scholarly journals Randomized Trial Evaluating Clinical Impact of RAPid IDentification and Susceptibility Testing for Gram-negative Bacteremia: RAPIDS-GN

2020 ◽  
Author(s):  
Ritu Banerjee ◽  
Lauren Komarow ◽  
Abinash Virk ◽  
Nipunie Rajapakse ◽  
Audrey N Schuetz ◽  
...  
Keyword(s):  
Blood Culture ◽  
Susceptibility Testing ◽  
Controlled Trial ◽  
Bloodstream Infections ◽  
Standard Of Care ◽  
Rapid Identification ◽  
Gram Negative ◽  
Soc Testing ◽  
Multicenter Randomized Controlled Trial ◽  
Gram Negative Bacteremia

Abstract Background Rapid blood culture diagnostics are of unclear benefit for patients with gram-negative bacilli (GNB) bloodstream infections (BSIs). We conducted a multicenter, randomized, controlled trial comparing outcomes of patients with GNB BSIs who had blood culture testing with standard-of-care (SOC) culture and antimicrobial susceptibility testing (AST) vs rapid organism identification (ID) and phenotypic AST using the Accelerate Pheno System (RAPID). Methods Patients with positive blood cultures with Gram stains showing GNB were randomized to SOC testing with antimicrobial stewardship (AS) review or RAPID with AS. The primary outcome was time to first antibiotic modification within 72 hours of randomization. Results Of 500 randomized patients, 448 were included (226 SOC, 222 RAPID). Mean (standard deviation) time to results was faster for RAPID than SOC for organism ID (2.7 [1.2] vs 11.7 [10.5] hours; P < .001) and AST (13.5 [56] vs 44.9 [12.1] hours; P < .001). Median (interquartile range [IQR]) time to first antibiotic modification was faster in the RAPID arm vs the SOC arm for overall antibiotics (8.6 [2.6–27.6] vs 14.9 [3.3–41.1] hours; P = .02) and gram-negative antibiotics (17.3 [4.9–72] vs 42.1 [10.1–72] hours; P < .001). Median (IQR) time to antibiotic escalation was faster in the RAPID arm vs the SOC arm for antimicrobial-resistant BSIs (18.4 [5.8–72] vs 61.7 [30.4–72] hours; P = .01). There were no differences between the arms in patient outcomes. Conclusions Rapid organism ID and phenotypic AST led to faster changes in antibiotic therapy for gram-negative BSIs. Clinical Trials Registration NCT03218397.

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 90. Impact of Discrepant Rapid Diagnostic Test (RDT) Results on Antimicrobial Stewardship Program (ASP) Interventions in Patients with Bloodstream Infections (BSI) due to Gram-Negative Bacilli (GNB)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S61-S61
Author(s):  
Evan D Robinson ◽  
Heather L Cox ◽  
April E Attai ◽  
Lindsay Donohue ◽  
Megan Shah ◽  
...  
Keyword(s):  
Susceptibility Testing ◽  
Bloodstream Infections ◽  
Standard Of Care ◽  
First Year ◽  
Beta Lactam ◽  
Gram Negative ◽  
Stewardship Program ◽  
Few Data ◽  
The Impact

Abstract Background Implementation of the Accelerate PhenoTM Gram-negative platform (AXDX) paired with ASP intervention projects to improve time to definitive institutional-preferred antimicrobial therapy (IPT). However, few data describe the impact of discrepant RDT results from standard of care (SOC) methods on antimicrobial prescribing. Here we evaluate the prescribing outcomes for discrepant results following the first year of AXDX + ASP implementation. Methods Consecutive, non-duplicate blood cultures for adult inpatients with GNB BSI following combined RDT + ASP intervention were included (July 2018 – July 2019). AXDX results were emailed to the ASP in real time then released into the EMR upon ASP review and communication with the treating team. SOC identification (ID; Vitek® MS/Vitek® 2) and antimicrobial susceptibility testing (AST; Trek SensititreTM) followed RDT as the reference standard. IPT was defined as the narrowest susceptible beta-lactam, and a discrepancy was characterized when there was categorical disagreement between RDT and SOC methods. When IPT by AXDX was found to be non-susceptible on SOC, this was characterized as “false susceptible“. Conversely, “false resistance” was assessed when a narrower-spectrum agent was susceptible by SOC. Results were also deemed discrepant when the AXDX provided no/incorrect ID for on-panel organisms, no AST, or a polymicrobial specimen was missed. Results Sixty-nine of 250 patients (28%) had a discrepancy in organism ID or AST: false resistance (9%), false susceptible (5%), no AST (5%), no ID (4%), incorrect ID (2%), and missed polymicrobial (2%). A prescribing impact occurred in 55% of cases (Table 1), where unnecessarily broad therapy was continued most often. Erroneous escalation (7%) and de-escalation to inactive therapy (7%) occurred less frequently. In-hospital mortality occurred in 4 cases, none of which followed an inappropriate transition to inactive therapy. Conclusion Though the AXDX platform provides rapid ID and AST results, close coordination with Clinical Microbiology and continued ASP follow up are needed to optimize therapy. Although uncommon, the potential for erroneous ASP recommendations to de-escalate to inactive therapy following AXDX results warrants further investigation. Disclosures Amy J. Mathers, MD, D(ABMM), Accelerate Diagnostics (Consultant)

