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Introduction: Lyme disease is a poorly understood condition which starts with a rash but may continue with chronic fatigue and neurological symptoms. Approximately 1 in 5 early Lyme disease patients have GI symptoms, such as nausea, anorexia, abdominal pain, or diarrhea. Lyme disease is thought to be cased by microbes in the spirochetes phylum transmitted by black legged ticks. Lyme-related healthcare costs in America exceed 1.3 billion dollars annually. Bifidobacteria are known for their beneficial probiotic actions within the human gut microbiome. Their numbers are reduced in severe COVID-19, Clostridioides difficile infection and Inflammatory Bowel Disease. To our knowledge Bifidobacteria levels have not been studied in Lyme disease patients. Given the importance of Bifidobacterium abundance in other diseases, we focused on relative abundance of Bifidobacterium in fecal samples of patients with Lyme disease compared to controls. Method(s): Fecal samples were assessed for relative abundance of Bifidobacterium in Healthy Control subjects without Lyme disease (n=20) compared to patients with Lyme disease (n=39). The average symptom duration in patients with Lyme disease was 5 years and none were on antibiotics 2 weeks prior to sample collection (range of symptoms from 1 month to 20 years, all treated initially with antibiotics).Metagenomics Next Generation sequencing was performed on fecal samples, where DNA samples were extracted and normalized for library downstream analysis using Shotgun Methodology. Mann- Whitney Statistical test was used for comparison. This study was IRB approved. Result(s): Relative Abundance of bifidobacteria was significantly decreased (p< 0.0001) in patients with Lyme disease. Median and interquartile range (IQR) were: Control (Median:4.175%;IQR:1.72-10.27%) and Lyme disease (Median:0.0014%;IQR:0.00%-0.96%)(Figure). 30/39 Lyme disease patients (77%) were found to possess < 1% relative abundance of Bifidobacterium in their stool sample. Of interest only 1/39 samples showed presence of Spirochetes in stool samples. Conclusion(s): This is the first study that demonstrates low levels of Bifidobacteria in patients with chronic Lyme disease. These results raise three questions;whether the disease was caused by 1. the original microbe creating loss of Bifidobacterium 2. baseline low Bifidobacteria due likely to either diet or medications or 3. excessive treatment. Given Lyme disease comprises a gut dysbiosis issue, therapies should also aim at restoration of depleted Bifidobacteria. (Figure Presented).
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Intro: The ongoing pandemic caused by the SARS-CoV-2 virus has brought many new insights into medicine. During the first months of the pandemic, when there were no comprehensive guidelines for precise antimicrobial therapy, empirical overuse of broad-spectrum antibiotics was observed. Which resulted in the development of clostidium infection in certain cases. In our report, we address 83 cases of clostridial colitis in post-covid patients from 3/2020 to 3/2021 and their specific therapy. Method(s): Retrospective analysis of risk factors for clostridial infection and therapy of clostridial colitis. Finding(s): In the period 3/2020-3/2021, 9617 patients were diagnosed with SARS-CoV-2 virus infection in our hospital, of which 1247 were hospitalized. In 83 cases, clostridial colitis occurred during or after the covid infection had resolved. Mortality in this group was 17%, which corresponds to 14 patients. Previous empirical administered antiobiotics in COVID-19 infection contributed to the development of clostridial colitis in case of 22 patients (27%) by clarithromycin, in 14 pacients (17%) by penicillins and by 3rd generation cephalosporins in 9 patients (11%). The average duration of therapy with broad-spectrum antibiotics was 15.63 days (+-8.99). Other risk factors we observed are: PPI use (25%), active malignant disease (10%), previous glucocorticoid therapy (22%). Vancomycin was used in clostridial infection therapy in 47% (39), metronidazole in 31% (25) and fidaxonicin in 7% (6). In the group, we observed recurrence of clostridium difficile infection in 14% of patients and FMT was performed in 6 patients. Conclusion(s): This study shows a higher percentage of clostridial infection in cases of long-term therapy with broad-spectrum antibiotics. It also points to the effect of specific antimicrobial therapy for infection caused by the bacterium Clostridium difficile and the possibility of using fecal bacteriotherapy.Copyright © 2023
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Introduction: Clostridioides difficile infection (CDI) is the most common healthcare-associated infection in the United States (US). Treatment guidelines have evolved resulting in better outcomes however recurrent disease remains a major issue associated with significant morbidity despite best practices. Bezlotoxumab (BEZ) is a fully humanized monoclonal antibody approved by FDA in 2017 for prevention of recurrent CDI (rCDI). Limited real-world data are available regarding BEZ usage outside of clinical trials. In this multicenter study, we aim to report our experience with BEZ at a large healthcare system in northeast US. Method(s): We retrospectively reviewed all consecutive adult patients who received BEZ from 1/2017 until 12/2021 at Yale-New Haven Health System and had at least 90 days of follow up. Data collected for each patient included demographics, medical co-morbidities, adverse events to BEZ and rates of rCDI following BEZ. Result(s): A total of 114 patients were included with a mean age of 67.3 years (range 25-97);74 (64.9%) were female. There has been a recent increased utilization of BEZ with more than half of our sample (n=73, 64%) being since the beginning of COVID-19 pandemic and 38.6% in 2021 alone. Most patients were treated with vancomycin (88.6%) while 11 (9.7%) received fidaxomicin. Median time from most recent CDI episode to BEZ infusion was 22.5 days. Notably, 17.5% were not on active CDI treatment when they received BEZ. 30 (26.3%) received BEZ after initial CDI, 52 (45.6%) had one prior recurrent episode while 32 (28.1%) had 2 or more previous recurrences. Among those who received BEZ, 10 patients (8.8%) experienced 90-day rCDI, of these 9 (90%) had history of at least 1 episode of rCDI. There were no statistically significant differences in baseline characteristics between r-CDI and non-rCDI groups (Table). Furthermore, no statistical difference in rCDI between those who were on CDI treatment at the time of BEZ and those who completed it before BEZ [9/94 (9.6%) vs 1/20 (5.0%);p=0.511]. Conclusion(s): Our real-life data confirms that Bezlotoxumab appears to be safe and effective in preventing rCDI in this population whether given during CDI treatment or after. BEZ represents an important treatment option in this highly morbid population. Further studies are needed to determine the benefit of early administration of BEZ after index CDI in those at risk and to consider utilization shifts following the 2021 ACG updated guideline recommendations advising it's usage.
