scholarly journals 214. Prospective Evaluation of the GenMark Dx ePlex® Blood Culture Identification Gram Negative Panel

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S215-S215
Author(s):  
Jeremy Meeder ◽  
Derek Moates ◽  
Hannah Pierce ◽  
Jamie Hutchinson ◽  
Pia Cumagun ◽  
...  
Keyword(s):  
Blood Culture ◽  
Antimicrobial Therapy ◽  
Standard Of Care ◽  
Quality Data ◽  
Resistant Bacteria ◽  
M Gene ◽  
Research Support ◽  
Gram Negative ◽  
Material Support ◽  
Percent Agreement

Abstract Background The ePlex BCID Gram-Negative (GN) panel utilizes electrowetting technology to detect the most common causes of GN bacteremia (21 targets) and 6 antimicrobial resistance genes from positive blood culture bottles. Rapid detection of extended spectrum β-lactamases (ESBL; CTX-M), carbapenemases (KPC, NDM, IMP, VIM, OXA 23/48), and highly resistant bacteria such as Stenotrophomonas maltophilia enables early optimization of antimicrobial therapy. Methods In this prospective study, we evaluated the performance of the BCID-GN panel compared to traditional standard of care culture and susceptibility testing with organism identification using the BioMerieux Vitek MS Matrix Assisted Laser Desorption Ionization (MALDI) Time of Flight mass spectrometry. Samples submitted for standard of care testing in Biomerieux BacT/Alert resin FA/FN blood culture bottles on the BacT/Alert VIRTUO automated blood culture system with GN bacteria on direct exam (n=108) were included. Results All but two GN bacteria identified by MALDI were represented on the BCID-GN Panel (106/108, 98.1%) and most tests (107/108, 99.1%) yielded valid results. Discordant analyses revealed a positive percent agreement (PPA) of 102/105 (97.2%) with 3 false negatives (2 pan-susceptible Enterobacterales, 1 ESBL E.coli) and a negative percent agreement (NPA) of 105/105 (100%). Consistent with alternative resistance mechanisms, only 8/12 (66.7%) of Enterobacterales with resistance to 3rd generation cephalosporins harbored the CTX-M gene. In contrast, 8/8 (100%) of isolates from samples harboring the CTX-M gene were resistant to 3rd generation cephalosporins. Conclusion Detection of 1 S. maltophilia, 1 Acinetobacter baumannii expressing OXA 23/48, and 8 Enterobacterales expressing CTX-M represent opportunities for early optimization of antimicrobial therapy in 10/108 (9.3%) of samples. The BCID-GN Panel provides rapid accurate detection of resistant gram negative bacteria enabling high quality data driven optimization of antimicrobial therapy. Disclosures Todd P. McCarty, MD, Cidara (Grant/Research Support)GenMark (Grant/Research Support, Other Financial or Material Support, Honoraria for Research Presentation)T2 Biosystems (Consultant) Sixto M. Leal, Jr., MD, PhD, Abnova (Grant/Research Support)AltImmune (Grant/Research Support)Amplyx Pharmaceuticals (Grant/Research Support)Astellas Pharmaceuticals (Grant/Research Support)CNINE Dx (Grant/Research Support)GenMark Diagnostics (Grant/Research Support, Other Financial or Material Support, Honoraria- Research Presentation)IHMA (Grant/Research Support)IMMY Dx (Grant/Research Support)JMI/Sentry (Grant/Research Support)mFluiDx Dx (Grant/Research Support)SpeeDx Dx (Grant/Research Support)Tetraphase Pharmaceuticals (Grant/Research Support)

scholarly journals 1022. Evaluating the Impact of GenMark Dx ePlex® Blood Culture Identification (BCID) on Gram-negative Bloodstream Infections

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S602-S603
Author(s):  
Pia Cumagun ◽  
Jeremy Meeder ◽  
Derek Moates ◽  
Hannah Pierce ◽  
Todd P McCarty ◽  
...  
Keyword(s):  
Blood Culture ◽  
Antimicrobial Therapy ◽  
Resistant Bacteria ◽  
Research Support ◽  
Gram Positive ◽  
Negative Spectrum ◽  
Gram Negative ◽  
Material Support ◽  
Organism Identification ◽  
The Impact