scholarly journals Evaluation of the impact of the Accelerate Pheno™ system on time to result for differing antimicrobial stewardship intervention models in patients with gram-negative bloodstream infections

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Gerald Elliott ◽  
Michael Malczynski ◽  
Viktorjia O. Barr ◽  
Doaa Aljefri ◽  
David Martin ◽  
...  
Keyword(s):  
Antimicrobial Stewardship ◽  
Bloodstream Infections ◽  
Standard Of Care ◽  
Resistance Mechanisms ◽  
Gram Negative ◽  
Intervention Models ◽  
Gram Negative Bacteremia ◽  
Potential Impact ◽  
Potential Clinical Impact ◽  
The Impact

Abstract Background Initiating early effective antimicrobial therapy is the most important intervention demonstrated to decrease mortality in patients with gram-negative bacteremia with sepsis. Rapid MIC-based susceptibility results make it possible to optimize antimicrobial use through both escalation and de-escalation. Method We prospectively evaluated the performance of the Accelerate Pheno™ system (AXDX) for identification and susceptibility testing of gram-negative species and compared the time to result between AXDX and routine standard of care (SOC) using 82 patient samples and 18 challenge organisms with various confirmed resistance mechanisms. The potential impact of AXDX on time to antimicrobial optimization was investigated with various simulated antimicrobial stewardship (ASTEW) intervention models. Results The overall positive and negative percent agreement of AXDX for identification were 100 and 99.9%, respectively. Compared to VITEK® 2, the overall essential agreement was 96.1% and categorical agreement was 95.4%. No very major or major errors were detected. AXDX reduced the time to identification by an average of 11.8 h and time to susceptibility by an average of 36.7 h. In 27 patients evaluated for potential clinical impact of AXDX on antimicrobial optimization, 18 (67%) patients could potentially have had therapy optimized sooner with an average of 18.1 h reduction in time to optimal therapy. Conclusion Utilization of AXDX coupled with simulated ASTEW intervention notification substantially shortened the time to potential antimicrobial optimization in this cohort of patients with gram-negative bacteremia. This improvement in time occurred when ASTEW support was limited to an 8-h coverage model.

scholarly journals Evaluation of the Accelerate Pheno System for Fast Identification and Antimicrobial Susceptibility Testing from Positive Blood Cultures in Bloodstream Infections Caused by Gram-Negative Pathogens

2017 ◽  
Vol 55 (7) ◽  
pp. 2116-2126 ◽  
Author(s):  
Matthias Marschal ◽  
Johanna Bachmaier ◽  
Ingo Autenrieth ◽  
Philipp Oberhettinger ◽  
Matthias Willmann ◽  
...  
Keyword(s):  
Blood Culture ◽  
Antimicrobial Susceptibility ◽  
Susceptibility Testing ◽  
Bloodstream Infections ◽  
Test System ◽  
Blood Cultures ◽  
Antimicrobial Susceptibility Testing ◽  
Diagnostic Tools ◽  
Gram Negative ◽  
Content Type