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Introduction: CARTITUDE-2 (NCT04133636) is a phase 2, multicohort study evaluating cilta-cel, an anti-BCMA CAR-T therapy, in several multiple myeloma (MM) patient (pt) populations. Objective(s): To report updated results with longer follow-up on cohort C pts with previous exposure to a non-cellular anti- BCMA immunotherapy. Method(s): Cohort C pts had progressive MM after treatment (tx) with a proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, and non-cellular BCMA-targeting agent. A single cilta-cel infusion (target dose 0.75x106 CAR+ viable T cells/kg) was administered 5-7 days post lymphodepletion. Primary endpoint was minimal residual disease (MRD) negativity at 10-5. Secondary endpoints included overall response rate (ORR), duration of response (DOR), and adverse events (AEs). Result(s): As of June 1, 2022, 20 pts (13 ADC exposed;7 BsAb exposed) were treated with cilta-cel;4 pts did not receive cilta-cel due to either low cellular yield (n=2, 1 in each group) or death due to progressive disease (PD) prior to dosing (n=2, 1 in each group) and 6 pts received anti-BCMA tx as their last line of therapy (n=4 ADC, n=2 BsAb). During prior anti-BCMA tx, best responses included VGPR (ADC: 2 pts;BsAb: 1 pt), sCR (ADC: 1 pt), and CR (BsAb: 1 pt);the rest had best response of stable disease or PD (1 pt not evaluable). Baseline characteristics are presented in Figure 1A. Median time from last anti- BCMA agent to cilta-cel infusion was 195 d;median administered dose of cilta-cel was 0.65x106 CAR+ viable T cells/kg. At a median follow-up of 18.0 mo, 7/10 evaluable pts (70%) were MRD negative at 10-5 (ADC: 5/7 [71.4%], BsAb: 2/3 [66.7%]). ORR: full cohort, 60%;ADC, 61.5%;BsAb, 57.1% (Figure 1B). Median DOR: full cohort, 12.8 mo;ADC, 12.8 mo;BsAb, 8.2 mo. Median PFS: full cohort, 9.1 mo;ADC, 9.5 mo;BsAb, 5.3 mo. Cilta-cel responders had a shorter median duration of last anti- BCMA agent exposure (29.5 d) compared with non-responders (63.5 d). Responders also had a longer median time from last anti-BCMA tx exposure to apheresis (161.0 d) than non-responders (56.5 d). Most common AEs were hematologic. CRS: n=12 (60%;all Gr1/2), median time to onset 7.5 d, median duration 6.0 d. ICANS: n=4 (20%, 2 Gr3/4), median time to onset 9.0 d, median duration 7.0 d. No patient had movement or neurocognitive tx emergent AE/parkinsonism. There were 12 deaths (PD: 8;COVID-19 pneumonia: 2 [not tx related];subarachnoid hemorrhage: 1 [not tx related];C. difficile colitis: 1 [tx related]). (Figure Presented)(Figure Presented)Conclusions: Pts with heavily pretreated MM and previous exposure to a non-cellular anti-BCMA therapy had favorable responses to cilta-cel. However, depth and DOR appear lower than that seen in anti-BCMA-naive pts treated with cilta-cel (at 27.7 mo, median DOR was not reached in heavily pre-treated but anti-BCMA naive CARTITUDE-1 pts). These data may inform tx plans, including sequencing and washout period between BCMA-targeting agentsCopyright © 2023 American Society for Transplantation and Cellular Therapy
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Hepatitis A is a common viral infection worldwide that is transmitted via the fecal-oral route. Since the introduction of an efficient vaccine, the incidence of infection has decreased but the number of cases has risen due to widespread community outbreaks among unimmunized individuals. Classic symptoms include fever, malaise, dark urine, and jaundice, and are more common in older children and adults. People are often most infectious 14 days prior to and 7 days following the onset of jaundice. We will discuss the case of a young male patient, diagnosed with acute hepatitis A, leading to fulminant hepatitis refractory to conventional therapy and the development of subsequent kidney injury. The medical treatment through the course of hospitalization was challenging and included the use of L-ornithine-L-aspartate and prolonged intermittent hemodialysis, leading to a remarkable outcome. Hepatitis A is usually self-limited and vaccine-preventable;supportive care is often sufficient for treatment, and chronic infection or chronic liver disease rarely develops. However, fulminant hepatitis, although rare, can be very challenging to manage as in the case of our patient.Copyright © 2023 The Author(s).
