scholarly journals 746. Clinical and Microbiological Characteristics of Clostridioides difficile Infection After a Change in Diagnostic Testing Algorithm

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S470-S471
Author(s):  
Andrew S Crone ◽  
Andrew M Skinner ◽  
Adam Cheknis ◽  
Stuart Johnson ◽  
Susan M Pacheco
Keyword(s):  
Diagnostic Testing ◽  
Laboratory Data ◽  
Panel Member ◽  
Restriction Endonuclease Analysis ◽  
Review Panel ◽  
Cycle Threshold ◽  
Clostridioides Difficile ◽  
Microbiological Characteristics ◽  
Clostridioides Difficile Infection ◽  
Testing Algorithm

Abstract Background There is a lack of consensus on the most appropriate testing for C. difficile infection (CDI). The objective of this study was to determine the clinical and microbiological characteristics of CDI following a switch from stool PCR testing only to PCR reflexed to toxin testing. Figure 1. PCR Cycle Threshold Values Methods We reviewed the characteristics and outcomes of 50 consecutive patients who tested positive for CD by PCR (Xpert CD, Cepheid) between October 2019 and January 2020 at the Hines VA Hospital. Cases were defined by results of reflex toxin testing (Cdiff quick check complete, Alere/TechLab) after a positive PCR result. Baseline characteristics, symptoms, initial laboratory data, and treatments were compared as well as patient outcomes, including hospital readmission due to CDI at 30 days, and recurrent CDI (rCDI) at 30 and 90 days. The cycle threshold for the stool PCR result was recorded. Stools were cultured anaerobically for CD, and restriction endonuclease analysis (REA) strain typing was performed on the recovered CD isolates. Results Toxin testing was positive in 19/50 (38%) cases. Compared to stool toxin-negative cases, toxin-positive cases were older (95% vs. 71% were age ≥ 65, p = 0.06), more likely to have a history of CDI (37% vs. 23%, p = 0.34), and have ≥ 1 CDI episodes within 6 months (37% vs. 19%, p = 0.26). Treatment for CDI was more common in patients who had a positive toxin text. (95% vs 61%, p= 0.009). Among the 38 patients that received treatment, 33 received vancomycin (87%) and 8 patients (21%) had rCDI at 30 days. Of the 8 patients with rCDI, 2 were re-admitted to the hospital for CDI. The average PCR cycle threshold was lower in the toxin-positive stools compared to toxin-negative stools (24.46 and 29.96, p< 0.001; Fig. 1) The endemic REA group Y was the most common CD strain recovered (30%) and the previously epidemic and virulent REA group BI strain was recovered in 11% of the cases. Conclusion CDI cases diagnosed by positive stool PCR and positive toxin tests had more typical risk factors for CDI, a lower PCR cycle threshold and were more likely to have been treated for CDI. Outcomes were similar in this setting where infection with the virulent BI strain was uncommon. Disclosures Stuart Johnson, MD, Acurx Pharmaceuticals (Advisor or Review Panel member)Bio-K+ (Advisor or Review Panel member)Ferring Pharmaceutical (Advisor or Review Panel member)

scholarly journals Evaluation of Cycle Threshold, Toxin Concentration, and Clinical Characteristics of Clostridioides difficile Infection in Patients with Discordant Diagnostic Test Results

2020 ◽  
Vol 58 (5) ◽  
Author(s):  
Megan D. Shah ◽  
Joan-Miquel Balada-Llasat ◽  
Kelci Coe ◽  
Erica Reed ◽  
Johanna Sandlund ◽  
...  
Keyword(s):  
Clinical Characteristics ◽  
Laboratory Data ◽  
Antibiotic Use ◽  
Neutralization Assay ◽  
Test Results ◽  
Toxin Concentration ◽  
Content Type ◽  
Cycle Threshold ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

