bluuebunny/crossref_metadata_2025 huggingface dataset:
399. Recent COVID-19 infection is associated with high risk of mortality among patients with Staphylococcus aureus bacteremia
Authors: Eichenberger Emily , Pall Allison , Thomas Stepy , Ray Susan M
Published: November 2023

Background

Staphylococcus aureus bacteremia (SAB) is associated with significant mortality. Recent reports indicate that the incidence of invasive S. aureus infections has increased since the start of the COVID-19 pandemic. The impact of recent COVID-19 infection on clinical outcomes of patients with SAB is unknown.

Methods

We performed a retrospective study investigating outcomes associated with SAB in patients with recent COVID-19 infection (SAB-C) versus patients with SAB without a recent positive COVID-19 test (SAB-N). We used data collected by the Georgia Emerging Infections Program (EIP), a CDC- funded invasive S. aureus surveillance study in the 8-county Atlanta metro area to identify all patients with SAB between 2020-2021. SAB cases were linked to COVID-19 test results from the Georgia Notifiable Disease Reporting data to collect patient COVID-19 test results within 90-days of the initial positive blood culture. For subjects experiencing > 1 episode of SAB, only the first episode was evaluated to ensure independence of observations. Comparisons were made using Kruskal-Wallis test and Fisher’s exact test as appropriate. Statistical significance was set at P=0.05.

Results

Between 2020 -2021 there were a total of 3705 unique patients with SAB. Among them, N=486 (13.1%) had a positive COVID-19 test <90 days prior to SAB (SAB-C), and N=3219 (86.9%) did not (SAB-N) (Table 1). Median time from positive COVID-19 test to first positive blood culture was 7 days. SAB-C had a greater proportion of methicillin resistant S. aureus (MRSA) and hospital onset infection than SAB-N (41.8% vs 36.1%, p=0.0189, and 45.7% vs 17.3%, p< 0.0001 respectively). 7-day mortality and in-hospital mortality were significantly higher among SAB-C vs SAB-N (25.7% vs 9.0%, p< 0.0001, and 43.6% vs 15.3%, p< 0.0001, respectively). Among SAB-C, hospital onset of SAB was significantly associated with mortality (29.6% survivors vs 66.5% non-survivors, p< 0.0001, Table 2).

Conclusion

SAB-C is associated with high mortality. Further research is needed to understand additional factors contributing to this high mortality rate including source of infection, infecting strain, and underlying host immune factors.

Disclosures

All Authors: No reported disclosures
444. The disruptive effects of COVID-19 on the incidence of hospital acquired staphylococcus aureus bacteremia (HA-SAB) and its associated factors with mortality in a tertiary teaching hospital in an upper-middle income country
Authors: Ponnampalavanar Sasheela Sri La Sri , Goh Sheron Sir Loon , Rajandra Arulvani , Suhaimi Nur Alwani , Zainon Siti Norintan , Basri Sazali , Ng Rong Xiang , Yeow Yong Yaw , Kukreja Anjanna
Published: November 2023

Background

Hospital acquired bacteremia is predominantly caused by Staphylococcus aureus. Given its virulence, patients may experience serious complications that can be difficult to diagnose at the time of the infection leading to increased morbidity and mortality. The objective of this study is to evaluate the incidence of hospital-acquired Staphylococcus aureus bacteremia (HA-SAB) and its risk factors associated with mortality among hospitalized patients in Universiti Malaya Medical Centre (UMMC), a tertiary teaching hospital in Malaysia

Methods

This is a retrospective analysis of patients with HA-SAB admitted to UMMC over three time periods (P) in relation to the COVID-19 pandemic; P1 beginning of the pandemic (July 2020-May 2021), P2 during the peak of pandemic (June 2021-June 2022) and P3 recovery phase (July 2022-March 2023). We included patients ≥18 years old who fulfilled the criteria for HA-SAB. HA-SAB was defined as the first positive blood culture performed ≥48 hours after admission in patients with no evidence of infection at the time of admission. HA-SAB rates per 100 days admission and its risk factors associated with mortality were analyzed.

Results

A total of 287 cases of HA-SAB were identified (P1=80, P2=151 and P3=56) and the overall mortality rate was 31%. The HA-SAB rate increased by 42% from 0.19 (P1) to 0.33 (P2) per 100 admission days and decreased to 0.15 per 100 admission days (P3). On multivariate analysis, risk factors associated with mortality among patients with HA-SAB were older age (OR: 1.04, 95% Cl: 1.02-1.06), use of arterial lines (OR: 4.30, 95% Cl:1.57-11.5) and secondary bloodstream infection (BSI) (OR: 0.39, 95% Cl: 0.22 - 0.70).

