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IDWEEK 2013 Ceftaroline BSI 758.Pdf Helio S. Sader, MD, PhD Antimicrobial Activity of Ceftaroline and Comparator Agents Tested Against Bacterial JMI Laboratories IDWEEK 2013 North Liberty, IA, USA Isolates from Patients with Bacteremia in United States Medical Centers (2012) www.jmilabs.com 758 ph. 319.665.3370 HS SADER, RK FLAMM, RN JONES fax 319.665.3371 JMI Laboratories, North Liberty, Iowa, USA [email protected] Staphylococcus aureus, especially oxacillin (methicillin)-resistant Table 2. Activity of ceftaroline and comparator antimicrobial agents when tested against bacterial isolates Abstract strains (MRSA), represents a major cause of BSI, and prompt Results causing blood stream infections in USA medical centers (2012) Conclusions and appropriate antibacterial therapy plays an important role in MIC (µg/mL) MIC (µg/mL) MIC (µg/mL) Background: Ceftaroline (CPT), the active metabolite of the • Ceftaroline was very active against S. aureus overall (MIC , 0.25/1 μg/mL; 96.6% susceptible), including Organism (no. tested) / %S / % I / %R Organism (no. tested) / %S / % I / %R Organism (no. tested) / %S / % I / %R • Ceftaroline demonstrated potent activity against the management of MRSA infections. Vancomycin has been 50/90 Antimicrobial agent (CLSI)a Antimicrobial agent (CLSI)a Antimicrobial agent (CLSI)a 50% 90% 50% 90% 50% 90% prodrug CPT fosamil, is a cephalosporin with potent activity used for treatment of MRSA infections for more than 40 years, 45.6% of isolates that were MRSA gram-positive organisms, including MRSA and Staphylococcus aureus (1,014) β-hemolytic streptococcif (164) Enterobacter cloacae (109) against methicillin-resistant S. aureus (MRSA). CPT fosamil ceftriaxone-non-susceptible S. pneumoniae strains, and although susceptibility rates remain high (>99%) in the Ceftaroline 0.25 1 96.6 / 3.4 / 0.0 Ceftaroline ≤0.015 ≤0.015 - / - / - Ceftaroline 0.25 >32 66.1 / 2.7 / 31.2 was approved by the United States (USA) Food and Drug • Ceftaroline MIC values ranged from 0.12 to 2 μg/mL when tested against MRSA (MIC50 and MIC90, 1 μg/mL) United States (USA) and worldwide, there have been increasing Ceftriaxone 4 >8 54.4 / 0.0 / 45.6 Ceftriaxone ≤0.06 0.12 100.0 / - / - Ceftriaxone 0.5 >8 67.9 / 2.7 / 29.4 and non-ESBL-phenotype Enterobacteriaceae Administration in 2010. CPT and comparators were tested and 92.6% were inhibited at ceftaroline MIC of ≤1 μg/mL (Tables 1 and 2) reports of treatment failure, which could be related to increased Oxacillin 0.5 >2 54.4 / 0.0 / 45.6 Penicillin ≤0.06 ≤0.06 100.0 / - / - Ceftazidime 0.5 >32 73.4 / 3.7 / 22.9 causing BSI in USA hospitals against contemporary pathogens causing bacteremia in USA Erythromycin 16 >16 43.3 / 2.9 / 53.8 Erythromycin ≤0.12 >16 59.8 / 1.2 / 39.0 Piperacillin/tazobactam 4 64 81.7 / 10.0 / 8.3 vancomycin MIC occurrences within the susceptibility range (2 • When tested against oxacillin- (methicillin)-susceptible S. aureus (MSSA), ceftaroline (MIC50 and MIC90, hospitals. Clindamycin ≤0.25 >2 81.6 / 0.2 / 18.3 Clindamycin ≤0.25 >2 75.6 / 0.7 / 23.8 Meropenem ≤0.06 ≤0.06 100.0 / 0.0 / 0.0 µg/mL). 