polymyxin B in these combinations, while %TMSW was 0 against all strains. TMSW for meropenem and fosfomycin were also reduced. Efective antimicrobial combinations signifcantly reduced MSW. The MSW‑derived pharmacodynamic indices can be used for the selection of efective combination regimen to combat the polymyxin B‑resistant strain. -
Global Assessment of the Antimicrobial Activity of Polymyxin B Against 54 731 Clinical Isolates of Gram-Negative Bacilli
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector ORIGINAL ARTICLE 10.1111/j.1469-0691.2005.01351.x Global assessment of the antimicrobial activity of polymyxin B against 54 731 clinical isolates of Gram-negative bacilli: report from the SENTRY antimicrobial surveillance programme (2001–2004) A. C. Gales1, R. N. Jones2,3 and H. S. Sader1,2 1Division of Infectious Diseases, Universidade Federal de Sa˜o Paulo, Sa˜o Paulo, Brazil, 2JMI Laboratories, North Liberty, IA, USA, and 3Tufts University School of Medicine, Boston, MA, USA ABSTRACT In total, 54 731 Gram-negative bacilli isolated worldwide between 2001 and 2004 from diverse sites of infection were tested for susceptibility to polymyxin B by the broth reference microdilution method, with interpretation of results according to CLSI (formerly NCCLS) guidelines. Polymyxin B showed excellent potency and spectrum against 8705 Pseudomonas aeruginosa and 2621 Acinetobacter spp. isolates (MIC50, £ ⁄ ⁄ 1mg L and MIC90,2mg L for both pathogens). Polymyxin B resistance rates were slightly higher for carbapenem-resistant P. aeruginosa (2.7%) and Acinetobacter spp. (2.8%), or multidrug-resistant (MDR) P. aeruginosa (3.3%) and Acinetobacter spp. (3.2%), when compared with the entire group (1.3% for P. aeruginosa and 2.1% for Acinetobacter spp.). Among P. aeruginosa, polymyxin B resistance rates varied from 2.9% in the Asia-Pacific region to only 1.1% in Europe, Latin America and North America, while polymyxin B resistance rates ranged from 2.7% in Europe to 1.7% in North America and Latin America £ ⁄ % among Acinetobacter spp. -
FDA Drug Safety Communication: FDA Cautions About Dose Confusion and Medication Error with Antibacterial Drug Avycaz (Ceftazidime and Avibactam)
FDA Drug Safety Communication: FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam) Safety Announcement [09-22-2015] The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, we have revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram (see Photos). Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness. Since Avycaz’s approval in February 2015, we have received reports of three medication error cases related to confusion on how the strength was displayed on the Avycaz vial and carton labels. Two cases stated that the errors occurred during preparation of the dose in the pharmacy. The third case described concern about the potential for confusion because the strength displayed for Avycaz differs from how the strength is displayed for other beta-lactam/beta-lactamase antibacterial drugs. -
A Phase I, 3-Part Placebo-Controlled Randomised Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Aztreonam-Av
EV0643 Contactinformation: A phase I, 3-part placebo-controlled randomised trial to evaluate the safety, SeamusO’Brien AstraZenecaResearch&Development Macclesfield,Cheshire,UK tolerability and pharmacokinetics of aztreonam-avibactam in healthy subjects [email protected] Timi Edeki1, Diansong Zhou2, Frans van den Berg3, Helen Broadhurst4, William C. Holmes5, Gary Peters3, Maria Sunzel6, Seamus O’Brien4 1AstraZeneca, Wilmington, DE, USA; 2AstraZeneca, Waltham, MA, USA; 3Hammersmith Medicines Research, London, UK; 4AstraZeneca, Macclesfield, UK; 5AstraZeneca, Gaithersburg, MD, USA; 6Contractor at AstraZeneca, Wilmington, DE, USA Background Table 1.Subjects’baselinecharacteristics Figure 1. Geometricmean(A)aztreonamand(B)avibactamconcentration-timeprofilesinPartAfollowingindividualandcombinedadministrationofaztreonam2000mgandavibactam600mgby1-hIVinfusion Part A Part B Part C • Theemergenceandglobaldisseminationofmetallo-β-lactamase(MBL)-producing (A) (B) Enterobacteriaceae,includingNDM-typeandVIM-type,whichareresistanttocarbapenems, Active Placebo Active Placebo Active Placebo 100 Aztreonam 2000 mg alone (n=7) 100 Avibactam 600 mg alone (n=8) representsanurgentthreattohumanhealthforwhichfewtreatmentoptionscurrentlyexist.1, 2 (n=8) (n=4) (n=40) (n=16) (n=18) (n=6) Aztreonam-avibactam 2000-600 mg (n=7) Aztreonam-avibactam 2000-600 mg (n=7) • Aztreonam,amonobactamβ-lactam,isstabletoAmblerclassBMBLsincludingNDM-typeand Mean(SD)age,years 31(7) 34(7) 30(7) 27(5) 49(19) 51(19) VIM-type.However,bacteriathatexpressMBLsfrequentlyco-expressotherclassesofβ-lactamase -