Conclusion

The COVID-19 pandemic was associated with substantial increase in HA-SAB rate. This was likely due to changes in infection control measures in general and line care prevention bundle specifically to cope with the pandemic such as extended use of personal protective equipment (PPE), and non-adherence to the 5-moments of hand hygiene especially changing gloves between patients. Older age, use of arterial lines and secondary BSI were significantly associated with mortality among patients with HA-SAB.

Disclosures

All Authors: No reported disclosures
450. Performance Evaluation of PMMV as an internal control for the wastewater surveillance of SARS-CoV-2
Authors: Choi Hosoon , Coppin John David , Chatterjee Piyali , Brackens Emma , Mayo Lynn , Hwang Munok , Bennett Morgan , Gamage Shantini D , Jinadatha Chetan
Published: November 2023

Background

SARS-CoV-2 RNA is shed into sewers by infected individuals via excreta and sputum. Detections of SARS-CoV-2 RNA in wastewater can correlate with local COVID-19 prevalence. Wastewater-based surveillance can be a valuable tool for supplementing clinical testing in controlling COVID-19 transmission. Pepper mild mottle virus (PMMV) RNA has been used as a normalization biomarker in wastewater, largely reported for community-level surveillance. Here, we report the abundance of PMMV in wastewater collected during a pilot project of building-level wastewater-based SARS-CoV-2 surveillance and we evaluated the use of PMMV RNA as an internal control.

Methods

Wastewater samples were collected (January 11, 2021, to July 2, 2021) at eight nursing homes located across the US and shipped overnight for processing. After the heat inactivation by incubating samples in a 65±1°C circulating water bath for 90 minutes, the virus in the wastewater was concentrated using InnovaPrep Concentrating Pipette Select, and RNA was isolated from the concentrate and subjected to reverse transcription quantitative PCR (RT-qPCR) and RT-digital PCR to detect SARS-CoV-2 and PMMV RNA.

Steps of building-level wastewater-based SARS-CoV-2 surveillance

Results

Mean copy number and level of variability of PMMV in wastewater were different among the nursing home sites (Figure 1). SARS-CoV-2 was detected in sites with both low and high mean PMMV and variability (Figure 1). The distribution of PMMV for negative, inconclusive, and positives were not different (Figure 2) and no correlation between RNA concertation of SARS-CoV-2 and PMMV in the wastewater was detected (Figure 3).Figure 1.Concentration of PMMV RNA in wastewater of each collection site.Figure 2.Concentration of PMMV RNA in wastewater samples with negative, inconclusive, or positive SARS-CoV-2 detection.Figure 3.Correlation between PMMV RNA and SARS-CoV-2 RNA in wastewater samples.

Conclusion

PMMV RNA has been used to control noise due to varying human waste input. The role of PMMV as an internal control was very limited for this building-level surveillance pilot project. This could be mainly due to very low SARS-CoV-2 viral load in the wastewater samples. In this wastewater surveillance project, the variation of PMMV RNA was too big to be used as normalization factor. Also, the clear cutoff level of PMMV for SARS-CoV-2 detection in the wastewater could not be defined. More controlled studies are needed to determine the usability of PMMV as normalization biomarkers in building level-wastewater SARS-CoV-2 surveillance.

Disclosures

All Authors: No reported disclosures
451. Pre- and Post-implementation Comparison of the Impact of Emergency Department (ED)-Based COVID-19 Point-of-Care Testing on ED Patient Metrics
Authors: Fenstermacher Katherine Z J , Klein Eili , Mumford Jeanne , Maliszewski Barbara , Cole Gai , Saheed Mustapha O , Rothman Richard E
Published: November 2023

Background

Use of Point of Care Testing (POCT) in Emergency Departments (EDs) may afford the opportunity to improve key ED operational metrics. We evaluated the impact of COVID-19 POCT on time to delivery of test results, rates of patients who left the ED with or without a COVID-19 diagnosis, and the amount of time COVID-19-negative patients spent in isolation.