Abstract Background The GenMark Dx ePlex BCID Gram-Negative (GN) panel utilizes electrowetting technology to detect the most common causes of GN bacteremia (21 targets) and 6 antimicrobial resistance (AMR) genes from positive blood culture (BC) bottles. Rapid detection of extended spectrum β-lactamases (ESBL: CTX-M & carbapenemases: KPC, NDM, IMP, VIM, OXA 23/48), and highly resistant bacteria such as S. maltophilia should enable early optimization of antimicrobial therapy. Methods In this prospective study, aliquots of positive BC bottles with GN bacteria detected on Gram stain (GS) (n=108) received standard of care (SOC) culture and antimicrobial susceptibility testing (AST). Additionally, samples were evaluated with the BCID-GN panel but only SOC results were reported in the EMR and available to inform clinical decisions. Chart reviews were performed to evaluate the impact of the BCID-GN panel on the time to organism identification, AST results, and optimization of antimicrobial therapy. Results A total of 108 patients are included in the analysis (Table 1). Escherichia coli was the most common bacteria identified followed by Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterobacter species (Table 2). There were 11 (10.2%) polymicrobial bacteremias. Repeat BCs were obtained in 68 (63%) patients of which 13 (19%) were persistently positive. Eight (7%) patients had evidence of additional gram-positive (GP) pathogens. Organism identification occurred 26.7 hours faster than culture. In conjunction with GS, negative pan-GP marker data could have helped providers make the decision to remove GP antibiotic coverage in 63 (58%) patients. Narrowing from empiric meropenem could have occurred in 5 patients. Of 10 individuals infected with resistant isolates (1 S. maltophilia, 1 OXA 23/48, and 8 CTX-M) empiric therapy was ineffective in 4 (40%) cases. Optimization of antimicrobial therapy for 9 (8.3%) patients could have occurred an average of 52.4 hours earlier than standard methods. Table 1. Patient demographics and co-morbidities. Table 2. Gram-negative bacteria frequency. Conclusion The BCID-GN panel enabled earlier time to optimal treatment of highly resistant bacteria as well as multiple opportunities for narrowing gram negative spectrum and a higher degree of certainty in cessation of broad-spectrum gram-positive antibiotics Disclosures Todd P. McCarty, MD, Cidara (Grant/Research Support)GenMark (Grant/Research Support, Other Financial or Material Support, Honoraria for Research Presentation)T2 Biosystems (Consultant) Sixto M. Leal, Jr., MD, PhD, Abnova (Grant/Research Support)AltImmune (Grant/Research Support)Amplyx Pharmaceuticals (Grant/Research Support)Astellas Pharmaceuticals (Grant/Research Support)CNINE Dx (Grant/Research Support)GenMark Diagnostics (Grant/Research Support, Other Financial or Material Support, Honoraria- Research Presentation)IHMA (Grant/Research Support)IMMY Dx (Grant/Research Support)JMI/Sentry (Grant/Research Support)mFluiDx Dx (Grant/Research Support)SpeeDx Dx (Grant/Research Support)Tetraphase Pharmaceuticals (Grant/Research Support)

scholarly journals 200. Prospective Evaluation of the GenMark Dx ePlex® Blood Culture Identification Gram Positive Panel

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S208-S208
Author(s):  
Jeremy Meeder ◽  
Derek Moates ◽  
Hannah Pierce ◽  
Jamie Hutchinson ◽  
Cameron White ◽  
...  
Keyword(s):  
Blood Culture ◽  
Resistance Genes ◽  
Antimicrobial Therapy ◽  
False Negative ◽  
Meca Gene ◽  
Standard Of Care ◽  
Gene Detection ◽  
Research Support ◽  
Coagulase Negative Staphylococci ◽  
Material Support