General Items
Essential Medicines List (EML) 2019 Application for the inclusion of imipenem/cilastatin, meropenem and amoxicillin/clavulanic acid in the WHO Model List of Essential Medicines, as reserve second-line drugs for the treatment of multidrug-resistant tuberculosis (complementary lists of anti-tuberculosis drugs for use in adults and children) General items 1. Summary statement of the proposal for inclusion, change or deletion This application concerns the updating of the forthcoming WHO Model List of Essential Medicines (EML) and WHO Model List of Essential Medicines for Children (EMLc) to include the following medicines: 1) Imipenem/cilastatin (Imp-Cln) to the main list but NOT the children’s list (it is already mentioned on both lists as an option in section 6.2.1 Beta Lactam medicines) 2) Meropenem (Mpm) to both the main and the children’s lists (it is already on the list as treatment for meningitis in section 6.2.1 Beta Lactam medicines) 3) Clavulanic acid to both the main and the children’s lists (it is already listed as amoxicillin/clavulanic acid (Amx-Clv), the only commercially available preparation of clavulanic acid, in section 6.2.1 Beta Lactam medicines) This application makes reference to amendments recommended in particular to section 6.2.4 Antituberculosis medicines in the latest editions of both the main EML (20th list) and the EMLc (6th list) released in 2017 (1),(2). On the basis of the most recent Guideline Development Group advising WHO on the revision of its guidelines for the treatment of multidrug- or rifampicin-resistant (MDR/RR-TB)(3), the applicant considers that the three agents concerned be viewed as essential medicines for these forms of TB in countries. -
P1157 Searching for Optimal Treatment Regimens For
P1157 Searching for optimal treatment regimens for Stenotrophomonas maltophilia resistant to levofloxacin and/or sulfamethoxazole-trimethoprim: aztreonam in combination with avibactam or vaborbactam Mark Biagi*1, Samah Qasmieh1, Denise Lamm1, Kevin Meyer1, Tiffany Wu1, Eric Wenzler1 1 Pharmacy Practice, University of Illinois at Chicago, Chicago, United States Background: Current preferred treatment options for Stenotrophomonas maltophilia include sulfamethoxazole- trimethoprim and levofloxacin but their use may be compromised by increasing reports of resistance, toxicities, and drug interactions. Among the β-lactams, only aztreonam is able to evade S. maltophilia’s L1 metallo-β- lactamase-mediated hydrolysis but it remains prone to hydrolysis by the L2 serine β-lactamase, effectively rendering all β-lactams ineffective. Combining aztreonam with a β-lactamase inhibitor with activity against L2 may restore aztreonam’s activity and offer clinicians a novel treatment option. Materials/methods: MICs for 37 clinical S. maltophilia isolates resistant to levofloxacin and/or sulfamethoxazole- trimethoprim were tested in triplicate via broth microdilution method according to CLSI guidelines. Modal MICs are reported. Susceptibility interpretations were based on CLSI breakpoints for levofloxacin and sulfamethoxazole- trimethoprim against S. maltophilia and against Pseudomonas aeruginosa for aztreonam-based regimens. Time kill analyses were performed in triplicate for 5 isolates at standard inoculum (106) for aztreonam, aztreonam/avibactam, and aztreonam/vaborbactam at either fCmax or ¼, ½, 1, 2, or 4x MIC. Bactericidal activity was considered a ≥3 log10 reduction in CFU/mL from the starting inoculum. Synergy was ≥2 log10 reduction in CFU/mL compared to the most active agent alone. Results: Susceptibilities are summarized in Table 1. 97% (36/37) of isolates were resistant to aztreonam. -
12. What's Really New in Antibiotic Therapy Print
