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Tigecycline and Comparator Activity Against S. Agalactiae Collected from the TEST Program (2010-2012) 2122 Palmer Dr

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Tigecycline and Comparator Activity Against S. Agalactiae Collected from the TEST Program (2010-2012) 2122 Palmer Dr IHMA, Inc. Tigecycline and Comparator Activity Against S. agalactiae Collected from the TEST Program (2010-2012) 2122 Palmer Dr. Schaumburg, IL 60173 818 B. Johnson1, S. Bouchillon1, D. Hoban1, M. Hackel1, M. Renteria1 R. Badal1, J. Johnson1, S. Hawser2, H. Leister-Tebbe3 Tel: +1.847.303.5003 1International Health Management Associates, Inc., Schaumburg, IL, USA 2IHMA Europe Sàrl, Epalinges, Switzerland Fax: +1.847.303.5601 3Pfizer Inc., Collegeville, PA, USA www.ihmainc.com Revised Abstract Introduction Results Streptococcus agalactiae, or Group B streptococcus (GBS), is the leading infectious Background: Streptococcus agalactiae or Group B cause of both early and late onset neonatal morbidity and mortality in developed Streptococcus (GBS) is a major cause of neonatal countries worldwide. Clinical trials conducted in the 1980’s demonstrated that Figure 1. Group B streptococcus infection site distribution, N=4,164 Table 1. In vitro activity of tigecycline and comparators against 4,164 isolates administration of antibiotics prior to childbirth to women colonized with GBS or at risk of of Group B streptococcus. and perinatal disease as well as a causative colonization by this pathogen could prevent invasive disease [1]. Penicillin or other beta-lactam antibiotics remain the antibiotic agents of choice for prophylaxis. pathogen of bacteremia and occasional skin and Frequently macrolides or lincosamides may be prescribed to women who are penicillin MIC (µg/ml) skin structure infections and urinary tract infections. or beta-lactam allergic. To date there have been no reported cases of isolates resistant Drug Range MIC• MIC %Susa %Int %Res to either penicillin or ampicillin, although reduced susceptibility to penicillin has been 50 90 The Tigecycline Evaluation Surveillance Trial reported. However in the United States between 5-25% of isolates have demonstrated Ampicillin ≤0.06 - 0.25 ≤0.06 0.12 100 0.0 0.0 in vitro resistance to erythromycin and between 3-17% resistance to clindamycin [2-5]. (TEST) examines the susceptibility of tigecycline Resistance to cefoxitin has been reported but still remains rare. Vancomycin is used as Ceftriaxone ≤0.03 - 0.5 0.06 0.12 100 0.0 0.0 and comparators against pathogens isolated from an alternative to ampicillin and penicillin in patients with documented beta-lactam Levofloxacin ≤0.06 - >32 0.5 1 98.3 0.4 1.3 allergies where anaphylaxis is of concern and where resistance to erythromycin or patients in countries worldwide. Methods: Clinically clindamycin is documented. Meropenem ≤0.12 - 0.5 ≤0.12 ≤0.12 100 0.0 0.0 significant GBS were obtained from the following Alternatives to standard treatment regimens have not been examined but surveillance Penicillin ≤0.06 - 0.12 ≤0.06 0.12 100 0.0 0.0 infection sites: blood, urine, respiratory, skin and studies examining the in vitro activities of carbapenems, glycylcyclines and Tigecycline ≤0.008 - 0.25 0.03 0.12 100 0.0 0.0 cephalosporins to GBS will help define the role of these agents in the future. GBS, skin structure, intra-abdominal and gastrointestinal. furthermore, can also cause infections of the bloodstream, central nervous system, Vancomycin ≤0.12 - 1 0.5 0.5 100 0.0 0.0 respiratory tract, urinary tract and skin/skin structures. MIC values were determined for 1,769, 1,189 and a Susceptibility defined by CLSI document M100-S23 (2013) where available; tigecycline interpretive criteria defined by FDA (Tygacil®, 2010)him 1,206 isolates of GBS during the years of 2010, The Tigecycline Evaluation and Surveillance Trial (TEST) examined the activity of tigecycline and comparative agents against over 278,000 pathogens collected Table 2. MIC50 values of tigecycline and comparators against 4,164 isolates of Table 3. MICI are90 values of tigecycline and comparators against 4,164 2011 and 2012, respectively. Isolates were collected worldwide since 2004. This report documents the in vitro activity of tigecycline and Group B streptococcus stratified by year. isolates of Group B streptococcus stratified by year. from a cumulative total of 781 sites in 56 countries comparators against 4,164 isolates of GBS isolated worldwide during 2010-2012. using supplied broth microdilution panels. Results MIC50 Values (µg/ml) by Year MIC90 Values (µg/ml) by Year were interpreted according to FDA/CLSI guidelines. Materials & Methods 2010 2011 2012 2010 2011 2012 Results: The MIC50 and MIC90 (mcg/mL) for 4,164 • All isolates were derived from a variety of clinical specimens/infectious process Drug n=1,769 n=1,189 