Methods

Retrospective pre-POCT (7/1/2020 – 8/31/2020, N=4105) and post-POCT (1/1/2021 – 3/31/2021, N=4795) implementation analysis of patients presenting to the Johns Hopkins Hospital Adult ED who received symptomatic COVID-19 testing. Both pre- and post-implementation POCT was performed using the Cepheid GeneXpert SARS-CoV-2 or SARS-CoV-2/Flu A/B/RSV nucleic acid tests, which have a run time of 45 minutes; pre-POCT occurred in the hospital central lab and POCT occurred in a POC testing lab established in the ED.

Results

Post-implementation, the time from arrival to test result for all patients decreased by an average of 133.2 ± 3.3 minutes; the time to delivery of test result decreased by 177.4 ± 16.02 minutes for COVID+ patients. Reduction in time to test result was associated with a significant decrease in the percentage of patients who were discharged from the ED without their result being known prior to departure: pre-implementation, 8.7% of all tested patients left without a known result, with 21% of COVID+ patients leaving prior to receiving a diagnosis; post-implementation, only 0.92% of all tested patients and 0.68% of COVID+ patients left the ED without a final COVID diagnosis. The amount of time COVID-19 negative patients spent in isolation in the ED decreased by an average of 129.7 ± 3.3 minutes post-POCT implementation.

Conclusion

Use of ED POCT for COVID-19 in the ED resulted in more rapid time to test results and fewer patients leaving the ED who did not know their COVID-19 status, decreasing the likelihood that a COVID+ patient would unknowingly expose others in the community. Additionally, the improved time-to-test-result reduced the amount of time COVID-negative patients spent in isolation, enabling clinical staff to avoid unnecessary PPE usage and free up negative pressure beds.

Disclosures

Katherine ZJ Fenstermacher, PhD, Cepheid: Grant/Research Support Jeanne Mumford, MT, Cepheid Speaker Bureau: Advisor/Consultant|Cepheid Speaker Bureau: Honoraria Richard E. Rothman, MD, PhD, CEPHEID: Advisor/Consultant|Cepheid: Grant/Research Support|Danaher: Grant/Research Support
466. Immunogenicity of 2nd, 3rd, 4th SARS-CoV-2 Vaccines in Renal Patient Populations
Authors: Chen-Xu Michael , Cooper Daniel , Döffinger Rainer , Jones Rachel , Smith Rona M
Published: November 2023

Background

Dialysis, renal transplant (RTX) and autoimmune kidney disease (AKD) patients are at higher risk of COVD-19 and suboptimal humoral responses post primary SARS-CoV-2 vaccination. As such, these groups have been prioritised for further SARS-CoV-2 vaccine doses. Limited data are available on their immunogenicity.

Methods

Patients on dialysis or with a RTX or AKD who received primary SARS-CoV-2 vaccination were prospectively recruited from three UK sites. SARS-CoV-2 IgG spike antibody (anti-S IgG) and nucleocapsid titres were measured with a Luminex assay post 2nd, 3rd and 4th SARS-CoV-2 vaccines. Endpoints were median anti-S IgG titres and seroconversion (anti-S IgG titre >1896 MFI).

Results

628 patients (58% male, median age 62 years) comprising 240 dialysis, 194 RTX, and 194 AKD patients were recruited, with seroconversion of 96%, 61% and 70% respectively post two vaccines, and median anti-S IgG titres (IQR) of 30604 (24393–31826), 5829 (455–28296) and 18711 (1233–30226). 400/627 (64%) had anti-S IgG titres post 3rd dose (82% BNT162b2, 7% mRNA-1273, 3% ChAdOx1, 8% unknown; median 191 days post 2nd dose), with 27/58 (47%) of RTX and 17/46 (37%) of AKD patient non-responders seroconverting. Seroconversion among RTX and AKD patients overall improved to 78% (114/146) and 79% (122/155) respectively (p< 0.05), but not in dialysis patients post 3rd dose. 212/400 (53%) had serology post 4th dose (66% BNT162b2, 22% mRNA-1273, 12% unknown; median 104 days post 3rd dose), with 10/22 (46%) and 3/25 (12%) of RTX and AKD patient non-responders seroconverting. Anti-S IgG titre and seroconversion were similar within each group post 4th dose (Table 1, Figure 1).

Predictors of non-seroconversion post 3rd dose in a multivariable model were rituximab use within six months, mycophenolate, prednisolone, chronic kidney disease and AKD (all p< 0.05), and post 4th dose, rituximab alone (p< 0.001).