Abstract Background The ePlex BCID Gram-Positive (GP) panel utilizes electrowetting technology to detect the most common causes of GP bacteremia (20 targets) and 4 antimicrobial resistance genes in positive blood culture bottles. Rapid detection of intrinsic vancomycin resistance and acquired resistance genes (mecA, mecC, vanA, vanB) enables early optimization of antimicrobial therapy whereas early detection of common contaminants decreases unnecessary antibiotic utilization and hospitalizations. Methods In this prospective study, we evaluated the performance of the BCID-GP panel compared to traditional standard of care culture and susceptibility testing with organism identification using the BioMerieux Vitek MS Matrix Assisted Laser Desorption Ionization (MALDI) Time of Flight mass spectrometry. Samples submitted for standard of care testing in Biomerieux BacT/Alert resin FA/FN blood culture bottles on the BacT/Alert VIRTUO automated blood culture system with GP bacteria on direct exam (n=100) were included. Results All GP bacteria were represented on the BCID-GP panel, most tests 97/100 (97%) yielded valid results, 53 common skin contaminants (50 coagulase negative staphylococci (CNS), 2 Bacillus, 1 Corynebacterium) were identified, and 7/7 coinfections with Gram negative (GN) bacteria were detected by the Pan GN target and identified by the BCID-GN panel. Discordant analyses revealed a positive percent agreement (PPA) of 96/97 (99%) with 1 false negative CNS and a negative percent agreement (NPA) of 92/97 (94.8%) with 5 false positives for either S. epidermidis or Corynebacterium. Detection of vanA yielded a PPA of 4/4 and NPA of 9/9. mecA gene detection exhibited a PPA of 14/14 and NPA of 14/14 for S. aureus and a PPA of 31/32 (97%) and NPA of 16/16 for coagulase negative staphylococci with 1 false negative methicillin resistant S. epidermidis. Conclusion Detection of acquired vancomycin resistance (n=4) and absence of mecA gene detection in Staphylococcus species (n=30) represent opportunities for early optimization of antimicrobial therapy in 34/100 (34%) of samples. The BCID-GP panel provides rapid accurate detection of resistant isolates and common contaminants enabling high quality data driven optimization of antimicrobial therapy. Disclosures Todd P. McCarty, MD, Cidara (Grant/Research Support)GenMark (Grant/Research Support, Other Financial or Material Support, Honoraria for Research Presentation)T2 Biosystems (Consultant) Sixto M. Leal, Jr., MD, PhD, Abnova (Grant/Research Support)AltImmune (Grant/Research Support)Amplyx Pharmaceuticals (Grant/Research Support)Astellas Pharmaceuticals (Grant/Research Support)CNINE Dx (Grant/Research Support)GenMark Diagnostics (Grant/Research Support, Other Financial or Material Support, Honoraria- Research Presentation)IHMA (Grant/Research Support)IMMY Dx (Grant/Research Support)JMI/Sentry (Grant/Research Support)mFluiDx Dx (Grant/Research Support)SpeeDx Dx (Grant/Research Support)Tetraphase Pharmaceuticals (Grant/Research Support)

scholarly journals 640. Randomized Clinical Trial Evaluating Clinical Impact of RAPid IDentification and Antimicrobial Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S296-S297
Author(s):  
Ritu Banerjee ◽  
Ritu Banerjee ◽  
Lauren Komarow ◽  
Abinash Virk ◽  
Nipunie S Rajapakse ◽  
...  
Keyword(s):  
Blood Culture ◽  
Susceptibility Testing ◽  
Clinical Impact ◽  
Gram Stain ◽  
Research Support ◽  
Gram Negative ◽  
Material Support ◽  
Soc Testing ◽  
Gram Negative Bacteremia ◽  
Research Grant