n=1,206 Drug n=1,769 n=1,189 n=1,206 GBS versus comparative antimicrobial agents is including blood, central nervous system, respiratory, urine, and skin/skin structure, worldwide. Only one isolate per patient was accepted into the study. Ampicillin ≤0.06 0.12 ≤0.06 Ampicillin 0.12 0.12 0.12 shown in the following table: Clinical isolates were collected and tested between 2010 and 2012 from 781 cumulative study centers in 56 countries. Isolates were identified to the species Ceftriaxone 0.06 0.06 0.06 Ceftriaxone 0.12 0.12 0.12 level and tested at each site by the participating laboratory. Levofloxacin 0.5 1 0.5 Levofloxacin 1 1 1 • Minimum inhibitory concentrations were determined by the CLSI recommended broth microdilution testing method [6]. Panels were manufactured by MicroScan S. agalactiae - MIC50/90 mcg/mL Meropenem ≤0.12 ≤0.12 ≤0.12 Meropenem ≤0.12 ≤0.12 ≤0.12 (Siemens Medical Solutions Diagnostics, West Sacramento, CA, USA) or Trek 2010 2011 2012 (TREK Diagnostic Systems, Cleveland, OH, USA). Penicillin ≤0.06 ≤0.06 ≤0.06 Penicillin 0.059 0.12 0.12 Antibiotic n=1,769 n=1,189 n=1,206 • QC of broth microdilution panels followed manufacturers’ and CLSI guidelines using Streptococcus pneumoniae ATCC 49619. Tigecycline 0.06 0.03 0.03 Tigecycline 0.12 0.25 0.12 Ampicillin <0.06/0.12 0.12/0.12 <0.06/0.12 • Quality controls were performed by each testing site on each day of testing and Vancomycin 0.5 0.5 0.5 Vancomycin 0.5 1 0.5 Ceftriaxone 0.06/0.12 0.06/0.12 0.06/0.12 results were included in the analysis only when corresponding QC isolates tested were within the acceptable range according to CLSI (2011) guidelines [7]. Levofloxacin 0.5/1 1/1 0.5/1 Table 4. Percents susceptible (%) of tigecycline and comparators against 4,164 Conclusions Meropenem <0.12/<0.12 <0.12/<0.12 <0.12/<0.12 References isolates of Group B streptococcus stratified by year. • No resistance or increase in either MIC or MIC was detected in GBS Penicillin <0.06/<0.06 <0.06/0.12 <0.06/0.12 1. MMWR November 19, 2010. P.1-32. 50 90 2. Andrews JJ, Diekma DJ, Hunter SK, et al. 2000. Group B streptococci causing neonatal % Susceptible by Year against ampicillin, ceftriaxone, meropenem, penicillin, tigecycline, Tigecycline 0.06/0.12 0.03/0.25 0.03/0.12 bloodstream infection: antimicrobial susceptibility and serotyping results from the SENTRY centers in the Western Hemisphere. Am J Obstet Gynecol; 183:859-862. 2010 2011 2012 vancomycin over the 3 year study period between 2010 and 2012. Vancomycin 0.5/0.5 0.5/1 0.5/0.5 3. Fernandez M, Hickman ME, Baker CJ. 1998. Antimicrobial susceptibilities of group B streptococci isolated between 1992 and 1996 from patients with bacteremia and meningitis. AAC; 42: 1517- Drug n=1,769 n=1,189 n=1,206 1519. • Only levofloxacin demonstrated any decrease in susceptibility against GBS 4. Lin FYC, Azimi PH, Weisman LE et al. 2000. Antibiotic susceptibility profiles for group B streptococci isolated from neonates, 1995-1998. CID; 31: 76-79. Ampicillin 100 100 100 with 1.7% of the isolates non-susceptible. The annual fluctuations seen in 5. Morales WJ, Dickey SS, Bornick P, Lim DV. 1999. Change in antibiotic resistance of group B Conclusions: The MIC values did not increase streptococcus: impact on intrapartum management. Am J Obstet Gynecol; 181:310-314. Ceftriaxone 100 100 100 the percents susceptible for levofloxacin were not statistically significant 50/90 6. CLSI, 2012, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow for any studied antimicrobial over the three year Aerobically; Approved Standards, Ninth edition. CLSI document M07-A9. CLSI, Wayne, Levofloxacin 98.9 96.9 98.8* over the study period (p=0.421). Pennsylvania 19807 USA. study period. Global GBS isolated from a variety of 7. CLSI. 2013. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third Meropenem 100 100 100 Informational Supplement. CLSI Document M100-S23. CLSI, Wayne, Pennsylvania 19087 USA. • Global GBS isolated from a variety of clinical specimens continue to clinical specimens continue to demonstrate low 8. Tygacil®, 2012. FDA product information. Pfizer Inc., Collierville, PA, USA Penicillin 100 100 100 demonstrate low MIC50 and MIC90 values for all of the study antimicrobials. MIC50 and MIC90 for all of the antimicrobials. Tigecycline 100 100 100 This surveillance of over 4,164 GBS between 2010-2012 documents the Levofloxacin and vancomycin demonstrated the Acknowledgments Vancomycin 100 100 100 continued excellent in vitro activity of tigecycline and comparator highest MIC at 0.5/1. We gratefully acknowledge the contributions of the investigators, laboratory personnel, and all members 50/90 of the Tigecycline Evaluation Study Trials program group. This study was sponsored by a grant from * P-value = 0.421 (Cochran-Armitage Trend Test) antimicrobials. Pfizer, Inc..
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