Conclusion

After primary SARS-CoV-2 vaccination, a 3rd but not 4th dose improved anti-S IgG titres and seroconversion in renal patients. Immunosuppressive use, particularly rituximab, was associated with reduced serologic responses (Tables 2, 3). Patients on immunosuppressives should therefore be prioritised for consideration of additional pre-exposure prophylactic agents.

Disclosures

Michael Chen-Xu, MBChB, MRCP, MPH, GSK: Grant/Research Support Rachel Jones, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Roche: Grant/Research Support|Vifor Pharma: Advisor/Consultant Rona M. Smith, MD MRCP, GSK: Grant/Research Support|Union Therapeutics: Grant/Research Support
468. Associations of Socioeconomic Status and Care Access Measures with COVID-19 Testing in Patients with Breast Cancer
Authors: Freeman Jincong Q , Li Xinyi , Lee Yong Gun , Akhiwu Ted O
Published: November 2023

Background

Breast cancer patients (BCpts) are vulnerable to COVID-19 infection and hospitalization. COVID-19 testing and early detection are critical but can be hindered by socioeconomic status (SES) and care access measures (CAM)-related barriers. Little is known about how SES and CAM affect COVID-19 testing in BCpts at the national level.

Methods

We analyzed data collected from stage I-IV BCpts in the 2020 National Cancer Database, a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. Multivariable logistic regression was used to examine the associated SES and CAM with COVID-19 testing.

Results

Of 115,948 BCpts (mean age 61.7 years [SD=13.2]), 75.5% were White, 12.3% Black, 3.8% Asian or Pacific Islander (API), 6.6% Hispanic, and 1.8% American Indian or Alaska Native (AIAN). Overall, 79.3% received a COVID-19 test. Compared with White BCpts, API (adjusted odds ratio [AOR]=1.15, 95% CI=1.05-1.26) or Hispanic (AOR=1.24, 95% CI=1.15-1.34) BCpts were more likely, while AIAN BCpts were less likely (AOR=0.89, 95% CI=0.79-0.99), to be tested. No significant differences in testing were observed between Black and White BCpts (AOR=0.98, 95% CI: 0.93-1.04). Uninsured BCpts were less likely than those insured to receive testing (AOR=0.82, 95% CI=0.72-0.93). BCpts residing in Medicaid non-expansion states had lower odds of testing than those in expansion states (AOR=0.89, 95% CI=0.86-0.92). BCpts with a median household income of < $46,227 (AOR=0.79, 95% CI=0.74-0.83), $46,227-57,856 (AOR=0.82, 95% CI=0.78-0.86) or $57,857-74,062 (AOR=0.82, 95% CI=0.79-0.86) were less likely than those with ≥ $74,063 to get tested. BCpts in urban (AOR=0.81, 95% CI=0.77-0.86) or rural (AOR=0.69, 95% CI=0.61-0.78) areas had lower odds of testing than those in metro areas. Compared with BCpts seeking care at academic/research cancer programs, those at community (AOR=0.71, 95% CI=0.67-0.76) or comprehensive community (AOR=0.79, 95% CI=0.76-0.82) programs were less likely to receive a test.

Conclusion

In this cohort of BCpts, one in 5 were not tested for COVID-19, and they were more likely from a lower SES or to have greater CAM-related barriers. Equitable access to COVID-19 testing is needed to address barriers and better reach this population of BCpts.

Disclosures

All Authors: No reported disclosures
474. Real-World Experience of the Comparative Effectiveness and Safety of Remdesivir and Combination Therapy (Remdesivir and Monoclonal Antibodies) in Immunosuppressed Patients with Mild to Moderate COVID-19: A Retrospective Single-center Study in a Community Setting
Authors: Hirai Jun , Mori Nobuaki , Sakanashi Daisuke , Asai Nobuhiro , Hagihara Mao , Mikamo Hiroshige
Published: November 2023

Background

Although several treatment options have been developed for COVID-19, there are still significant challenges in treating certain immunosuppressed patient populations. The objective of this retrospective observational study was to evaluate and compare the effectiveness and safety of immunosuppressed COVID-19 patients treated with remdesivir alone or combination therapy (remdesivir and monoclonal antibodies).