Abstract Background Rapid blood culture diagnostics increase cost and have unclear benefit for patients with Gram-negative bacilli (GNB) bloodstream infections (BSIs). We conducted a multicenter, prospective randomized controlled trial (RAPIDS-GN), comparing outcomes of patients with GNB BSI who had blood culture testing with standard of care (SOC) culture and antibiotic susceptibility testing (AST) vs. rapid organism identification (ID) and phenotypic AST using the Accelerate Pheno System (AXDX). Methods Subjects with blood culture Gram stain showing GNB were randomized to receive SOC testing with antimicrobial stewardship review (AS) or AXDX plus SOC testing with AS, at two academic medical centers between October 2017 and October 2018. SOC testing included rapid MALDI-TOF mass spectrometry ID and agar dilution or broth microdilution AST. In a modified intention to treat analysis, subjects were excluded if: Gram stain was erroneous, culture was positive during off-hours, blood culture in the prior week had GNB, they were deceased/on comfort care, or admitted to a nonparticipating hospital. The primary outcome was time to first antibiotic modification within 72 hours after randomization. Subjects without antibiotic modifications were assigned a time of 72 hours. No censoring was observed. T-tests and Wilcoxon rank-sum tests were used for statistical analyses. Results Of 500 randomized subjects, 448 were included (226 SOC, 222 AXDX). Groups did not differ in baseline characteristics (Table 1). Median (IQR) hours to first antibiotic modification was faster in the AXDX vs. SOC group [8.6 (2.6, 27.6) vs. 14.9 (3.3, 41.1)], P = 0.02 (Figure 1). Median (IQR) hours to first Gram-negative antibiotic modification (including escalation and de-escalation) was faster in the AXDX than SOC group [17.4 (4.9, 72) vs. 42.1 (10.1, 72)], P < 0.001 (Figure 2). Groups did not differ in clinical outcomes (Table 2). Mean (S.D.) time to results was faster for AXDX than SOC for organism ID [2.7 (1.2) h vs. 15.6 (20.3) h, P < 0.001] and AST [13 (55.7) h vs. 54.6 (45.5) h, P < 0.001]. Conclusion In the largest trial to evaluate the clinical impact of a blood culture diagnostic for GNB BSI, we found that rapid organism ID and phenotypic AST led to faster changes in antibiotic therapy for Gram-negative bacteremia. Disclosures Ritu Banerjee, MD, PhD, Accelerate Diagnostics: Grant/Research Support; BioFire: Research Grant; Biomerieux: Research Grant; Roche: Research Grant Robin Patel, MD, ASM and IDSA: Other Financial or Material Support, Travel reimbursement, editor’s stipends; CD Diagnostics, Merck, Hutchison Biofilm Medical Solutions, Accelerate Diagnostics, ContraFect, TenNor Therapeutics Limited, Shionogi: Grant/Research Support; Curetis, Specific Technologies, NextGen Diagnostics, PathoQuest, Qvella: Consultant; NBME, Up-to-Date, the Infectious Diseases Board Review Course: Honorarium recipient, Other Financial or Material Support; Patent on Bordetella pertussis/parapertussis PCR issued, a patent on a device/method for sonication with royalties paid by Samsung to Mayo Clinic, and a patent on an anti-biofilm substance issued: Other Financial or Material Support, Patents.

scholarly journals Comparison of Pharmacist-Directed Management of Multiplex PCR Blood Culture Results with Conventional Microbiology Methods on Effective and Optimal Therapy within a Community Hospital

2018 ◽  
Vol 63 (1) ◽  
Author(s):  
Allison M. Porter ◽  
Christopher M. Bland ◽  
Henry N. Young ◽  
David R. Allen ◽  
Sabrina R. Croft ◽  
...  
Keyword(s):  
Blood Culture ◽  
Multiplex Pcr ◽  
Positive Blood Culture ◽  
Antimicrobial Therapy ◽  
Community Hospital ◽  
Intervention Group ◽  
Standard Of Care ◽  
Pharmacist Intervention ◽  
Coagulase Negative Staphylococcus ◽  
Optimal Therapy

ABSTRACT Multiplex PCR combined with a pharmacist-driven reporting protocol was compared to the standard of care within a community hospital to evaluate initial changes after notification of a positive blood culture. The intervention group demonstrated decreased times to changes in antimicrobial therapy (P = 0.0081), increased changes to optimal antimicrobial therapy (P = 0.013), and decreased vancomycin use for coagulase-negative staphylococcus contaminants (P < 0.01) with multiplex PCR implementation and pharmacist intervention.

scholarly journals Antimicrobial Resistance Patterns of Bacterial Isolates from Blood Culture among HIV/AIDS Patients at Felege Hiwot Referral Hospital, Northwest Ethiopia

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Mohabaw Jemal ◽  
Teshiwal Deress ◽  
Teshome Belachew ◽  
Yesuf Adem
Keyword(s):  
Antimicrobial Resistance ◽  
Blood Culture ◽  
Agar Plate ◽  
Blood Cultures ◽  
Resistant Bacteria ◽  
Bacterial Isolates ◽  
Aids Patients ◽  
Gram Positive ◽  
Gram Negative ◽  
Hiv Aids