ABSTRACT Clostridioides difficile infection (CDI) is one of the most common health care-associated infections that can cause significant morbidity and mortality. CDI diagnosis involves laboratory testing in conjunction with clinical assessment. The objective of this study was to assess the performance of various C. difficile tests and to compare clinical characteristics, Xpert C. difficile/Epi (PCR) cycle threshold (CT), and Singulex Clarity C. diff toxins A/B (Clarity) concentrations between groups with discordant test results. Unformed stool specimens from 200 hospitalized adults (100 PCR positive and 100 negative) were tested by cell cytotoxicity neutralization assay (CCNA), C. diff Quik Chek Complete (Quik Chek), Premier Toxins A and B, and Clarity. Clinical data, including CDI severity and CDI risk factors, were compared between discordant test results. Compared to CCNA, PCR had the highest sensitivity at 100% and Quik Chek had the highest specificity at 100%. Among clinical and laboratory data studied, prevalences of leukocytosis, prior antibiotic use, and hospitalizations were consistently higher across all subgroups in comparisons of toxin-positive to toxin-negative patients. Among PCR-positive samples, the median CT was lower in toxin-positive samples than in toxin-negative samples; however, CT ranges overlapped. Among Clarity-positive samples, the quantitative toxin concentration was significantly higher in toxin-positive samples than in toxin-negative samples as determined by CCNA and Quik Chek Toxin A and B. Laboratory tests for CDI vary in sensitivity and specificity. The quantitative toxin concentration may offer value in guiding CDI diagnosis and treatment. The presence of leukocytosis, prior antibiotic use, and previous hospitalizations may assist with CDI diagnosis, while other clinical parameters may not be consistently reliable.

scholarly journals 766. Readmissions of Hospitalized Patients with Clostridioides difficile Infection (CDI) for Recurrent CDI Is Common

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S480-S480
Author(s):  
Emily N Drwiega ◽  
Larry H Danziger ◽  
Stuart Johnson ◽  
Andrew M Skinner
Keyword(s):  
Medical Center ◽  
Hospital Readmissions ◽  
Panel Member ◽  
Hospitalized Patients ◽  
Recurrent Episode ◽  
Review Panel ◽  
Infectious Disease Physician ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

Abstract Background Hospital acquired infections (HAI) and hospital readmissions are of particular focus by Centers for Medicare and Medicaid Services. Clostridioides difficile infection (CDI) is an HAI notorious for causing recurrent illness and potentially resulting in re-hospitalizations. The purpose of our study was to identify the frequency of follow-up appointments in patients with CDI and determine the rate of re-hospitalization for recurrent CDI (rCDI). Methods This was a single-center, retrospective, chart review at a tertiary medical center. Through the electronic medical record, we queried all hospitalized patients with a positive stool test for C. difficile (GI panel PCR, FilmArray, Biofire, or C. difficile PCR, Xpert CD assay, Cepheid) with or without an ICD-10 code Enterocolitis due to C. difficile (A04.7, A04.71, A04.72) from January 2018 through April 2018. Demographic and clinical data at the time of diagnosis and up to 90 days after were collected from patient records. Results One-hundred and eighty-five patient episodes were evaluated. Of these, 147 (79.5%) were primary CDI, 13 (7.0%) were rCDI, and 25 (13.5%) were determined to be colonization. Twenty-two (11.9%) patients from the total cohort attended a follow-up appointment for CDI within 30 days, most often with a primary care provider or infectious disease physician. Twenty-three (12.4%) patients, 18 of whom were hospitalized for primary CDI episodes, developed a recurrent episode within 90 days of their initial CDI episode. Of these 23 patients with rCDI, 10 (43.5%) patients were re-hospitalized for their rCDI. Only 4 (17.4%) patients with rCDI had a follow-up appointment after their primary episode and among the 10 patients re-hospitalized for rCDI, only 2 (20.0%) patient had been seen for follow up for their previous CDI episode. Conclusion In our study, few patients had a follow-up appointment for CDI. Also, more than one third of the patients who had rCDI had to be re-hospitalized for the recurrent episode. Our study highlights a concern that the majority of patients re-hospitalized with rCDI did not have a follow-up appointment within 30 days of their initial diagnosis. Further study is necessary to determine if a dedicated follow-up appointment for CDI would result in decreased re-hospitalizations associated with rCDI. Disclosures Stuart Johnson, MD, Acurx Pharmaceuticals (Advisor or Review Panel member)Bio-K+ (Advisor or Review Panel member)Ferring Pharmaceutical (Advisor or Review Panel member)

scholarly journals 2353. Easy Does It: Decreasing and Sustained Hospital-Onset (HO) CDI Lab-ID Event Incidence Through a Series of Interventions