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IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). For the first time since the COVID-19 public health emergency began, IDWeek 2022 returned to in-person attendance. It was held in Washington, D.C., and the meeting comprised 5 days of live sessions and on-demand content that included posters and oral presentations.Copyright © 2023 Clarivate.
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Currently, there is a lack of evidence for empiric use of antimicrobial agents in most patients with COVID-19 in outpatient and hospital settings as the overall proportion of secondary bacterial infections in COVID-19 is quite low. This literature review summarizes data on changes in antimicrobial resistance over the course of COVID-19 pandemic, especially in nosocomial ESKAPE pathogens. The other significant consequences of excessive and unnecessary administration of antibiotics to COVID-19 patients including risk of Clostridioides difficile infection and adverse effects of antimicrobial agents are also discussed.Copyright © 2022, Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy. All rights reserved.
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Background: Lorigerlimab (MGD019) is an investigational, bispecific Fc-bearing (IgG4) DART molecule designed to enhance CTLA-4 blockade on dual expressing, tumor infiltrating lymphocytes, while maintaining maximal PD-1 blockade on PD-1 expressing cells. Lorigerlimab has approximate dose proportional PK across 1-10 mg/kg IV dosing Q3W, with sustained PD-1 receptor occupancy evident at doses >=1 mg/kg Q3W. MGD019-01 is a global first-in-human dose finding and activity estimating study of lorigerlimab in advanced solid tumors (AST). Method(s): The exp phase of MGD019-01 evaluates single agent safety, PK, and antitumor effects of lorigerlimab at the recommended dose for exp of 6 mg/ kg IV Q3W in 4 tumor specific cohorts. Confirmed responses were noted in each cohort. Preliminary results of the mCRPC cohort are reported here. Response evaluable pts received >=1 dose and had >=1 postbaseline imaging evaluation. Measurable lesions were evaluated per RECIST v1.1 and skeletal metastases assessed by bone scan. Prostate specific antigen (PSA) response was defined as a >=50% (PSA50) or>=90% (PSA90) PSA decline from baseline with confirmation>=3 weeks later. Expression of proliferation marker, Ki67, and inducible costimulator (ICOS) by peripheral T cells was assessed by flow cytometry. Result(s): At data cutoff (9/10/22), 127 pts with AST received >=1 dose of lorigerlimab 6 mg/ kg. Median exposure was 10 weeks (range, 0.1, 94.4) with median of 4 infusions. 6 pts remain on therapy;36 discontinued for PD (n=13), AEs (n=17), or patient/physician decision (n=6). Treatment related adverse events (TRAE) occurred in 109/127 (85.8%) pts. TRAEs occurring in>=15% of pts were fatigue, pruritus, hypothyroidism, pyrexia. Rates of grade >=3 TRAEs and immune-related AEs were 32.3% and 7.9%, respectively. AEs leading to drug discontinuation occurred in 22.8% of pts. There were no fatal AEs related to lorigerlimab. In the mCRPC exp cohort (n=42), pts had a median of 2 prior lines of therapy for CRPC, >80% received prior ART or taxanes;88% had visceral (liver, 26%;lung, 26%) or nodal disease and 95% had bone metastases. 42 pts were PSA response evaluable;35 were RECIST evaluable. ORR was 25.7% (9/35;9 confirmed PRs). Median duration of response was 16.1 weeks (range 6-25+ weeks). 5 responders remain on study, 4 discontinued for unrelated fatal AEs: COVID-19 (2) cardiac arrest (1) C. difficile infection (1). Confirmed PSA50 and PSA90 response rates were 28.6%(12/42) and 21.4% (9/42), respectively. Increased frequencies of Ki67+ and ICOS+ T cells were observed on day 8 posttreatment compared to pretherapy per the flow cytometry analyses from 35 pts. Conclusion(s): Lorigerlimab demonstrates a manageable safety profile with evidence of encouraging and durable antitumor activity in a chemotherapy refractory mCRPC population. Randomized evaluation of lorigerlimab in mCRPC is warranted.