Background. The emergence and spread of antimicrobial resistance in bacteria is recognized as a global public health problem. Bloodstream infection with antimicrobial-resistant bacteria in HIV/AIDS patients makes the problem more challenging. So, regular and periodic diagnosis and use of the appropriate antimicrobial susceptibility pattern determination is the only option for decreasing the prevalence and development of drug-resistant bacteria. Methods. An institution-based cross-sectional study was conducted among 384 HIV/AIDS patients. Sociodemographic data of patients were recorded using structured questionnaires. Blood cultures were collected with BACTEC aerobic blood culture bottles. A pair of samples was collected from each patient aseptically and incubated at 37°. If samples are positive for bacterial agents, they were subcultured to solid media such as blood agar plate, chocolate agar plate, and MacConkey agar plates. Identification was performed using colony characteristics and standard biochemical techniques. The antimicrobial susceptibility test was determined by the Kirby–Bauer disc diffusion method. Data entry and analysis were performed while using SPSS version 20. Descriptive statistics were performed to calculate frequencies. Results. Altogether, 384 patients were included, and 123 blood cultures were positive, so that the yield was thus 32%. About 46 (37.4%) of Gram-negative and 77 (62.6%) of Gram-positive bacterial species were identified. Among Gram-negative bacterial isolates, K. pneumoniae was the leading pathogen, 19 (41.3%), whereas S. aureus, 38 (49.4%), was predominant among Gram-positive isolates. In his study, the majority of Gram-positive isolates showed high level of resistance to penicillin, 72 (95.5%), tetracycline, 55 (71.4%), and cotrimoxazole, 45 (58.4%). About 28 (73.6%) of S. aureus isolates were also methicillin-resistant. Gram-negative bacterial isolates also showed a high resistance to ampicillin (91.3%), tetracycline (91.3%), and gentamicin (47.8%). Overall, about 78% of multidrug resistance was observed. Conclusion. Several pathogens were resistant to greater than five antimicrobial agents, so that proper management of patients with bacteremia is needed, and a careful selection of effective antibiotics should be practiced.

scholarly journals 297. Infectious Complications Associated with Tocilizumab Use in Patients Infected with SARS-CoV-2 at a Mid-Atlantic Hospital Consortium

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S256-S256
Author(s):  
Kristen R Kent ◽  
Nellie Darling ◽  
Xue Geng ◽  
Gavin Clark ◽  
Marybeth Kazanas ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Post Treatment ◽  
Risk Of Infection ◽  
Research Support ◽  
Candida Spp ◽  
Gram Positive ◽  
Gram Negative ◽  
Material Support ◽  
Increased Risk ◽  
Significant Difference

Abstract Background The IL-6 inhibitor Tocilizumab (TOCI) has been associated with infections in 5-8% of patients with Rheumatoid Arthritis. TOCI has now been recommended as a treatment option for select patients with COVID-19; however, the risk of infection in this patient population is yet to be determined. Methods We performed a retrospective chart review of patients diagnosed with COVID-19 and admitted to MedStar hospitals within the D.C./Baltimore corridor from 03/01/2020 to 12/31/2020. We identified patients who had positive culture data within 30 days of administration of TOCI-based regimens and analyzed clinical characteristics and outcomes. Univariate analyses (Wilcoxon, T-test, Chi-Square, Fisher’s Exact) were used to compare these outcome variables between patients who had post-treatment infections and those who did not. Results A total of 220 patients received TOCI-based regimens; 16% (N=36) of patients developed positive cultures within 30 days of treatment. Of the 99 cultures, 50% were gram positive (N=49), 38% were gram negative (N=38), 10% were Candida spp. (N=10), and 2% were anaerobic organisms (N=2). Only 9% (8/87) of the gram positive and gram negative organisms were MDROs. Bloodstream infections were the most common and accounted for 58.4% of all infections. Length of stay (LOS) was approximately twice as long in those with post-treatment infections (26 days) compared to those without infections (14 days, p&lt; 0.001). Although the mortality rate was higher in patients with infections after TOCI-based treatment compared to patients with no post-treatment infection (47% vs 31% respectively), this did not reach statistical significance (p=0.09). Moreover, there was no significant difference in the infection rate of patients treated with TOCI alone compared to TOCI and Dexamethasone (16.6% vs. 13.3%, p=0.99). No cases of invasive Aspergillosis were observed. Conclusion Tocilizumab treatment in patients with COVID-19 may predispose patients to an increased risk of infection which is associated with a prolonged LOS and possibly higher mortality. We observed a two-fold increase in infections in COVID-19 patients compared to other patient groups receiving this treatment. Disclosures Princy N. Kumar, MD, AMGEN (Other Financial or Material Support, Honoraria)Eli Lilly (Grant/Research Support)Gilead (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)GSK (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)Merck & Co., Inc. (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)