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S809-S810
Author(s):  
Rachael A Lee ◽  
Jeremey Walker ◽  
Elizabeth Freeze ◽  
Rashida Khalid ◽  
Bernard Camins
Keyword(s):  
Care Center ◽  
Tertiary Care ◽  
Diagnostic Testing ◽  
Computer Assisted ◽  
Oncology Patient ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
The Difference ◽  
Testing Algorithm ◽  
Main Component

Abstract Background Clostridioides difficile infection (CDI) Laboratory (Lab) identified (ID) events are reportable to CMS through the CDC’s NHSN. Prevention of transmission has been the main component of interventions; however, avoiding false-positive laboratory diagnoses can also lead to decreased incidence. Methods A retrospective analysis of HO-CDI Lab-ID events was conducted to evaluate the results of a series of interventions at the University of Alabama Hospital, a 1150-bed tertiary care center in Birmingham, AL. The study period was from the first quarter of 2013 (1Q 2013) until 1Q of 2019. Interventions were implemented in sequential order were: (i) CDI prevention bundle education (3Q 2014); (ii) two-step laboratory testing algorithm (2Q 2015); (iii) selective enhanced environmental disinfection on oncology units (2Q 2016); (iv) diagnostic stewardship by reminding providers to reconsider testing if the patient received a laxative within 48 hours (4Q 2016). Results At the beginning of the study period, the HO CDI Lab ID Event SIR was 0.96. The standard infection ratio (SIR) over the time period is shown in Figure 1. We observed a slight decrease in HO-CDI Lab ID event SIR after implementation of the CDI prevention bundle (0.96 vs. 0.77). A change in the diagnostic testing from PCR-based to a two-step algorithm (EIA testing for GDH and Toxin confirmed by PCR) resulted in a slight increase although not statistically significant (0.77 vs. 0.83). A downward trend was observed when selective enhanced terminal disinfection with hydrogen peroxide vapor was performed on all oncology patient rooms vacated by patients with CDI (0.83 vs. 0.72). The largest and sustained impact was observed after implementation of a computer-assisted diagnostic stewardship in which providers were reminded if the patient was administered any stool softener or laxative within 48 hours of the order for CDI testing (0.72 vs. 0.32). The institutions SIR value became significant in 2Q 2016 (P = 0.0014) and significance was maintained since that time. The difference between expected and observe HO-CDI Lab ID events is demonstrated in Figure 2. Conclusion Through a series of interventions, we observed a decrease in HO-CDI event rates. Diagnostic stewardship with academic detailing resulted in the most impactful and sustained improvement. Disclosures All authors: No reported disclosures.

scholarly journals 2373. Impact of a Change in Testing Strategy for Clostridioides difficile Infection on a Publicly Reported Metric and Treatment Days of Therapy

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S818-S819
Author(s):  
Ryan Miller ◽  
Jose A Morillas ◽  
Joanne Sitaras ◽  
Jacob Bako ◽  
Elizabeth A Neuner ◽  
...  
Keyword(s):  
Health System ◽  
Diagnostic Testing ◽  
Cleveland Clinic ◽  
Public Reporting ◽  
Testing Strategy ◽  
Clostridioides Difficile ◽  
Days Of Therapy ◽  
Before And After ◽  
Clostridioides Difficile Infection ◽  
The Impact

