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Streptococcus Pneumoniae, Viridans Group, and 50/90 Streptococci (301) 0.0 41.5 90.4 98.7 100.0 Some Nonfermenters, and Fastidious Organisms Against E

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Streptococcus Pneumoniae, Viridans Group, and 50/90 Streptococci (301) 0.0 41.5 90.4 98.7 100.0 Some Nonfermenters, and Fastidious Organisms Against E Contact Information: Michael D. Huband, BS In vitro Activity of Omadacycline and Comparators against Gram-Positive and -Negative Clinical Isolates JMI Laboratories 345 Beaver Kreek Centre, Suite A ECCMID 2018 (including resistant organism subsets) Collected in 2017 from Patients in European Medical Centres: North Liberty, IA 52317 http://paratekpharma Phone: (319) 665-3370 .com/media/1550 Fax: (319) 665-3371 Poster #P1822 SENTRY Surveillance Program Results /eccmid-2018-p1822 -sentry-2017-europe.pdf Email: [email protected] MD Huband, MA Pfaller, JM Streit, HS Sader, RK Flamm JMI Laboratories, North Liberty, Iowa, USA INTRODUCTION RESUlts (CONT.) Table 1 Antimicrobial activity of omadacycline against clinical isolates from patients in European medical centres during 2017 CONCLUSIONS (CONT.) No. of isolates at MIC (mg/L; cumulative %) Organism/organism No. of isolates at MIC (mg/L; cumulative %) • Omadacycline is an aminomethylcycline antibacterial for treating acute bacterial skin Organism/organism MIC MIC • Enterobacteriaceae including ESBL-phenotype isolates of E. coli (97.3% inhibited) • β-haemolytic streptococci (Streptococcus agalactiae, S. dysgalactiae, and MIC50 MIC90 a 50 90 group (no. of isolates) ≤0.015 0.03 0.06 0.12 0.25 0.5 1 2 4 8 16 32 > a group (no. of isolates) ≤0.015 0.03 0.06 0.12 0.25 0.5 1 2 4 8 16 32 > and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia e and K. pneumoniae (74.7% inhibited) were inhibited by ≤4 mg/L of omadacycline S. pyogenes) were very susceptible to omadacycline (MIC50/90 0.12/0.12 mg/L, Staphylococcus aureus 0 1 89 1,041 180 11 4 Enterobacteriaceae 0 56 726 886 623 292 164 123 68 21 (CABP) that recently completed Phase 3 clinical trials (oral and intravenous 0.12 0.25 1 8 highest MIC 0.5 mg/L) (1,326) 0.0 0.1 6.8 85.3 98.9 99.7 100.0 (2,959) 0.0 1.9 26.4 56.4 77.4 87.3 92.8 97.0 99.3 100.0 • Nonfermenters that included A. baumannii (72.7% inhibited) and S. maltophilia formulations) 0 51 656 397 200 53 7 6 1 0 1 69 841 116 5 1 Escherichia coli (1,371) 0.5 2 - These isolates were very susceptible (100.0%) to all agents tested except for MSSA (1,033) 0.12 0.25 0.0 3.7 51.6 80.5 95.1 99.0 99.5 99.9 100.0 (76.6% inhibited) isolates were inhibited by ≤4 mg/L of omadacycline where few other • A new drug application was submitted February 2, 2018, to the US Food and Drug tetracycline (56.1% susceptible), clindamycin (89.7% susceptible), erythromycin 0.0 0.1 6.8 88.2 99.4 99.9 100.0 0 20 200 64 6 3 Non-ESBL-phenotype 0 42 573 290 130 29 3 3 Administration for oral and intravenous omadacycline to treat ABSSSI and CABP MRSA (293) 0.12 0.25 0.5 2 treatment options exist (78.7% susceptible), and levofloxacin (98.3% susceptible; Table 2) 0.0 6.8 75.1 96.9 99.0 100.0 (1,070) 0.0 3.9 57.5 84.6 96.7 99.4 99.7 100.0 • Omadacycline demonstrates potent activity against a broad range of gram-positive Coagulase-negative 0 4 49 61 21 42 22 1 0 9 83 107 70 24 4 3 1 • Omadacycline was active against fastidious organism groups, including H. influenzae • S. pneumoniae (including penicillin-resistant strains) and viridans group streptococci 0.12 1 ESBL-phenotype (301) 1 4 (staphylococci, streptococci, and enterococci) and many Gram-negatives commonly staphylococcib (200) 0.0 2.0 26.5 57.0 67.5 88.5 99.5 100.0 0.0 3.0 30.6 66.1 89.4 97.3 98.7 99.7 100.0 were highly susceptible to omadacycline (MIC 0.06/0.12 mg/L; Tables 1-2), (MIC50/90 0.5/1 mg/L) and M. catarrhalis (MIC50/90 ≤0.12/0.25 mg/L) 50/90 0 2 25 25 3 10 7 Klebsiella pneumoniae 0 1 24 233 174 107 71 24 7 5 associated with ABSSSI, CABP, and urinary tract infections (UTI) MSCoNS (72) 0.12 0.5 2 8 whereas 21.9% of S. pneumoniae isolates were resistant to tetracycline (MIC50/90 0.0 2.8 37.5 72.2 76.4 90.3 100.0 (646) 0.0 0.2 3.9 39.9 66.9 83.4 94.4 98.1 99.2 100.0 • Omadacycline