What’s really new in antibiotic therapy? Martin J. Hug Freiburg University Medical Center EAHP Academy Seminars 20-21 September 2019 Newsweek, May 24-31 2019 Disclosures There are no conflicts of interest to declare EAHP Academy Seminars 20-21 September 2019 Antiinfectives and Resistance EAHP Academy Seminars 20-21 September 2019 Resistance of Klebsiella pneumoniae to Pip.-Taz. olates) EAHP Academy Seminars 20-21 September 2019 https://resistancemap.cddep.org/AntibioticResistance.php Multiresistant Pseudomonas Aeruginosa Combined resistance against at least three different types of antibiotics, 2017 EAHP Academy Seminars 20-21 September 2019 https://atlas.ecdc.europa.eu/public/index.aspx Distribution of ESBL producing Enterobacteriaceae EAHP Academy Seminars 20-21 September 2019 Rossolini GM. Global threat of Gram-negative antimicrobial resistance. 27th ECCMID, Vienna, 2017, IS07 Priority Pathogens Defined by the World Health Organisation Critical Priority High Priority Medium Priority Acinetobacter baumanii Enterococcus faecium Streptococcus pneumoniae carbapenem-resistant vancomycin-resistant penicillin-non-susceptible Pseudomonas aeruginosa Helicobacter pylori Haemophilus influenzae carbapenem-resistant clarithromycin-resistant ampicillin-resistant Enterobacteriaceae Salmonella species Shigella species carbapenem-resistant fluoroquinolone-resistant fluoroquinolone-resistant Staphylococcus aureus vancomycin or methicillin -resistant Campylobacter species fluoroquinolone-resistant Neisseria gonorrhoae 3rd gen. cephalosporin-resistant -
Severe Sepsis and Septic Shock Antibiotic Guide
Stanford Health Issue Date: 05/2017 Stanford Antimicrobial Safety and Sustainability Program Severe Sepsis and Septic Shock Antibiotic Guide Table 1: Antibiotic selection options for healthcare associated and/or immunocompromised patients • Healthcare associated: intravenous therapy, wound care, or intravenous chemotherapy within the prior 30 days, residence in a nursing home or other long-term care facility, hospitalization in an acute care hospital for two or more days within the prior 90 days, attendance at a hospital or hemodialysis clinic within the prior 30 days • Immunocompromised: Receiving chemotherapy, known systemic cancer not in remission, ANC <500, severe cell-mediated immune deficiency Table 2: Antibiotic selection options for community acquired, immunocompetent patients Table 3: Antibiotic selection options for patients with simple sepsis, community acquired, immunocompetent patients requiring hospitalization. Risk Factors for Select Organisms P. aeruginosa MRSA Invasive Candidiasis VRE (and other resistant GNR) Community acquired: • Known colonization with MDROs • Central venous catheter • Liver transplant • Prior IV antibiotics within 90 day • Recent MRSA infection • Broad-spectrum antibiotics • Known colonization • Known colonization with MDROs • Known MRSA colonization • + 1 of the following risk factors: • Prolonged broad antibacterial • Skin & Skin Structure and/or IV access site: ♦ Parenteral nutrition therapy Hospital acquired: ♦ Purulence ♦ Dialysis • Prolonged profound • Prior IV antibiotics within 90 days ♦ Abscess -
Antimicrobial Surgical Prophylaxis
Antimicrobial Surgical Prophylaxis The antimicrobial surgical prophylaxis protocol establishes evidence-based standards for surgical prophylaxis at The Nebraska Medical Center. The protocol was adapted from the recently published consensus guidelines from the American Society of Health-System Pharmacists (ASHP), Society for Healthcare Epidemiology of America (SHEA), Infectious Disease Society of America (IDSA), and the Surgical Infection Society (SIS) and customized to Nebraska Medicine with the input of the Antimicrobial Stewardship Program in concert with the various surgical groups at the institution. The protocol established here-in will be implemented via standard order sets utilized within One Chart. Routine surgical prophylaxis and current and future surgical order sets are expected to conform to this guidance. Antimicrobial Surgical Prophylaxis Initiation Optimal timing: Within 60 minutes before surgical incision o Exceptions: Fluoroquinolones and vancomycin (within 120 minutes before surgical incision) Successful prophylaxis necessitates that the antimicrobial agent achieve serum and tissue concentrations above the MIC for probable organisms associated with the specific procedure type at the time of incision as well as for the duration of the procedure. Renal Dose Adjustment Guidance The following table can be utilized to determine if adjustments are needed to antimicrobial surgical prophylaxis for both pre-op and post-op dosing. Table 1 Renal Dosage Adjustment Dosing Regimen with Dosing Regimen with CrCl Dosing Regimen with