0.25 μg/mL; highest MIC, 0.5 µg/mL) was 16-fold more active than ceftriaxone (MIC50 and MIC90, 4 μg/mL) Levofloxacin 0.25 >4 58.7 / 1.1 / 40.2 Levofloxacin 0.5 1 99.4 / 0.6 / 0.0 Levofloxacin ≤0.12 0.5 99.1 / 0.9 / 0.0 • These in vitro data support the further clinical Methods: 3,590 organisms from the 2012 AWARE CPT and four- to eight-fold more active than linezolid (MIC50/90, 1/2 μg/mL) and vancomycin (MIC50 and MIC90, 1 Tigecyclineb 0.06 0.12 100.0 / - / - Linezolid 1 1 100.0 / - / - Gentamicin ≤1 ≤1 96.3 / 0.0 / 3.7 development of ceftaroline for treatment of BSI, surveillance program were isolated from patients with Ceftaroline fosamil is approved by the USA Food and Drug μg/mL; Table 2) Linezolid 1 1 100.0 / 0.0 / 0.0 Tigecyclineb 0.03 0.03 100.0 / - / - Tigecyclineb 0.25 1 97.2 / 2.8 / 0.0 especially those caused by MRSA and multidrug- bacteremia. Pathogens were collected in 163 medical Vancomycin 1 1 99.9 / 0.1 / 0.0 Vancomycin 0.5 0.5 100.0 / - / - Enterobacter aerogenes (41) Administration (FDA) for the treatment of acute bacterial skin Daptomycin 0.25 0.5 100.0 / - / - Daptomycin 0.12 0.25 100.0 / - / - Ceftaroline 0.12 >32 58.5 / 0.0 / 41.5 resistant S. pneumoniae. • CoNS (62.3% methicillin-resistant) strains were very susceptible to ceftaroline (MIC50/90, 0.25/0.5 µg/mL; centers and tested for susceptibility (S) against CPT and g and skin structure infections (ABSSSI) and community-acquired Tables 1 and 2) MSSA (552) Enterobacteriaceae (1,269) Ceftriaxone 0.25 >8 56.1 / 4.9 / 39.0 comparators by the CLSI broth microdilution method. S bacterial pneumonia (CABP) and by the European Medicines Ceftaroline 0.25 0.25 100.0 / 0.0 / 0.0 Ceftaroline 0.12 >32 79.3 / 4.0 / 16.7 Ceftazidime 0.25 32 61.0 / 7.3 / 31.7 interpretations and ESBL-phenotype were determined per Ceftriaxone 4 4 100.0 / 0.0 / 0.0 Ceftriaxone ≤0.06 >8 85.2 / 0.7 / 14.1 Piperacillin/tazobactam 4 64 70.7 / 19.5 / 9.8 Agency (EMA) for similar indications. The active metabolite, • Ceftaroline was the most potent β-lactam tested against S. pneumoniae strains (MIC50/90, ≤0.015/0.12 CLSI guidelines. Erythromycin 0.25 >16 69.6 / 3.5 / 26.9 Ceftazidime 0.12 16 87.9 / 1.8 / 10.3 Meropenem ≤0.06 ≤0.06 100.0 / 0.0 / 0.0 ceftaroline, is a cephalosporin with potent bactericidal in vitro μg/mL; 100.0% susceptible). Ceftaroline (MIC50 and MIC90, 0.25 μg/mL) was eight-fold more active than Clindamycin ≤0.25 ≤0.25 95.1 / 0.2 / 4.7 Piperacillin/tazobactam 2 16 91.9 / 3.3 / 4.8 Levofloxacin ≤0.12 1 92.7 / 2.3 / 4.9 Results: 45.6% of S. aureus isolates were MRSA. CPT was activity against resistant gram-positive organisms, including ceftriaxone (MIC50 and MIC90, 2 μg/mL; data not shown) when tested against penicillin-non-susceptible Levofloxacin 0.25 2 89.5 / 0.5 / 10.0 