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Over the course of a clinical trial, changes in the practice environment have the potential to reduce internal and external validity and impact change in patient outcomes. Such ''history effects''1 can take the form of changes in standard of care, clinical guidelines and recommendations, new drug/device availability in the marketplace, testing and screening procedures, and, as recently experienced, a global pandemic. Clinical trials conducted over many years are particularly susceptible to history effects. Such effects can impact foundational ability to continue a trial, including clinician equipoise and ability to implement trial interventions, necessitating awareness and action planning. For example, Curtis et al.2 acknowledged challenges with clinical guideline history effects and issued recommendations for addressing them such as consideration of participant wellbeing, stakeholder engagement, safety monitoring, review of guideline and policy changes, and development of rules for protocol changes. This session will explore how four multisite clinical trials conducted with VA Cooperative Studies Program sponsorship and coordination have weathered history effects during prolonged periods of enrollment. Topics to be covered include the implementation of pragmatic designs, monitoring of clinical guidelines, assessing control group treatment conditions, modifying protocols, adjusting quality assurance procedures, refining recruitment pathways, and training site investigators. The speakers, Study Chairs, will describe best practices and provide recommendations for navigating history effects in prolonged multisite clinical trials that can ensure outcomes remain relevant and compelling to inform public health at trial commencement. The CSP 2008/PTXRx study is a pragmatic, randomized, double-blind, placebo-controlled, multicenter clinical trial of Veteran patients with diabetic kidney disease (DKD) examining whether pentoxifylline (PTX), when added to usual care, can delay time to end-stage renal disease or death. Enrollment for the study began in 2019, and it is anticipated that 9 years of follow-up will be required to observe the required number of primary events. Given the long duration of the study, changes in clinical guidelines were anticipated and have occurred, including the approval of new DKD therapies and introduction of a new formula for estimated glomerular filtration rate (eGFR) calculation. In anticipation of these changes, the study design allows for whatever standard of care is extant at any time during the course of the study. PTXR's pragmatic trial design and protocol leverage the VA's research infrastructure and remote platforms allowing the study to be responsive to external changes and to safely continue during a global pandemic. The CSP 596/OPTION study is a randomized, double- blind, multicenter trial of Veteran patients with a first or second recurrent Clostridium difficile infection (CDI) comparing (1) fidaxomicin and (2) vancomycin, followed by a taper and pulse to (3) a standard vancomycin regimen. Since enrollment began in 2016, significant changes in CDI epidemiology and clinical management have impacted the study. The COVID-19 pandemic also resulted in an administrative hold on all trial activity followed by staggered reopening of sites due to variable COVID-19 activity and clinical priorities. Many clinical laboratories switched to algorithms that included free toxin assays in addition to polymerase chain reaction (PCR) tests out of concern for overdiagnosis based on PCR testing alone, reducing the number of potentially enrollable cases. There has been increased empirical vancomycin treatment for recurrent CDI without confirmation by stool testing, a requirement for enrollment, and a recruitment strategy for identifying potential cases. Finally, conflicting clinical guidelines for recurrent CDI has created potential equipoise when considering enrollment. Ongoing educational efforts have been made to clarify the protocol and emphasize the validity of the research question as well as protoco changes to allow safe enrollment and follow-up of participants in the face of the ongoing COVID-19 pandemic. The CSP 2005/VALOR is a phase III randomized, open label, multicenter clinical trial of Veteran patients with operable stage I non-small cell lung cancer that compares stereotactic radiotherapy and anatomic pulmonary resection with a primary outcome measure of overall survival. The study was activated in 2017 and recruitment to the trial has been affected by ongoing changes in public and clinician perceptions about stereotactic radiotherapy and surgery that have interfered with equipoise and willingness of participants to enroll. The study team perpetually addresses this challenge through group conversations with local site investigators, study coordinators, and other research personnel to preserve group equipoise across the study. Since the study's activation, new safety information about stereotactic radiotherapy has emerged necessitating protocol modifications while aiming to preserve internal and external validity. The includes modifying standard operating procedures for the study's centralized quality assurance program that has had to adapt its process to remain contemporary. STARPORT, funded by VA CSRD with CSP collaboration, is a randomized, open label, multicenter clinical trial of Veteran patients with oligorecurrent prostate cancer comparing the effects of standard systemic therapy (SST) alone or with PET-directed local therapy using surgery or radiation. Although enrollment was initiated in 2021, changes are already evident in clinical practice guidelines regarding the use of imaging in workup in this patient population. Shortly before the start of accrual, 18F-DCFPyL PSMA PET/CT received FDA-approval. Consequently, it is being rapidly adopted at the STARPORT VA medical centers and the use of conventional imaging using CT or bone scan prior to PET/CT imaging-part of the original eligibility criteria-quickly is falling out of favor. Furthermore, shortly after the start of enrollment, NCCN guidelines adopted the stance that conventional imaging was no longer required in the setting of PSMA PET/CT imaging, solidifying the transition away from conventional imaging. Thus, the protocol is being amended to remove the requirement for conventional imaging as part of workup for oligorecurrence. In addition, to be generalizable, the study is designed to integrate future PSMA radiotracers that are incorporated into practice as well as changes in SST regimens over the time of the study.