Abstract Background In an effort to optimize diagnostic testing for Clostridioides difficile infection (CDI) our health system changed from stand-alone PCR testing to a “2-step” approach wherein all positive PCR results reflexed to an EIA. We report the effects of this change on publicly reported CDI metrics and treatment days of therapy (DOT). Methods The setting includes 10 Cleveland Clinic Health System hospitals in northeast Ohio and one in Florida. On June 12, 2018, 9 NE Ohio hospitals changed from PCR alone to PCR followed by EIA. Stand-alone PCR testing remained at one and GDH / EIA / PCR for discordant for another. Testing volumes were obtained from the microbiology laboratory. C. difficile LabID event SIRs were obtained from NHSN. Public reporting interpretative categories were identified based on SIR for second half of 2018. DOT for CDI agents were obtained from an antimicrobial stewardship database. Results Among hospitals that changed strategy the volume of PCR testing and the percent PCR + was similar between time periods. EIA positivity ranged from 23% to 53%. 4/11 hospitals improved their public reporting category: 3/9 that changed testing strategy and 1/2 that did not (Table 1). Two of 3 that changed strategy and improved public reporting also had a decrease in DOT. DOT increased in the 2 hospitals that did not change strategy. Conclusion Six months after adopting a 2-step CDI testing strategy 7 of 9 hospitals had a lower SIR with 3 also demonstrating an improvement in public reporting category favorably impacting reputational and reimbursement risk for our healthcare system. CDI agent DOT was similar before and after the change. The impact of choice of test on publicly reported metrics demonstrates the difficulty of utilizing a proxy for hospital onset CDI, the CDI LabID event, as a measure of quality of care provided. Disclosures All authors: No reported disclosures.

scholarly journals GRADING prognostic factors for severe and recurrent Clostridioides difficile infection: expected and unexpected findings. A systematic review.

2021 ◽  
Author(s):  
Tessel Meike van Rossen ◽  
Rogier E. Ooijevaar ◽  
Christina M.J.E. Vandenbroucke-Grauls ◽  
Olaf M. Dekkers ◽  
Ed J. Kuijper ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Prognostic Factors ◽  
Laboratory Data ◽  
Final Analysis ◽  
Cochrane Library ◽  
Case Control Studies ◽  
Clostridioides Difficile ◽  
Increased Risk ◽  
Clostridioides Difficile Infection

Background Clostridioides difficile infection (CDI), its subsequent recurrences (rCDI), and severe CDI (sCDI) provide a significant burden for both patients and the healthcare system. Treatment consists of oral antibiotics. Fidaxomicin, bezlotoxumab and fecal microbiota transplantion (FMT) reduce the number of recurrences compared to vancomycin, but are more costly. Identifying patients diagnosed with initial CDI who are at increased risk of developing sCDI/rCDI could lead to more cost-effective therapeutic choices. Objectives In this systematic review we aimed to identify clinical prognostic factors associated with an increased risk of developing sCDI or rCDI. Methods PubMed, Embase, Emcare, Web of Science and COCHRANE Library databases were searched from database inception through March, 2021. Study selection was performed by two independent reviewers on the basis of predefined selection criteria; conflicts were resolved by consensus. Cohort and case-control studies providing an analysis of clinical or laboratory data to predict sCDI/rCDI in patients ≥18 years diagnosed with CDI, were included. Risk of bias was assessed with the Quality in Prognostic Research (QUIPS) tool and the quality of evidence by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool, modified for prognostic studies. Overview tables of prognostic factors were constructed to assess the number of studies and the respective direction of an association (positive, negative, or no association). Results and conclusions 136 studies were included for final analysis. Higher age and the presence of multiple comorbidities were prognostic factors for sCDI. Identified risk factors for rCDI were higher age, healthcare-associated CDI, prior hospitalization, PPIs started during/after CDI diagnosis and previous rCDI. Some variables that were found as risk factors for sCDI/rCDI in previous reviews were not confirmed in the current review, which can be attributed to differences in methodology. Risk stratification for sCDI/rCDI may contribute to a more personalized and optimal treatment for patients with CDI.