demonstrated potent in vitro activity against gram-positive and gram- • Omadacycline is highly active against bacterial clinical isolates expressing common 0.5/>4 mg/L; Table 2) and 11.2% were nonsusceptible to ceftriaxone 0 2 24 36 18 32 15 1 Non-ESBL-phenotype 0 1 14 168 94 23 19 7 MRCoNS (128) 0.25 1 1 4 negative bacterial pathogens commonly associated with ABSSSI, CABP, and UTI tetracycline-, penicillin/oxacillin-, fluoroquinolone-, and macrolide-resistance • Omadacycline was 2-fold more active against E. faecium (MIC 0.06/0.12 mg/L) 0.0 1.6 20.3 48.4 62.5 87.5 99.2 100.0 (326) 0.0 0.3 4.6 56.1 85.0 92.0 97.9 100.0 50/90 0 10 65 80 84 52 17 7 5 infections, including staphylococci, streptococci, enterococci, Enterobacteriaceae, mechanisms that include Staphylococcus aureus, coagulase-negative staphylococci β-haemolytic 0 125 147 25 4 ESBL-phenotype (320) 4 8 compared to E. faecalis (MIC 0.12/0.25 mg/L), and its activity was unchanged c 0.12 0.12 0.0 3.1 23.4 48.4 74.7 90.9 96.2 98.4 100.0 (CoNS), enterococci, streptococci (Streptococcus pneumoniae, viridans group, and 50/90 streptococci (301) 0.0 41.5 90.4 98.7 100.0 some nonfermenters, and fastidious organisms against E. faecium isolates displaying resistance to vancomycin (Table 1) Streptococcus 0 96 53 3 Enterobacter cloacae 0 2 1 48 133 11 5 3 1 β-haemolytic streptococci), and Enterobacteriaceae 0.06 0.12 f 2 2 • Omadacycline inhibited 97.3% and 74.7% of ESBL-phenotype E. coli and pyogenes (152) 0.0 63.2 98.0 100.0 species complex (204) 0.0 1.0 1.5 25.0 90.2 95.6 98.0 99.5 100.0 • These data support continued development of omadacycline in infections where Streptococcus 0 27 62 11 Acinetobacter baumannii 0 5 19 9 7 33 52 38 7 2 • The in vitro susceptibility results for omadacycline and comparator agents against K. pneumoniae isolates at ≤4 mg/L, respectively, where susceptibility to comparator 0.12 0.25 4 8 resistant gram-positive and gram-negative isolates are likely to be found, including 7,000 clinical isolates from patients in European medical centres (2017 SENTRY agalactiae (100) 0.0 27.0 89.0 100.0 (172) 0.0 2.9 14.0 19.2 23.3 42.4 72.7 94.8 98.8 100.0 agents was low (Tables 1-2) Streptococcus 0 2 32 11 4 Stenotrophomonas 0 2 12 22 5 5 1 CABP, ABSSSI, and UTI Surveillance Program) are presented 0.12 0.25 4 16 • 72.7% of A. baumannii isolates were inhibited by ≤4 mg/L of omadacycline (Table 1), dysgalactiae (49) 0.0 4.1 69.4 91.8 100.0 maltophilia (47) 0.0 4.3 29.8 76.6 87.2 97.9 100.0 Haemophilus influenzae 0 7 151 89 8 1 Streptococcus 3 70 325 102 7 0.5 1 whereas susceptibility to comparator agents ranged from 16.9% for levofloxacin to 0.06 0.12 (256) 0.0 2.7 61.7 96.5 99.6 100.0 42.4% for trimethoprim-sulfamethoxazole (Table 2) pneumoniae (507) 0.6 14.4 78.5 98.6 100.0 Penicillin-susceptible 2 58 243 57 5 β-lactamase-positive 0 1 34 22 2 0.06 0.12 0.5 1 oral (≤0.06 mg/L) (365) 0.5 16.4 83.0 98.6 100.0 (59) 0.0 1.7 59.3 96.6 100.0 ACKNOWLEDGEMENTS Materials AND METHODS • Isolates of H. influenzae (omadacycline MIC50/90 0.5/1 mg/L) and M. catarrhalis Penicillin-intermediate β-lactamase-negative 0 6 117 67 6 1 (omadacycline MIC50/90 ≤0.12/0.25 mg/L) were susceptible to omadacycline 1 11 48 24 1 0.5 1 oral (>0.06 mg/L and 0.06 0.12 (197) 0.0 3.0 62.4 96.4 99.5 100.0 This study and abstract presentation were funded by a research grant from Paratek Pharmaceuticals, Inc. • A total of 7,000 (nonduplicate) gram-positive and gram-negative bacterial clinical regardless of β-lactamase production (Table 1) 1.2 14.1 70.6 98.8 100.0 ≤1 mg/L) (85) Moraxella catarrhalis 101 36 ≤0.12 0.25 isolates were collected from patients with multiple infection types in 38 medical Penicillin-resistant oral 0 1 34 21 1 (137) 73.7 100.0 0.06 0.12 centres in 18 European countries during 2017 (>1 mg/L) (57) 0.0 1.8 61.4 98.2 100.0 a Greater than the highest dilution tested. Viridans group 1 14 33 12 5 b Organisms include: Staphylococcus capitis (15), S. epidermidis (108), S. haemolyticus (32), S. hominis (19), S. lugdunensis (16), REFERENCES • Organisms tested included 1,326 Staphylococcus aureus, 200 CoNS, 301 0.06 0.12 streptococcid (65) 1.5 23.1 73.8 92.3 100.0 S.
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