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Background: Inflammatory Bowel Disease (IBD) in the elderly (>60yrs) is becoming more prevalent in concordance with the ageing population and the rising incidence of IBD. An increasing number of patients are receiving a diagnosis of IBD in later years in addition to those with known IBD transitioning to elderly. The presentation, disease course, risk of complications and choice of medical therapies differ in this group from younger cohorts. We aimed to examine patient demographics and the incidence of adverse effects/complications amongst elderly IBD patients. We also sought to identify appropriate vaccination rates and uptake with screening services. Method(s): In a single tertiary centre, IBD patients aged >60 attending the outpatient clinic or admitted acutely were invited to complete an anonymous written survey. Result(s): 28 patients surveyed to date. 61% (n=17) had a diagnosis of UC. 54% were female (n=15). Mean age was 67.5, while mean age at diagnosis was 50 (range 19-65). 25% (n=7) received a diagnosis of IBD after 60 years, of which 57% were female. Mean BMI was 25.9. 25% (n=7) reported an infection in the last 6 months, all of whom required treatment with antibiotics. There was only one case of infection requiring hospitilisation, a patient on biologic therapy who developed a clostridium difficile infection. COVID-19 affected 39% (n=11), none required hospitilisation. 21% (n=6) report 2 or more comorbidities, of which 50% report a recent infection requiring treatment. All patients who required IBD surgery (n=5) had a high BMI. 57% (n=16) had a smoking history, with 14% (n=4) being active smokers. Infliximab and salofalk granules were the most prescribed IBD treatments. 46% were on biologics (n=13), with anti-TNF being the most common (29%). 25% (n=7) reported steroid use in the last year while 14% were not currently on IBD treatment. 21.4% (n=6) reported prior malignancy, skin cancer being most common. 50% of cancer sufferers were smokers. 100% have had a minimal of two COVID-19 vaccines. 64% (n=18) have had a flu-vaccine in the last 12 months with 75% (n=21) report annual flu-vaccine uptake. 61% (n=17) had the pneumococcal vaccine. Bowel screening participation was 46.5% (n=13). Conclusion(s): Smoking, high BMI and multiple comorbidities were common in elderly IBD patients. Infections were common in this cohort and typically required treatment with antibiotics, however, were rarely severe or required hospitalisation. Severe infections were seen in those on biologic therapy. Biologics were commonly prescribed to elderly IBD patients. Skin cancer was the most common malignancy. There was suboptimal uptake with vaccinations and bowel screening. (Figure Presented).
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Health care-associated infections (HAIs) are a significant cause of morbidity and mortality in the United States. Common examples include catheter-associated urinary tract infections, central line-associated bloodstream infections, ventilator-associated pneumonia, surgical site infections, and Clostridioides difficile infections. Standardized infection control processes and precautions have been shown to reduce the rate of HAIs, and targeted practices for HAIs have shown further reductions. Patient safety tools have been developed for various HAIs to help guide administrators and are free for public use through the Centers for Disease Control and Prevention STRIVE (States Targeting Reduction in Infections via Engagement) initiative. The Choosing Wisely initiative makes best practice recommendations for physicians to improve quality of care and reduce costs;targeted recommendations were developed to reduce the risk of HAIs. For example, using invasive devices only when indicated and for the shortest time possible reduces the risk of device-related HAIs. The goal of antibiotic stewardship is to reduce C. difficile infections and further development of multidrug-resistant organisms such as vancomycin-resistant Enterococcus and carbapenem-resistant Enterobacteriaceae. Antibiotic stewardship targets physician behaviors such as reviewing antibiotic therapy choices every 48 to 72 hours, reviewing culture results as soon as available, de-escalating antibiotic therapy when appropriate, and documenting the indications for initiating and continuing antibiotic therapy.Copyright © 2022 American Academy of Family Physicians.
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Background: Numerous studies and their meta-analysis have shown a high prevalence of anxiety and depression in patients with inflammatory bowel disease (IBD): Up to a third of patients with anxiety symptoms and a quarter with depression symptoms. These rates increase even more with high disease activity: Up to half of patients with anxiety criteria and up to a third with depression symptoms. Data on the frequency and severity of depression and anxiety in patients with Clostridioides difficile infection (CDI) are not so numerous and unambiguous. During the Covid-19 pandemic, the frequency of depression and anxiety increased among healthy individuals and, even more so, among patients with intestinal diseases. The aim of the study was to evaluate the degree of anxiety and depression in patients with IBD and those with CDI during the Covid-19 pandemic. Method(s): Thirty patients with IBD and 30 patients with CDI were included in the study. IBD was confirmed by endoscopy and histology. CDI was confirmed by enzyme analysis for glutamate dehydrogenase and toxins A and B in the feces of patients with nosocomial infection. Hamilton scale (17 items) was used in order to assess the depression grade. This scale divides patients into four groups: No depression, mild, moderate and severe depression. Anxiety was diagnosed by the Spielberger scale (40 items) which includes analysis of State anxiety (SA) and Trait anxiety (TA). Result(s): Depression was determined in 56.7% of patients in the IBD group: 46.7% had mild depression, and 10% moderate depression. In the CDI group depression was diagnosed significantly more frequently - 86.7% of cases: Mild grade in 76.6% and moderate in 10%, predominantly among women. SA was identified in 46.7% of patients in IBD group, and severe SA in 10.0%. In CDI group the frequency and grade of SA were similar: 40.0% and 13.3% respectively. The of TA was extremely high in both groups: 93.3% in the IBD group, of which 50.0% with severe TA, and 96.7% in the CDI group, of which 40.0% with severe TA. Conclusion(s): The results of the study confirm the presence of anxiety and depression in an extremely large number of patients with IBD and CDI during the Covid-19 pandemic. The frequency of anxiety and depression in this study is significantly higher than previously reported. Patients with IBD and CDI should be monitored for early diagnosis and adequate treatment of depression and anxiety.