Methods

We included immunosuppression patients who had at least one risk factor for progression to severe COVID-19 from July 2021 to March 2023. The definition of an immunosuppression patient was follows: an autoimmune disease with immunosuppressive therapy, a kidney transplant with an immunosuppressive agent, or having a solid tumor or blood cancer. REGN-COV2 (casirivimab and imdevimab) was prescribed during the Delta strain epidemic season while sotrovimab was prescribed during the Omicron BA1 strain epidemic season. Treatment for each group was initiated within 7 days of symptom onset. We evaluated the time to the resolution of fever over 24 hours after treatment initiation and the Ct value in the study patients.

Results

We enrolled 86 patients who met the inclusion criteria, of whom 35 received combination therapy (CT group) and 51 received remdesivir alone (MT group). No significant difference was observed between the two groups with regard to laboratory data and underlying diseases. There was no difference regarding the duration of remdesivir administration, non-vaccinated population, and number of vaccination between the two groups. A statistically significant reduction in fever of more than 24 hours was achieved in the CT group compared to the MT group (p = 0.01). The CT group patients showed a steeper viral load reduction with respect to the MT group (p = 0.026). Adverse events such as liver dysfunction and kidney disease occurred in only one patient in each group. On comparing both groups, the duration of hospital stay, the ratio of exacerbation, death by COVID-19, and 30-day all-cause mortality did not differ significantly.

The presentstudy cohort

Conclusion

By evaluating the effectiveness of combination therapy with remdesivir and monoclonal antibodies, our study has the potential to improve clinical outcomes and reduce the burden of COVID-19 in this vulnerable population.

Disclosures

Hiroshige Mikamo, M.D, Ph.D, Asahi Kasei Pharma Corporation: Grant/Research Support|Merck Sharp & Dohme: Honoraria|Pfizer Inc.: Grant/Research Support|Pfizer R&D Japan: Honoraria|Sumitomo Pharma Co., Ltd.: Grant/Research Support|Sumitomo Pharma Co., Ltd.: Honoraria
490. Identifying and Evaluating the Drivers of COVID-19 Vaccine Hesitancy Among Individuals with HIV in New Jersey
Authors: Occhiogrosso Jessica , Rijhwani Leena , Rijhwani Divya , Rajagopalan Aravind , Fox Theresa C , Marone Roseann , Burack Gail , Gaur Sunanda , Bhowmick Tanaya
Published: November 2023

Background

Vaccine hesitancy, defined as the “delay in the acceptance or refusal of vaccines despite availability,” has been a significant challenge to vaccine uptake during the COVID-19 pandemic. Few studies have examined COVID-19 vaccine hesitancy among Americans living with HIV, a population with increased vulnerability to severe infection.

Methods

We conducted a cross-sectional phone survey of 69 adults diagnosed with and receiving longitudinal care for HIV across 3 Ryan White HIV/AIDS Program-funded medical facilities in New Jersey. Surveys were administered from July 2022 to February 2023. Questions targeted COVID-19 vaccination status and concerns, factors that influenced vaccination decisions, and HIV stigma. Participant demographics and medical history were retrieved from the Ryan White Program’s CAREWare database. Data was summarized with descriptive statistics and bivariate correlations, and assessed for mean differences between “low” and “high” average vaccine hesitancy.

Results

Among 69 participants, 96% received ≥1 COVID-19 vaccine and 81% received ≥1 booster (Table 1). 87% were motivated to get vaccinated because it was “necessary due to their health status,” and 70% cited the healthcare team as a “very significant” influence on opinions regarding COVID-19 vaccination. 37 of 69 participants reported higher average vaccine hesitancy (avg. rating > 2.5 out of 5) and thought the healthcare system was less likely to protect their privacy (p = 0.029). No significant difference was noted in HIV stigma, CD4 count, or years on ART between more vs. less hesitant groups. Additionally, participants who were strongly inclined to follow vaccine recommendations from their HIV care provider were more likely to believe that vaccination is important for disease prevention and protection (p < 0.001 for both), and more likely to have received a booster (p < 0.001).

Table 3: strength of associations between those who reported to "generally follow" what their doctor or health care provider recommends about vaccines for their health and specific beliefs about vaccination.

Conclusion

While most participants reported some degree of vaccine hesitancy, their level of hesitancy was not linked to disease-specific variables such as CD4 count, viral load, years on ART, or HIV stigma. However, most participants reported following vaccine recommendations from their HIV care provider, underscoring healthcare professionals’ critical role in vaccine education among people living with HIV.