ABSTRACT Bloodstream infections (BSI) are an important cause of morbidity and mortality. Increasing rates of antimicrobial-resistant pathogens limit treatment options, prompting an empirical use of broad-range antibiotics. Fast and reliable diagnostic tools are needed to provide adequate therapy in a timely manner and to enable a de-escalation of treatment. The Accelerate Pheno system (Accelerate Diagnostics, USA) is a fully automated test system that performs both identification and antimicrobial susceptibility testing (AST) directly from positive blood cultures within approximately 7 h. In total, 115 episodes of BSI with Gram-negative bacteria were included in our study and compared to conventional culture-based methods. The Accelerate Pheno system correctly identified 88.7% (102 of 115) of all BSI episodes and 97.1% (102 of 105) of isolates that are covered by the system's identification panel. The Accelerate Pheno system generated an AST result for 91.3% (95 of 104) samples in which the Accelerate Pheno system identified a Gram-negative pathogen. The overall category agreement between the Accelerate Pheno system and culture-based AST was 96.4%, the rates for minor discrepancies 1.4%, major discrepancies 2.3%, and very major discrepancies 1.0%. Of note, ceftriaxone, piperacillin-tazobactam, and carbapenem resistance was correctly detected in blood culture specimens with extended-spectrum beta-lactamase-producing Escherichia coli ( n = 7) and multidrug-resistant Pseudomonas aeruginosa ( n = 3) strains. The utilization of the Accelerate Pheno system reduced the time to result for identification by 27.49 h ( P < 0.0001) and for AST by 40.39 h ( P < 0.0001) compared to culture-based methods in our laboratory setting. In conclusion, the Accelerate Pheno system provided fast, reliable results while significantly improving turnaround time in blood culture diagnostics of Gram-negative BSI.

scholarly journals Current Trends of Gram-negative Bacteremia in a State of North India, the Forthcoming Challenges IGMC Shimla

2021 ◽  
pp. 21-27
Author(s):  
Pankaj Katoch ◽  
Anil Kanga
Keyword(s):  
Blood Culture ◽  
Critical Role ◽  
Tertiary Care ◽  
Age Groups ◽  
Bloodstream Infections ◽  
North India ◽  
Gram Negative Bacteria ◽  
Bacterial Isolates ◽  
Gram Negative ◽  
Gram Negative Bacteremia

Background: Vascular endothelial dysfunction plays a critical role in the evolution of sepsis there is an increase in vascular permeability leading to coagulation abnormalities and subsequent dysfunction of major organs.1 Bloodstream infections are a cause of life-threatening complications in all age groups of the population especially the extreme age groups who are very much prone to the risk. Antibiotic usage is associated with bacteremia, septicemia, and mortality through many factors. We are aware that Gram-negative bacteria due to many causes are becoming increasingly resistant to the currently used antimicrobial therapy. Here, in this study, we report the incidence and etiology and of the Gram-Negative bacterial isolates and their clinical significance from our tertiary care institute located in the Northern part of India. Materials and Methods: Prospective Observational Study conducted in the Department of Microbiology IGMC Shimla for a tenure of one year to determine the incidence and etiology of Gram-negative bacterial isolates and their antimicrobial resistance profile. All the blood culture samples received in the Department of Microbiology IGMC Shimla for culture by Bactec Bd fx from July 2015 to June 2016 were included in the study except for falling in the exclusion criteria. The blood culture was observed in the Bactec bd fx system for at least 5 days before they are reported as sterile. Results: Among the total 1275 cultures which were positive for bacteria, 931(73.02%) were positive for Gram-negative bacteria. Among the total of 931culture that were positive for Gram-negative bacteria, The Non-fermenter group of organisms was isolated in 292(31.36%) cultures, followed by E. coli 266(28.57%). Among the total of 931 cultures positive for GNB, a maximum of 335 (35.98%) belonged to 0-1 year. Among them, 574 (61.65%) were males while 357 (38.35%) were females. Conclusion: Nonfermenter group was the commonest organism among Gram-negative isolates. Infants were more commonly positive as compared to another age group. Males were more commonly culture positive as compared to females among gram-negative isolates.

scholarly journals Clinical Effect of Expedited Pathogen Identification and Susceptibility Testing for Gram-Negative Bacteremia and Candidemia by Use of the Accelerate PhenoTM System