Sequential introduction of a multistep testing algorithm and nucleic acid amplification testing leading to an increase in Clostridioides difficile detection and a trend toward increased strain diversity

2020 ◽  
Vol 41 (10) ◽  
pp. 1148-1153
Author(s):  
Andrew M. Skinner ◽  
Brian Yu ◽  
Adam Cheknis ◽  
Susan M. Pacheco ◽  
Dale N. Gerding ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Restriction Endonuclease Analysis ◽  
Nucleic Acid Amplification ◽  
Toxin Concentration ◽  
Detection Rates ◽  
Strain Diversity ◽  
Clostridioides Difficile ◽  
Nucleic Acid Amplification Testing ◽  
Testing Algorithm

AbstractBackground:Most clinical microbiology laboratories have replaced toxin immunoassay (EIA) alone with multistep testing (MST) protocols or nucleic acid amplification testing (NAAT) alone for the detection of C. difficile.Objective:Study the effect of changing testing strategies on C. difficile detection and strain diversity.Design:Retrospective study.Setting:A Veterans’ Affairs hospital.Methods:Initially, toxin EIA testing was replaced by an MST approach utilizing a glutamate dehydrogenase (GDH) and toxin EIA followed by tcdB NAAT for discordant results. After 18 months, MST was replaced by a NAAT-only strategy. Available patient stool specimens were cultured for C. difficile. Restriction endonuclease analysis (REA) strain typing and quantitative in vitro toxin testing were performed on recovered isolates.Results:Before MST (toxin EIA), 79 of 708 specimens (11%) were positive, and after MST (MST-A), 121 of 517 specimens (23%) were positive (P < .0001). Prior to NAAT-only testing (MST-B), 80 of the 490 specimens (16%) were positive by MST, and after NAAT-only testing was implemented, 67 of the 368 specimens (18%) were positive (P = nonsignificant). After replacing toxin EIA testing, REA strain group diversity increased (8, 13, 13, and 10 REA groups in the toxin EIA, MST-A, MST-B, and NAAT-only periods, respectively) and in vitro toxin concentration decreased. The average log10 toxin concentration of the isolates were 2.08, 1.88, 1.20 and 1.55 ng/mL for the same periods, respectively.Conclusions:MST and NAAT had similar detection rates for C. difficile. Compared to toxin testing alone, they detected increased diversity of C. difficile strains, many of which were low toxin producing.

scholarly journals 1331. Reducing Inpatient Antimicrobial Treatment Duration for Febrile Infants through Implementation of Rapid Diagnostic Testing and Clinical Risk Definition

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S676-S677
Author(s):  
Guliz Erdem ◽  
Joshua Watson ◽  
Don Buckingham ◽  
Octavio Ramilo ◽  
William J Barson
Keyword(s):  
Antibiotic Treatment ◽  
Treatment Duration ◽  
Diagnostic Testing ◽  
Panel Member ◽  
Antimicrobial Treatment ◽  
Management Guideline ◽  
Research Support ◽  
Readmission Rates ◽  
Review Panel ◽  
Length Of Hospitalization