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Upper respiratory tract infections are responsible for millions of physician visits in the United States annually. Although viruses cause most acute upper respiratory tract infections, studies show that many infections are unnecessarily treated with antibiotics. Because inappropriate antibiotic use results in adverse events, contributes to antibiotic resistance, and adds unnecessary costs, family physicians must take an evidence-based, judicious approach to the use of antibiotics in patients with upper respiratory tract infections. Antibiotics should not be used for the common cold, influenza, COVID-19, or laryngitis. Evidence supports antibiotic use in most cases of acute otitis media, group A beta-hemolytic streptococcal pharyngitis, and epiglottitis and in a limited percentage of acute rhinosinusitis cases. Several evidence-based strategies have been identified to improve the appropriateness of antibiotic prescribing for acute upper respiratory tract infections.Copyright © 2022 American Academy of Family Physicians.
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Background. Inequities in healthcare among racial and ethnic minorities are globally recognized. The focus has centered on access to healthcare, equitable treatment, and optimizing outcomes. However, there has been relatively little investigation into potential racial and ethnic disparities in HAI. Methods. We performed a retrospective cohort analysis of select HAI prospectively-collected by a network of community hospitals in the southeastern US, including central line-associated bloodstream infection (CLABSI), catheterassociated urinary tract infection (CAUTI), and laboratory-identified Clostridioides difficile infection (CDI). Outcomes were stratified by race/ethnicity as captured in the electronic medical record. We defined the pre-pandemic period from 1/1/2019 to 2/29/2020 and the pandemic period from 3/1/2020 to 6/30/2021. Outcomes were reported by race/ethnicity as a proportion of the total events. Relative rates were compared using Poisson regression. Results. Overall, relatively few facilities consistently collect race/ethnicity information in surveillance databases within this hospital network (< 40%). Among 21 reporting hospitals, a greater proportion of CLABSI occurred in Black patients relative toWhite patients in both study periods (pre-pandemic, 49% vs 38%;during pandemic, 47% vs 31%;respectively, Figure 1a), while a higher proportion of CAUTI and CDI occurred in White patients (Figures 1b-c). Black patients had a 30% higher likelihood of CLABSI than White patients in the pre-COVID period (RR, 1.30;95% CI, 0.83-2.05), which was not statistically significant (Table 1). However, this risk significantly increased to 51% after the start of the pandemic (RR, 1.51;95% CI, 1.02-2.24). Similar trends were not observed in other HAI (Tables 2-3). Conclusion. We found differences in HAI rates by race/ethnicity in a network of community hospitals. Black patients had higher likelihood of CLABSI, and this likelihood increased during the pandemic. Patient safety events, including HAI, may differ across racial and ethnic groups and negatively impact health outcomes. (Figure Presented).
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Background. The COVID-19 pandemic changed accessibility of care and practices within healthcare environments. This period has been associated with healthcare-associated infection outbreaks and shifts in healthcare-associated infectious disease epidemiology. This study's objective is to describe changes in rates and characteristics of antimicrobial-resistant gram negative and Clostridioides difficile (CD) infections during the COVID-19 pandemic in Bernalillo County, New Mexico. Methods. The NM EIP, a collaboration between University of New Mexico and theNMDOH, conducts ongoing laboratory- and population-based surveillance of infectious disease including Clostridium difficile, extended-spectrum beta lactamase (ESBL-E) and carbapenemase-producing gram negative bacteria (CRE). Stata statistical software was used for retrospective analysis of rates and characteristics on NM EIP data from Bernalillo county, NM between 2016 and 2021. Results. Reported C. difficile rates decreased from 76 to 49 cases/month and ESBL-producing Enterobacterales decreased from 145 to 86 cases/month during the pandemic period from March-December 2020 compared with the prior 14 months. Monthly case counts for 2020 are lowest during initial public health orders for the state of New Mexico. Rates of CRE remained constant between 2018-2021. The proportion of CDI cases originating from long-term care facilities decreased significantly from 17.2% to 10.4% (p=0.006) while the proportion attributable to hospital inpatient and community populations remained constant. The proportion of ESBL-E cases from sterile sample sites increased from 3.1% to 4.9% (p=0.05) and the proportion of patients who died within 30 days or prior to discharge increased from 2.2% to 3.2% (p=0.019). Conclusion. Rates and characteristics of CD and ESBL-E infections in Bernalillo countyNMchanged significantly during the COVID-19 pandemic, while rates of CRE remained constant. It is still unclear whether this is related to changes in actual disease rates due to risk factor exposure (healthcare), or if this trend reflects changes in careseeking behavior and/or reporting of cases. (Figure Presented).