scholarly journals 639. Time to Recurrence of Clostridioides difficile Infection (rCDI) is Rapid Following Completion of Standard of Care Antibiotics: Results from ECOSPOR-III, a Phase 3 Double-Blind, Placebo-Controlled Randomized Trial of SER-109, an Investigational Microbiome Therapeutic

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S422-S422
Author(s):  
Thomas J Louie ◽  
Matthew Sims ◽  
Richard Nathan ◽  
Steven O'Marro ◽  
Princy N Kumar ◽  
...  
Keyword(s):  
Panel Member ◽  
Standard Of Care ◽  
Oral Microbiome ◽  
Research Support ◽  
Independent Contractor ◽  
Review Panel ◽  
Material Support ◽  
Time To Recurrence ◽  
Study Population

Abstract Background The natural history of CDI recurrence after antibiotics may be helpful to understand the window of opportunity for microbiome repair. ECOSPOR III evaluated the efficacy of SER-109, an investigational microbiome therapeutic, compared to placebo with rates of rCDI as the primary endpoint. SER-109 was superior to placebo in reducing the rate of rCDI following standard-of-care antibiotics at 8 weeks (12.4% vs 39.8%, respectively; P &lt; 0.001). Herein, we describe results from the secondary endpoint, time to recurrence, in this well-characterized study population. Methods A total of 182 C. difficile toxin+ adults with ≥ 3 CDI episodes and symptom resolution on CDI antibiotics were randomly assigned to SER-109 (4 capsules orally x 3 days) or placebo. Recurrence for this analysis was defined as ≥ 3 unformed stools/day for ≥ 48 hours, ± C. difficile stool toxin test, and an investigator decision to treat. Time to CDI recurrence was analyzed using observed data and Kaplan-Meier methods. Data were not imputed for subjects lost to follow-up or discontinued from study. Subjects who did not have a CDI recurrence were censored on the date of study completion, study discontinuation or death. Results Through 24 weeks, 11/89 (12.4%) SER-109 and 36/93 (38.7%) placebo subjects had rCDI (P &lt; 0.001). Of all recurrence events in the study population, 16/47 (34.0%) were observed within 1 week; 30/47 (63.8%) within 2 weeks; and 34/47 (72.3%) within 4 weeks after randomization, highlighting the rapid onset of recurrence. On the other hand, 12/47 (25.5%) recurrences occurred between 4 and 12 weeks, highlighting late onset of recurrence in a subset of patients (Table). Significantly lower rates of recurrence in patients on SER-109 compared to placebo was maintained throughout the 24-week follow-up (Figure). Time of rCDI K-M Plot Conclusion SER-109, an investigational oral microbiome therapeutic, maintained significant efficacy in reducing rCDI vs placebo through 24 weeks. About two-thirds of all recurrences occurred within 14 days of antibiotic completion highlighting the need for rapid repair of the disrupted microbiome. However, the significant number of late recurrences in the placebo arm also highlights that rCDI trials limited to 4 weeks of follow-up after treatment completion may underestimate recurrences. Disclosures Thomas J. Louie, MD, Artugen (Advisor or Review Panel member)Crestone (Consultant, Grant/Research Support)Da Volterra (Advisor or Review Panel member)Finch Therapeutics (Grant/Research Support, Advisor or Review Panel member)MGB Biopharma (Grant/Research Support, Advisor or Review Panel member)Rebiotix (Consultant, Grant/Research Support)Seres Therapeutics (Consultant, Grant/Research Support)Summit PLC (Grant/Research Support)Vedanta (Grant/Research Support, Advisor or Review Panel member) Matthew Sims, MD, PhD, Astra Zeneca (Independent Contractor)Diasorin Molecular (Independent Contractor)Epigenomics Inc (Independent Contractor)Finch (Independent Contractor)Genentech (Independent Contractor)Janssen Pharmaceuticals NV (Independent Contractor)Kinevant Sciences gmBH (Independent Contractor)Leonard-Meron Biosciences (Independent Contractor)Merck and Co (Independent Contractor)OpGen (Independent Contractor)Prenosis (Independent Contractor)Regeneron Pharmaceuticals Inc (Independent Contractor)Seres Therapeutics Inc (Independent Contractor)Shire (Independent Contractor)Summit Therapeutics (Independent Contractor) Richard Nathan, DO, none (Other Financial or Material Support, I am PI on several clinical trials. If you need that information, I would be happy to supply it.) Princy N. Kumar, MD, AMGEN (Other Financial or Material Support, Honoraria)Eli Lilly (Grant/Research Support)Gilead (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)GSK (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)Merck & Co., Inc. (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria) Elaine E. Wang, MD, Seres Therapeutics (Employee) Elaine E. Wang, MD, Seres Therapeutics (Employee, Shareholder) Robert Stevens, PharmD, Seres Therapeutics (Employee, Shareholder) Kelly Brady, MS, Seres Therapeutics (Employee, Shareholder) Barbara McGovern, MD, Seres Therapeutics (Employee, Shareholder) Lisa von Moltke, MD, Seres Therapeutics (Employee, Shareholder)