Disclosures

Tanaya Bhowmick, MD, Shinogi: Advisor/Consultant
496. Maternal Participation in Enrollment Interview and Risk of Bias in a Multicenter Pediatric Network Evaluating COVID-19 Vaccine Effectiveness in Infants
Authors: Simeone Regina , Zambrano Laura D , Newhams Margaret M , Halasa Natasha B , Fleming-Dutra Katherine E , Orzel Amber , Wu Michael J , Randolph Adrienne G , Campbell Angela P
Published: November 2023

Background

The Overcoming COVID-19 network uses a case-control design to estimate effectiveness of maternal COVID-19 vaccination on COVID-19 associated hospitalization of infants. Vaccination history is asked in a maternal interview and verified with jurisdictional immunization information systems (IIS). In the absence of an interview, IIS data alone are used. These data may become less complete as the public health emergency ends and COVID-19 vaccines move to the commercial market. Vaccination status may rely more on interviews, potentially biasing VE estimates. We analyzed possible future participation bias.

Methods

Maternal interview participation was assessed for 699 case infants < 6 months hospitalized with COVID-19 and 613 SARS-CoV-2 test-negative control infants < 6 months with COVID-like illness admitted to 29 U.S. hospitals from December 19, 2021–January 31, 2023. To assess recent changes in participation, two Omicron subvariant periods were defined: Period 1 (December 19, 2021–July 18, 2022) and Period 2 (July 19, 2022–January 31, 2023). Interview participation percentages for vaccinated and unvaccinated cases and controls, overall and by subvariant, were used to calculate interview participation bias factors (BF) (Table 1). The BF can be used to adjust observed estimates of VE for potential participation bias.

Results

Overall, vaccination was more frequent among participating case (25%) vs. non-participating case (16%) mothers (Table 2). Vaccination status did not differ by interview participation among controls. Participation was highest in Period 1 (68% in vaccinated cases) and lowest in Period 2 (31% in vaccinated controls) (Table 3). During Period 1, the BF was 1.0, suggesting no participation bias would occur by limiting to interviewed participants. During Period 2, the BF was 1.9. Independent of other possible biases, differences in participation by case/control and vaccination status would be biased by a factor of 1.9, lowering the observed VE.

Conclusion

Participation in the interview differed by case/control and vaccination status during recent Omicron subvariant circulation. Independent of other biases, our results suggest that future estimates of maternal VE could be biased if future estimates of maternal VE include only women who complete an interview.

Disclosures

Regina Simeone, PhD, Pfizer: Stocks/Bonds Natasha B. Halasa, MD, MPH, Merck: Grant/Research Support|Quidell: Grant/Research Support|Quidell: donation of kits|Sanofi: Grant/Research Support|Sanofi: vaccine support
504. Individual and Neighborhood Factors Associated with Failure to Vaccinate Against COVID-19 Among Pregnant Persons
Authors: Zerbo Ousseny , Ray Thomas , Fireman Bruce , Layefsky Evan , Goddard Kristin , Ross Pat , Greenberg Mara , Klein Nicola P
Published: November 2023

Background

Pregnant persons are at increased risk of complication from COVID-19. Vaccine coverage among pregnant persons has been low. The overall goal of this study was to determine whether unvaccinated pregnant persons cluster geographically and to assess individual and neighborhood factors associated with failure to vaccinate.

Methods

The study setting was Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery organization that provides comprehensive care to approximately 4.4 million members. This study included a cohort of pregnant persons who delivered between December 15, 2020 and September 30, 2022. Pregnant persons were considered vaccinated if they received mRNA COVID-19 vaccines any time before or during pregnancy. We used spatial scan statistics to identify geographical clusters of unvaccinated pregnant persons and determined individual and neighborhood factors associated with failure to vaccinate using multivariate logistic regression.

Results

Among 85,852 pregnant persons residing in Northern California, 46.6% were unvaccinated. Spatial analysis identified 5 clusters with high prevalence of unvaccinated pregnant persons. The proportion of unvaccinated ranged from 53% to 62% within clusters compared with 39% outside clusters. In covariate-adjusted analyses, residence in a cluster decreased the odds of vaccination by 1.64 (95% confidence interval (CI): 1.59 - 1.69). The odds of vaccination also decreased with black race (OR=1.45, 95% CI: 1.37 - 1.54), subsidized insurance (OR = 1.32, 95% CI: 1.26 – 1.38) and living in neighborhoods with high proportion of adults with high school education or less. The Odds of vaccination decreased by 1.21 (95% CI: 1.15 – 1.26), 1.36 (95% CI 1.29 – 1.44) and 1.43 (95% CI 1.34 – 153) for pregnant persons living in neighborhoods where the proportion of adults with high school education or less was 20% to < 30%, 30% to < 43% and ≥43%, respectively.