2019 ◽  
Vol 3 (4) ◽  
pp. 569-579 ◽  
Author(s):  
Jason P Burnham ◽  
Meghan A Wallace ◽  
Brian M Fuller ◽  
Angela Shupe ◽  
Carey-Ann D Burnham ◽  
...  
Keyword(s):  
Median Time ◽  
Predictive Value ◽  
Susceptibility Testing ◽  
Standard Of Care ◽  
Blood Cultures ◽  
Gram Negative ◽  
Academic Center ◽  
Blood Culture Positivity ◽  
Gram Negative Bacteremia ◽  
Jewish Hospital

Abstract Background Fast diagnostic tests providing earlier identification (ID) of pathogens, and antimicrobial susceptibility testing (AST) may reduce time to appropriate antimicrobial therapy (AAT), decrease mortality, and facilitate antimicrobial deescalation (ADE). Our objective was to determine the theoretical reduction in time to AAT and opportunities for ADE with Accelerate PhenoTM System (AXDX). Methods The prospective cohort (April 14, 2016 through June 1, 2017) was from the Barnes-Jewish Hospital, a 1250-bed academic center. Emergency department (ED) or intensive care unit (ICU) blood cultures Gram-stain positive for gram-negative bacilli (GNB) or yeast. AXDX was used in parallel with standard-of-care (SOC) diagnostics to determine differences in time to pathogen ID and AST. Theoretical opportunities for ADE from AXDX results were determined. Results In total, 429 blood cultures were screened, 153 meeting inclusion criteria: 110 on-panel GNB, 10 Candida glabrata, and 5 Candida albicans. For GNB SOC, median time from blood culture positivity to ID and AST were 28.2 and 52.1 h. Median time to ID and AST after AXDX initiation was 1.37 and 6.7 h for on-panel organisms. For on-panel Candida, time to ID was approximately 21 h faster with AXDX. ADE or AAT was theoretically possible with AXDX in 48.4%. Of on-panel organisms, 24.0% did not receive initial AAT. In-hospital mortality was 46.7% without initial AAT, and 11.6% with AAT. Coverage of AXDX was 75.3%, specificity 99.7%, positive predictive value (PPV) 96.0%, and negative predictive value (NPV) 97.6%. On-panel sensitivity was 91.5%, specificity 99.6%, PPV 96.0%, and NPV 99.0%. Conclusions AXDX provides more rapid ID and AST for GNB and ID for yeast than SOC. AXDX could potentially reduce time to AAT and facilitate ADE.

scholarly journals Evaluation of the ePlex Blood Culture Identification Panels for Detection of Pathogens in Bloodstream Infections

2018 ◽  
Vol 57 (2) ◽  
Author(s):  
Te-Din Huang ◽  
Ekaterina Melnik ◽  
Pierre Bogaerts ◽  
Stephanie Evrard ◽  
Youri Glupczynski
Keyword(s):  
Blood Culture ◽  
Positive Blood Culture ◽  
Fungal Pathogens ◽  
Bacterial Resistance ◽  
Bloodstream Infections ◽  
Rapid Identification ◽  
Added Value ◽  
Gram Positive ◽  
Gram Negative ◽  
Culture Identification

ABSTRACT Rapid identification and susceptibility testing results are of importance for the early appropriate therapy of bloodstream infections. The ePlex (GenMark Diagnostics) blood culture identification (BCID) panels are fully automated PCR-based assays designed to identify Gram-positive and Gram-negative bacteria, fungi, and bacterial resistance genes within 1.5 h from positive blood culture. Consecutive non-duplicate positive blood culture episodes were tested by the ePlex system prospectively. The choice of panel(s) (Gram-positive, Gram-negative, and/or fungal pathogens) was defined by Gram-stained microscopy of blood culture-positive bottles (BacT/Alert; bioMérieux). Results with the ePlex panels were compared to the identification results obtained by standard culture-based workflow. In total, 216 positive blood culture episodes were evaluable, yielding 263 identification results. The sensitivity/positive predictive value for detection by the ePlex panels of targeted cultured isolates were 97% and 99% for the Gram-positive panel and 99% and 96% for the Gram-negative panel, resulting in overall agreement rates of 96% and 94% for the Gram-positive and Gram-negative panel, respectively. All 26 samples with targeted resistance results were correctly detected by the ePlex panels. The ePlex panels provided highly accurate results and proved to be an excellent diagnostic tool for the rapid identification of pathogens causing bloodstream infections. The short time to results may be of added value for optimizing the clinical management of patients with sepsis.

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