Letter To The Editor

PEDIATRICS ◽  
1970 ◽  
Vol 46 (2) ◽  
pp. 315-316
Author(s):  
Heinz F. Eichenwald
Keyword(s):  
United States ◽  
Antimicrobial Therapy ◽  
The United States ◽  
Resistant Bacteria ◽  
Gram Negative ◽  
E Coli ◽  
Continuous Review ◽  
Letter To The Editor ◽  
Emergence Of Resistance

Dr. Franciosi raises a point which deserves emphasis: antimicrobial therapy is not a static process; the widespread use of an antibiotic will often result in emergence of resistant bacteria necessitating continuous review of recommendations for therapy. The emergence of resistance of gram-negative enterobacteria to kanamycin, including not only E. coli but also klebsiella-aerobacter, has been reported to us from a number of areas in the United States and is recorded in scattered reports in the literature.

scholarly journals Identification of Gram-Negative Bacteria and Genetic Resistance Determinants from Positive Blood Culture Broths by Use of the Verigene Gram-Negative Blood Culture Multiplex Microarray-Based Molecular Assay

2015 ◽  
Vol 53 (8) ◽  
pp. 2460-2472 ◽  
Author(s):  
Nathan A. Ledeboer ◽  
Bert K. Lopansri ◽  
Neelam Dhiman ◽  
Robert Cavagnolo ◽  
Karen C. Carroll ◽  
...  
Keyword(s):  
Blood Culture ◽  
Positive Blood Culture ◽  
Klebsiella Oxytoca ◽  
Genetic Resistance ◽  
Reference Method ◽  
Negative Blood Culture ◽  
Gram Negative ◽  
Content Type ◽  
Resistance Determinants ◽  
Percent Agreement