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Background. Robust infection control (IC) measures were deployed across healthcare institutions at the start of the COVID-19 pandemic, resulting in increased use of personal protective equipment (PPE), enhanced contact precautions, and emphasis on hand hygiene. The impact of these IC measures on the rates of hospitalacquired infections (HAIs), such as multidrug-resistant organisms (MDROs), device-related infections (DRIs), Clostridium difficile infection (CDI), and respiratory viral infections (RVIs) is not known. Here, we aim to evaluate the effect of the enhanced IC practices on the occurrence of various HAIs in a comprehensive cancer center. Methods. We analyzed the monthly HAIs rates from September 2017 through March 2022, including data 42 months pre-pandemic (September 2016-February 2020) and 24 months during the pandemic (March 2020-August 2021). Reported HAIs were calculated using denominators of patient days for CDI and MDROs, per 1,000 admissions for RVIs, and catheter days for DRIs. The incidence rate ratios (IRR) were calculated for all HAIs. Results. When comparing pre-pandemic to the pandemic period, a significant increase in the overall incidence rate (IR) of MDROs from 0.56 to 0.67 per 1,000 patient days with an IRR of 1.19 (95% CI 1.02-1.39), a decrease in the IR of CLABSIs and a stable IR of CAUTIs and VAEs were observed (Table 1). A significant decrease was observed in the IR of CDI (IRR 0.65 (95% CI 0.55-0.78)). The total IR of hospital-acquired RVIs per 1,000 admissions (5.24 to 1.82;IRR 0.36;95% CI 0.30-0.44) decreased, as did each respiratory virus (Respiratory Syncytial Virus (0.51 to 0.15;IRR 0.30), Influenza (0.50 to 0.24;IRR 0.50), Parainfluenza (1.21- to 0.34;IRR 0.28), Rhinovirus (1.91 to 0.5;IRR 0.26), and Human Metapneumovirus (0.19 to 0.05;IRR 0.24) during their respective respiratory viral seasons (Figure 1). (Table Presented) Conclusion. Implementing strict IC measures during the COVID-19 pandemic in a cancer hospital led to a significant decrease in many HAIs and a reduction in nosocomial RVIs. However, whether these enhanced measures, such as masking at all times as part of patient care, are needed during the upcoming respiratory viral seasons is not known.
ABSTRACT
Background. Antibiotic stewardship programs (ASP) are relatively new in Mexico. It was until May 2018 that it was established as a public health policy in the country. Few hospitals have acknowledged the mandate and started an ASP despite the efforts. Besides, little has been done to evaluate the efficacy of the program in terms of antibiotic expenditure and the incidence of associated infections. Therefore, the main objective was to evaluate antibiotic expenditure before and after the ASP in a third-level hospital in Mexico. As a secondary analysis, the relationship with Clostridioides difficile infections was explored. Methods. This is a retrospective and descriptive study from January 2017 to February 2020 (pre-COVID-19 pandemic). First, the mean antibiotic expenditure (adjusting for DDD/patient days-costs in USD) was evaluated before and after (June 2018 as the first month of implementation) the ASP. Statistical difference of the means was evaluated. It was also performed an exploratory analysis between the prescription of Clindamycin and Levofloxacin with the number of cases and deaths related to C. difficile infection. Results. The average antibiotic expenditure before ASP was US$13,468 +/- 3,267, and US$8,193 +/- 2,574 (p< 0.001) after. Graph 1 presents the changes in trend. Specifically, caspofungin, ciprofloxacin, clindamycin, fluconazole, levofloxacin, linezolid, piperacillin/tazobactam, and tigecycline showed statistically significant reduction after June 2018. Graph 2 displays the descriptive relationship between the prescription of levofloxacin and clindamycin, the cases of C. difficile infection, and the elimination of all associated mortality. Graph 1. Antibiotic expenditure. Before and after AMS Graph 2. Relationship between monthly consumption of clindamycin and levofloxacin and the number of cases/deaths secondary to Clostridioides difficile infections, before and after ASP. Conclusion. The ASP has significantly reduced the antibiotic expenditure in the hospital. Besides reducing the prescription of associated antibiotics, a possible reduction in C. difficile infections and associated deaths were observed.
ABSTRACT
Background. Timely diagnosis and use of contact precautions for Clostridioides difficile infection (CDI) is key to prevent spread in hospital settings. Empowering nursing staff to order stool tests and proactively implement precautions has been shown to reduce hospital acquired CDI. Our institution established a nurse driven CDI order set in 2019, however only 1% of tests were ordered by nurses in the past year. The goal of this quality improvement project was to understand current use of the nurse-driven CDI order set using a novel humble inquiry approach. Methods. We used humble inquiry, an interview approach that poses questions while building relationships with participants through humility, curiosity, and active listening skills to explore barriers to utilization of a nurse driven CDI order set. Two nursing students at a 182-bed Veterans Health Administration (VA) hospital were trained to use humble inquiry and a three-item interview guide. A convenience sample of nurses and nursing assistants were interviewed about a) what they know about the nurse driven CDI order set, b) where there is documentation about the order set and c) barriers to use of the order set (if any). Interviews were conducted from January to April 2022. Demographics were analyzed descriptively. Interview data and the experience of conducting humble inquiry were analyzed using manifest content analysis. Results. Interviews (n=19) with nurses (n=16) and nursing assistants (n=3) revealed the majority (13/19 = 68%) were not aware of the nurse driven CDI order set. Of those aware, most were able to identify the location of information on their unit and where to document in the electronic medical record. The two most common barriers included lack of awareness of the order set and patient reluctance to disclose their bowel habits. Delay in providers reading notes (3/19=16%) and lack of PPE during COVID (1/19= 5%) were also identified as barriers. The nursing students reported the humble inquiry approach allowed participants to be the "experts" and "teachers". Conclusion. The humble inquiry method was valuable in understanding viewpoints and identifying barriers to utilization of a nurse drive CDI order set. Lack of awareness of the order set and patient modesty were identified as barriers and may be targeted for future interventions.