Conclusion

Almost half of pregnant persons, members of Kaiser Permanente in Northern California, were unvaccinated against COVID-19. Unvaccinated pregnant persons clustered geographically and by some sociodemographic factors. Interventions to increase COVID-19 vaccine coverage among pregnant persons are needed, particularly among vulnerable pregnant populations.

Disclosures

Nicola P. Klein, MD, PhD, GlaxoSmithKline: Grant/Research Support|Merck: Grant/Research Support|Pfizer: Grant/Research Support|Sanofi Pasteur: Grant/Research Support
509. A Comparison of Tocilizumab and Baricitinib for Hospitalized Patients with Severe COVID-19
Authors: Aytoda Priyanka , Albrecht Benjamin , Green Sarah B , Harris Gavin , Busch Lindsay M , Sexton Mary Elizabeth , Wiley Zanthia , Rimawi Ramzy H
Published: November 2023

Background

Baricitinib (BARI) and tocilizumab (TOCI) are two FDA-approved immunomodulating agents for the treatment of COVID-19 patients with worsening respiratory status, but early studies suggest no differences in outcomes between the two therapies.

Methods

This is a single-center retrospective analysis of adult patients who received TOCI or BARI for severe COVID-19 from April 2021 to February 2022. Severe COVID-19 was defined as having a National Institute of Allergy and Infectious Disease (NIAID) Ordinal Scale (OS) score of 6 or 7 as described in the Table I. The primary outcome was days to clinical improvement defined as a reduction by ≥ 2 scores on the NIAID OS after the first dose of TOCI or BARI (Day 1) and analyzed using a stratified log-rank test with stratification by the Day 1 NIAID OS score of 6 or 7. Patients who did not show clinical improvement were removed from this analysis. Secondary outcomes include hospital and intensive care unit (ICU) length-of-stay (LOS) and adverse events (AE). Categorical variables were analyzed using Chi-square or Fisher’s exact test, and continuous variables were analyzed using Student’s t-test or Mann-Whitney U test as appropriate.

Results

A total of 258 patients met inclusion criteria (121 BARI; 137 TOCI). Of patients receiving NIV/HFO (n=224) or MV/ECMO (n=34) at baseline, 33.9% and 71% of patients did not show clinical improvement, respectively. The time to clinical improvement did not differ significantly between BARI and TOCI in patients with baseline NIV/HFO (11.9 vs. 12.6 days respectively; p=0.79). A significant difference in days to clinical improvement was observed in MV/ECMO patients who received BARI or TOCI (7.0 vs. 25.7 days respectively; p=0.04). Hospital LOS, ICU LOS, and AE were similar between groups. Mortality rates were higher in patients who had MV/ECMO at baseline compared to those who received NIV/HFO (50% vs 20.1%, p >0.05), but there were no significant differences in mortality between treatment groups.

Conclusion

Days to clinical improvement did not differ between TOCI and BARI. A significant difference in days to clinical improvement was observed in the MV/ECMO group. However, application of this finding to clinical practice in patients with MV/ECMO is limited due to a small subgroup size and low rates of survival.

Disclosures

All Authors: No reported disclosures
537. Safety and Effectiveness of Ensitrelvir for the Treatment of COVID-19 in Japanese Clinical Practice: A Post-marketing Surveillance (Interim Analysis)
Authors: Ogura Eriko , Nakagawa Noriko , Hayashi Noriko , Tsukimura Eri , Takashima Satoru
Published: November 2023

Background

Ensitrelvir fumaric acid (ensitrelvir) is a novel anti-SARS-CoV-2 drug and an inhibitor of SARS-CoV-2 3CL protease. Emergency regulatory approval was obtained in Japan in November 2022. Post-marketing surveillance (PMS) is currently on-going to evaluate safety and effectiveness of ensitrelvir in Japanese real world clinical practice.

Methods

In the PMS, 3000 COVID-19 patients who were administered ensitrelvir for the first time in about 500 Japanese hospitals or clinics are to be enrolled and observed for 28 days after the first administration. Patient demographics, concomitant medications, other therapy for COVID-19, adverse events, and clinical course (body temperature, presence or absence of systemic symptoms, respiratory symptoms, and gastrointestinal symptoms) are to be investigated.