Bloodstream infection is a serious condition associated with significant morbidity and mortality. The outcome of these infections can be positively affected by the early implementation of effective antibiotic therapy based on the identification of the infecting organism and genetic markers associated with antibiotic resistance. In this study, we evaluated the microarray-based Verigene Gram-negative blood culture (BC-GN) assay in the identification of 8 genus or species targets and 6 genetic resistance determinants in positive blood culture broths. A total of 1,847 blood cultures containing Gram-negative organisms were tested using the BC-GN assay. This comprised 729 prospective fresh, 781 prospective or retrospective frozen, and 337 simulated cultures representing 7 types of aerobic culture media. The results were compared to those with standard bacterial culture and biochemical identification with nucleic acid sequence confirmation of the resistance determinants. Among monomicrobial cultures, the positive percent agreement (PPA) of the BC-GN assay with the reference method was as follows; Escherichia coli , 100%; Klebsiella pneumoniae , 92.9%; Klebsiella oxytoca , 95.5%; Enterobacter spp., 99.3%; Pseudomonas aeruginosa , 98.9%; Proteus spp., 100%; Acinetobacter spp., 98.4%; and Citrobacter spp., 100%. All organism identification targets demonstrated >99.5% negative percent agreement (NPA) with the reference method. Of note, 25/26 cultures containing K. pneumoniae that were reported as not detected by the BC-GN assay were subsequently identified as Klebsiella variicola . The PPA for identification of resistance determinants was as follows; bla CTX-M , 98.9%; bla KPC , 100%; bla NDM , 96.2%; bla OXA , 94.3%; bla VIM , 100%; and bla IMP , 100%. All resistance determinant targets demonstrated >99.9% NPA. Among polymicrobial specimens, the BC-GN assay correctly identified at least one organism in 95.4% of the broths and correctly identified all organisms present in 54.5% of the broths. The sample-to-result processing and automated reading of the detection microarray results enables results within 2 h of culture positivity.

scholarly journals 1368. The Clinical Impact of BioFire BCID2 Compared to BCID in a U.S. Pediatric Hospital

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S694-S694
Author(s):  
Kelly E Graff ◽  
Claire Palmer ◽  
Toraj Anarestani ◽  
Darcy Velasquez ◽  
Stacey Hamilton ◽  
...  
Keyword(s):  
Blood Culture ◽  
Enterococcus Faecalis ◽  
Resistance Genes ◽  
Antimicrobial Therapy ◽  
Enteric Bacteria ◽  
Species Level ◽  
Effective Therapy ◽  
Research Support ◽  
Standard Culture ◽  
Culture Identification

Abstract Background Multiplex PCR panels, particularly BioFire FilmArray Blood Culture Identification (BCID), have been shown to decrease time to pathogen identification and time to effective and optimal antimicrobial therapy. BioFire Blood Culture Identification 2 (BCID2) has an additional 17 targets and resistance genes compared to BCID. There is limited data on the impact of these expanded targets in pediatric populations. Methods We performed a head-to-head comparison between BioFire BCID2 with BCID when compared to standard culture. From January 2020- May 2020, we ran BCID2 simultaneously as a research use only prototype with the current standard of care on all blood culture specimens at Children’s Hospital Colorado. Percent agreement was calculated with BCID2 compared to standard culture and BCID compared to standard culture. Time to positivity, time to optimal therapy, and time to effective therapy were also calculated. Results We performed an interim analysis halfway through the study with 86 unique positive blood cultures. We found equal organism detection rates between BCID and BCID2 when compared to standard culture (88% each). BCID2 correctly identified 100% of target organisms. There were 10 (12%) isolates that only grew in culture that were not BCID or BCID2 targets. Compared to BCID, BCID2 was able to detect to the species level on 23 additional isolates. Most notably, 3 Enterococcus faecalis isolates were detected on BCID2, which would have resulted in a theoretical decrease in time to optimal antimicrobial therapy. Three CTX-M genes were detected on the resistance panels for Enteric bacteria, which could have resulted in a theoretical decrease in time to effective therapy. Conclusion BioFire BCID2 had equal rates of detection when compared to BCID in pediatric patients. It has the additional advantage of detecting more organisms at the species level, with clinical significance for Enterococcus faecalis specifically. With the additional resistance genes, it also has the potential to impact care with early identification of ESBL-producing Enteric pathogens. Disclosures Kelly E. Graff, MD, BioFire Diagnostics, LLC (Grant/Research Support) Claire Palmer, MS, BioFire Diagnostics, LLC (Grant/Research Support) Toraj Anarestani, MT(ASCP), BioFire Diagnostics, LLC (Grant/Research Support) Darcy Velasquez, MS, MB (ASCP)CM, BioFire Diagnostics, LLC (Grant/Research Support) Stacey Hamilton, MT(ASCP)SM, BioFire Diagnostics, LLC (Grant/Research Support) Kristin Pretty, n/a, BioFire Diagnostics, LLC (Grant/Research Support) Samuel Dominguez, MD, PhD, BioFire (Consultant, Research Grant or Support)

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