Abstract Background The management approach to febrile infants remain challenging. Despite new advances in rapid diagnostic testing, febrile infants with a viral infection could receive prolonged antimicrobial treatment due to concerns for co-existing serious bacterial infection (SBI). We sought to decrease the duration of antibiotic treatment in febrile infants less than 8 weeks of age hospitalized on inpatient infectious disease service following sepsis evaluation, who have enterovirus, parechovirus, or respiratory viruses detected, from average 30 hours to 24 hours and sustain for six months. Figure 1. Antibiotic Treatment Duration of Infants Underfoing Evaluation for Sepsis Figure 2. Length of Stay in Infants Underfoing Sepsis Evaluation Methods A new management guideline that defined “low-risk” infants, as well as inclusion and exclusion criteria, was created to monitor the accurate duration of parenteral treatment and length of hospitalization. Respiratory viruses were detected by a multiplex PCR assay. We created a QlikSense App for further clinical characterization of patients and follow-up. This management guideline was adapted as a quality improvement division initiative. Control charts were used to assess the impact of the interventions. Figure 3. Readmissions in Infants Underfoing Sepsis Evaluation Results The management guideline was developed and implemented by pediatric infectious disease faculty. Febrile infants &lt; 8 weeks of age were included if they had both documented viral infections and sepsis evaluation. 178 infants were admitted with fevers in 2018 and 148 infants were admitted in 2019. The mean inpatient antibiotic treatment duration decreased from 27.7 hours in 2018 to 24.9 hours in 2019 (P &gt; 0.05) (Figure 1). There was no significant difference in length of hospitalization or 30-day readmission rates (Figure 2 and 3). There was no reported readmission for SBI. Conclusion Antibiotic treatment could be discontinued in clinically stable infants with a documented viral infection after 24 hours of negative blood, CSF, and urine bacterial culture incubation so as not to receive unnecessary prolonged inpatient treatment that may increase side effects. In addition to possible decreased treatment side effects our protocol led to decreased patient care costs with no documented changes in readmission rates. Disclosures Octavio Ramilo, MD, Bill & Melinda Gates Foundation (Grant/Research Support)Janssen (Grant/Research Support, Advisor or Review Panel member)Medimmune (Grant/Research Support)Merck (Advisor or Review Panel member)NIH/NIAID (Grant/Research Support)Pfizer (Consultant, Advisor or Review Panel member)Sanofi/Medimmune (Consultant, Advisor or Review Panel member)

scholarly journals 104. Evaluation of a 2-Step Testing Algorithm for Clostridioides difficile Infection

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S66-S67
Author(s):  
Caitlin C Bettger ◽  
Stephanie Giancola ◽  
Robert Cybulski ◽  
Jason Okulicz ◽  
Alice Barsoumian
Keyword(s):  
Medical Center ◽  
Laboratory Data ◽  
Antibiotic Use ◽  
Treatment Decisions ◽  
High Rate ◽  
Clinical Criteria ◽  
Treatment Status ◽  
Clostridioides Difficile ◽  
Stewardship Program ◽  
Clostridioides Difficile Infection

Abstract Background A 2-step testing strategy for diagnosis of Clostridioides difficile infection (CDI) is recommended to limit over-diagnosis when clinical criteria requirements for stool sample submission cannot be enforced. Real-world evaluations of this strategy are limited. Methods The Antimicrobial Stewardship Program at Brooke Army Medical Center, San Antonio, TX, implemented a 2-step CDI algorithm: polymerase chain reaction (PCR) testing followed by toxin enzyme immunoassay (EIA). The goal was to improve diagnosis of CDI and reduce unnecessary antibiotic use. Patients with PCR+ tests from August 2018 to September 2019 were included. Charts were reviewed for demographics, laboratory data, treatment, and outcomes. Cases were grouped based on concordant (PCR+/EIA+) or discordant (PCR+/EIA-) results. To determine factors contributing to treatment decisions, an analysis of discordant cases were compared by treatment status. Groups were compared by Chi-squared, Fisher’s exact, or Mann-Whitney U tests. Results A total of 216 PCR+ tests from 215 patients were recorded. Of these, 155 (71.8%) were discordant. Demographics, laboratory data, and risk factors for CDI were similar between groups (Table 1; p &gt;0.05 for all). Compared to discordant cases, concordant cases were more frequently hospitalized (59% vs 43.9%; p=0.05), had a higher median daily stool count (5 [4–7] vs 4 [2–6], p=0.03), met criteria for severe CDI (33.3% vs 18.7%; p=0.05), received treatment (95.1% vs 66.5%; p&lt; 0.01) and were readmitted in 30 days with CDI (8.3% vs 1.3%; p=0.02). Among discordant cases, median daily stool count was higher in treated vs untreated cases (4 [3–7] vs 3 [1–5], p=0.02). Otherwise, there was no difference in variables according to treatment status (Table 2; p &gt;0.05 for all). Discordant cases with infectious disease (ID) or gastroenterology (GI) consultation had a high rate of treatment (73.9% and 61.1%, respectively). Table 1. Characteristics and outcomes of patients with concordant and discordant tests. Table 2. Characteristics and outcomes of treated and untreated patients with discordant tests. Conclusion Implementation of 2-step strategy reduced antibiotic treatment by nearly 30%. However, the majority of discordant cases were deemed clinically significant and received treatment by providers, including ID or GI specialists. Further studies are needed to determine the unmeasured factors that guide treatment decisions in discordant cases. Disclosures All Authors: No reported disclosures