ABSTRACT
Background. Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea and a costly burden on the healthcare system. The COVID-19 pandemic brought enhanced infection control measures that could hypothetically decrease CDI transmission. Nonetheless, diarrhea secondary to COVID-19 and increased usage of broad-spectrum antibiotics could potentially increase testing for or frequency of CDI. We aimed to assess variations in CDI testing and frequency during the first surge of the COVID-19 pandemic in a tertiary community medical center in the Southern United States. Methods. Records from adult patients were retrospectively reviewed at Princeton Baptist Medical Center, Birmingham, AL. Three groups spanning equal time periods were created based on the CDC COVID-19 rate curves for Alabama: PPG (pre-pandemic, 03/01/2020 to 05/31/2020), PG (pandemic, 06/01/2020 to 08/ 31/2020), and SCG (seasonal control, 06/01/2019 to 08/31/2019). We included patients >= 18 years old and excluded readmissions and follow-up visits. We determined the frequency, testing rates, and positivity rates for CDI in each group to assess their differences. Also, we measured the rate of coinfection between C. difficile and SARS-CoV-2. CDI cases were defined as positive toxin enzyme-linked immunosorbent assay (EIA) and glutamate dehydrogenase (GDH), or positivity of either in addition to positive nucleic acid amplification test (NAAT). Differences in frequencies and rates across groups were compared with Fisher exact test. Results. Overall, 7,252 hospitalized patients and 29,671 outpatients were included (Figure 1). No outpatient CDI cases were detected. Outpatient testing rates were: PPG 3 (0.05%), PG 4 (0.05%), and SCG 9 (0.06%). Among inpatients, 3,912 (53.9%) were female with a mean +/- SD age of 61.2 +/- 17.5 years. Overall, CDI frequency, testing rates, and positivity rates did not vary significantly among all groups (Table 1). Among those tested, the only case of C.difficile/SARS-CoV-2 coinfection corresponded to PPG. Conclusion. There were no statistically significant differences in CDI frequency, or positivity rate between the pre-pandemic, pandemic, and seasonal control groups for inpatients. No CDI cases were detected in outpatients. This is likely due to a low testing rate in our population.
ABSTRACT
Background. Despite multiple studies indicating a low prevalence of bacterial coinfection in coronavirus disease 2019 (COVID-19) patients, the majority of hospitalized COVID-19 patients receive one or more antibiotics. Patients with coinfection usually have multiple risk factors and poor clinical outcomes. Methods. A retrospective case control study was conducted comparing clinical characteristics and antimicrobial use in hospitalized adult COVID-19 patients with bacterial co-infections vs. randomly selected patients without co-infections (matched on month of admission). The study was conducted at three hospitals within the Montefiore Medical Center, Bronx, NY between March 1, 2020 and October 31, 2020. A multivariable logistic regression model was developed to assess the relationship of each predictor variable with coinfection status. Secondary outcomes included hospital mortality, antibiotic days of therapy (DOT), and C. difficile infection. Results. A total of 150 patients with coinfection and 150 patients without coinfection were included in the analysis. Table 1 summarized baseline characteristics and risk factors. The multivariable logistic regression model indicated that presence of a central line (OR=5.4, 95% CI: 2.7-11.1), prior antibiotic exposure within 30 days (OR=5.3, 95% CI: 2.8-10.0), prior ICU admission (OR=3.6, 95% CI: 1.7-7.6), steroid use (OR=2.7, 95% CI: 1.4-4.9), and any comorbid condition (OR=2.7, 95% CI: 1.4-5.2) were significantly associated with the development of coinfection (table 2). Mortality was higher in patients with coinfection (56% vs. 11%, p < 0.0001) (table 3). Average antibiotic DOT was 10.5 in coinfected patients compared to 4 in noncoinfected patients, (p < 0.0001). Forty-one percent of coinfected patients had a multidrug resistant organism isolated. C. difficile rate was higher in coinfected patients (4% vs. 0%, p=0.03). Conclusion. As the healthcare community contends with a 3rd year of COVID-19 pandemic, understanding risk factors most predictive of bacterial coinfection can guide empiric antimicrobial therapy and targeted stewardship interventions. Ideally, co-infection risk scores are developed which may be useful for future inpatient surges.