Meropenem ≤0.06 ≤0.06 99.0 / 0.1 / 0.9 Gentamicin ≤1 ≤1 100.0 / 0.0 / 0.0 References b b very active against methicillin-S S. aureus (MSSA; MIC , (penicillin MIC, ≥4 μg/mL) pneumococci, and retained potent activity against ceftriaxone-non-susceptible Tigecycline 0.06 0.06 100.0 / - / - Levofloxacin ≤0.12 >4 80.3 / 1.2 / 18.5 Tigecycline 0.25 1 97.6 / 2.4 / 0.0 90 MRSA, and common gram-negative organisms. As part of the Linezolid 1 2 100.0 / 0.0 / 0.0 Gentamicin ≤1 8 89.7 / 0.8 / 9.5 Serratia marcescens (55) strains (MIC and MIC , 0.25 μg/mL; 100.0% susceptible; Table 1) 1. Clinical and Laboratory Standards Institute (2012). M07-A9. 0.25 µg/mL; 100.0% S) and MRSA (MIC , 1 µg/mL; 92.6% 50 90 b 90 Assessing Worldwide Antimicrobial Resistance Evaluation Vancomycin 1 1 100.0 / 0.0 / 0.0 Tigecycline 0.25 1 98.6 / 1.4 / 0.0 Ceftaroline 1 2 38.2 / 43.5 / 18.2 Methods for dilution antimicrobial susceptibility tests for S). Against MSSA, CPT was 16-, 4- and 4-fold more active Daptomycin 0.25 0.5 100.0 / - / - Escherichia coli (568) Ceftriaxone 0.25 1 90.9 / 0.0 / 9.1 (AWARE) Program, a global ceftaroline surveillance study, we • Ceftaroline was very active against viridans group (MIC50/90, ≤0.015/0.06 µg/mL) and β-hemolytic bacteria that grow aerobically; approved standard: ninth than ceftriaxone, linezolid and vancomycin, respectively. MRSA (462) Ceftaroline 0.12 >32 83.8 / 2.7 / 13.6 Ceftazidime 0.25 0.5 100.0 / 0.0 / 0.0 evaluated the activity of ceftaroline tested against contemporary streptococci (highest MIC only 0.03 µg/mL; Tables 1 and 2) edition. Wayne, PA: CLSI. Coagulase-negative staphylococci (CoNS; 62.3% MR-CoNS) Ceftaroline 1 1 92.6 / 7.4 / 0.0 Ceftriaxone ≤0.06 >8 87.9 / 0.0 / 12.1 Piperacillin/tazobactam 2 4 98.2 / 1.8 / 0.0 pathogens causing BSI in USA hospitals. Erythromycin >16 >16 11.9 / 2.4 / 85.7 Ceftazidime 0.12 4 90.3 / 1.4 / 8.3 Meropenem ≤0.06 ≤0.06 100.0 / 0.0 / 0.0 2. Clinical and Laboratory Standards Institute (2013). M100-S23. were very CPT-S (MIC90, 0.5 µg/mL). CPT (MIC50/90, • Ceftaroline exhibited good activity against non-ESBL-phenotype strains of E. coli and Klebsiella spp. Clindamycin ≤0.25 >2 65.5 / 0.0 / 34.5 Piperacillin/tazobactam 2 8 94.5 / 1.8 / 3.7 Levofloxacin ≤0.12 0.25 100.0 / 0.0 / 0.0 Performance standards for antimicrobial susceptibility testing: ≤0.015/0.12 μg/mL; 100.0% S) was 8-fold more potent than (MIC50/90, 0.12/0.5 µg/mL for both organisms), but limited activity against ESBL-phenotype strains (Table 1). Levofloxacin >4 >4 21.9 / 1.7 / 76.4 Meropenem ≤0.06 ≤0.06 99.8 / 0.2 / 0.0 Gentamicin ≤1 2 94.5 / 0.0 / 5.5 23rd informational supplement. Wayne, PA: CLSI. b b ceftriaxone (CRO; MIC50/90, ≤0.06/1 μg/mL; 94.2% S) against Among ESBL-phenotype Klebsiella spp., 24.5% of strains were meropenem-resistant (Table 2) Tigecycline 0.06 0.12 100.0 / - / - Levofloxacin ≤0.12 >4 70.0 / 0.4 / 29.6 Tigecycline 0.5 1 100.0 / 0.0 / 0.0 S.
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