scholarly journals 4345 Two-step Algorithm for Clostridioides difficile is Inadequate for Differentiating Infection from Colonization in Children

2020 ◽  
Vol 4 (s1) ◽  
pp. 150-150
Author(s):  
Maribeth R Nicholson ◽  
Jacob M Parnell ◽  
Irtiqa Fazili ◽  
Sarah C. Bloch ◽  
D. Borden Lacy ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Care ◽  
Diagnostic Testing ◽  
Neutralization Assay ◽  
Clostridioides Difficile ◽  
Asymptomatic Children ◽  
Study Population ◽  
Step Algorithm ◽  
New Guidelines ◽  
Testing Algorithm

OBJECTIVES/GOALS: In 2017, new guidelines recommended multi-step algorithms for CDI diagnosis, and clinical centers rapidly implemented changes despite limited pediatric data. We assessed a multi-step algorithm using NAAT followed by EIA for ability to differentiate symptomatic CDI from colonization in children. METHODS/STUDY POPULATION: We prospectively enrolled pediatric patients with cancer, cystic fibrosis, or inflammatory bowel disease who were not being tested or treated for CDI and obtained a stool sample for NAAT. If positive by NAAT (colonized), EIA was performed. Children with symptomatic CDI who tested positive by NAAT via the clinical laboratory were also enrolled and EIA performed on residual stool. A functional cell cytotoxicity neutralization assay (CCNA) was performed in addition. RESULTS/ANTICIPATED RESULTS: Of the 138 asymptomatic children enrolled, 24 (17%) were colonized. An additional 37 children with symptomatic CDI were enrolled. Neither EIA positivity (41% versus 21%, P = 0.11) or CCNA positivity (49% versus 46%, P = 0.84) were significantly different between symptomatic versus colonized children. When both EIA and CCNA were positive, children were more commonly symptomatic than colonized (33% versus 13%, P = 0.04). DISCUSSION/SIGNIFICANCE OF IMPACT: A multi-step testing algorithm with NAAT and EIA failed to differentiate symptomatic CDI from colonization in our pediatric cohort. As multi-step algorithms are moved into clinical care, pediatric providers will need to be aware of the continued limitations in diagnostic testing.

scholarly journals Role of Cycle Threshold in Clostridioides difficile Polymerase Chain Reaction Testing as a Predictor of Clinical Outcomes in Patients With Inflammatory Bowel Disease

2019 ◽  
Vol 1 (3) ◽  
Author(s):  
Emily R Jonica ◽  
Carol A Sulis ◽  
Kanupriya Soni ◽  
Michelle Hughes ◽  
Eric Jones ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Severe Infection ◽  
Chain Reaction ◽  
Cycle Threshold ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Inflammatory Bowel ◽  
Polymerase Chain

Abstract Background Distinguishing Clostridioides difficile infection from colonization is challenging in patients with Inflammatory Bowel Disease (IBD). Cycle threshold (Ct), the cutoff for PCR positivity, has been investigated in non-IBD patients. Methods Patients with positive C. difficile PCR (25 IBD, 51 non-IBD) were identified retrospectively. Fifteen-day outcomes were assessed. Results Ct correlated with diarrheal days in non-IBD (P = 0.048), but not IBD patients (P = 0.769). IBD patients had shorter LOS and less severe infection, but more diarrheal days (P &lt; 0.05). Conclusions IBD patients had a milder course but Ct results were not significant. Larger studies are needed to clarify utility of Ct in IBD.

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