Results

Of the 234 cases collected by March 2023, 226 cases were included in the safety and effectiveness analysis population. Among the 226 cases, the average age was 43.5 years (the median age was 44.0 [12 - 91] years); 24 cases (10.6%) were aged 65 and over; and 115 cases (50.9%) were male. There were 44 cases (19.5%) with high-risk factors for severe illness. The severity of COVID-19 was mild in all cases.

Of the 226 cases in the safety analysis population, 34 events of non-serious adverse drug reactions were reported, and no cases/events of serious adverse drug reactions were reported. The major adverse drug reactions were diarrhea in 9 cases (4.0%), nausea in 4 cases (1.8%), and aggravation of bronchial asthma in 4 cases (1.8%). Two cases (0.9%) were hospitalized, and the reason for hospitalization was exacerbation of COVID-19 in both cases. No death cases were reported. The median time to resolution of fever was 36.0 hours in the standard-risk group (n=136) and 24.0 hours in the high-risk group (n=32). The median time to resolution of all symptoms was 144.0 hours in the standard-risk group (n=182) and 108.0 hours in the high-risk group (n=44).

In this presentation, results of the interim analysis on cases that have been collected by May 2023 will be reported.

Conclusion

Results of the interim analysis suggest that ensitrelvir is well tolerated and effective in patients with or without risk factors.

Disclosures

Eriko Ogura, MD, Shionogi & Co., Ltd.: I am an emplyee of Shionogi & Co., Ltd. Noriko Nakagawa, n/a, Shionogi & Co., Ltd.: I am an employee of Shionogi & Co., Ltd. Noriko Hayashi, n/a, Shionogi & Co., Ltd.: I am an emplyee of Shionogi & Co., Ltd.|Shionogi & Co., Ltd.: I am an emplyee of Shionogi & Co., Ltd. Eri Tsukimura, n/a, Shionogi Pharmacovigilance Center Co., Ltd.: I am an employee of Shionogi Pharmacovigilance Center Co., Ltd. Satoru Takashima, n/a, Shionogi & CO., LTD.: I'm an employee of Shionogi & CO., LTD.
543. Sex Differences in Clinical Presentation and Outcomes of Adults Hospitalized with COVID-19 Pneumonia After Administration of Infliximab, Abatacept or Cenicriviroc: Subgroup Analysis from the ACTIV-1 Master Protocol
Authors: Rauseo Adriana , Der Tatyana , Alicic Radica , Balani Bindu , Morse Caryn , Zakroysky Pearl , Shaw Linda , Atkinson Jane , Powderly William G
Published: November 2023

Background

A growing body of evidence suggests potential sex differences in the clinical outcomes of COVID-19. In this study we evaluated whether sex and baseline clinical variables were associated with treatment effect after receipt of immunomodulators vs placebo in a study population derived from ACTIV-1 IM clinical trial.

Methods

ACTIV-1 IM is a master protocol that evaluated infliximab, abatacept and cenicriviroc in addition to standard of care in adult patients hospitalized with moderate or severe SARS-CoV-2 infection through randomized, double-blind comparisons to shared placebo. We performed a subgroup analysis of the modified intention-to-treat cohort. Primary outcome was association of sex with time-to-recovery at day 28, key secondary outcomes were 28-day mortality and clinical status at day 14.

Results

A total of 1381 participants were included. There was no difference in treatment effect for primary endpoint of time-to-recovery based on sex for infliximab (RRR 1.14, 95% CI 0.95-1.37 for males and RRR 1.09, 95% CI 0.90-1.34 for females with interaction p=0.77), abatacept (RRR 1.14, 95% CI 0.95–1.37 for males and RRR 1.13, 95% CI 0.91-1.40 for females with interaction p=0.93) or cenicriviroc (RRR 0.99, 95% CI 0.79–1.24 for males, RRR 0.98, 95% CI 0.77-1.24 for females, interaction p=0.93) substudies. There was no difference in treatment effect by sex for secondary outcomes for infliximab and abatacept substudies. The cenicriviroc substudy was terminated early for futility and found no difference in treatment effects based on sex for secondary outcomes either.

Conclusion

There was no difference in treatment effect for infliximab, abatacept or cenicriviroc among males vs females. This suggests a more complex interplay of pathogen and host factors deserving further research to identify therapeutic targets for COVID-19.

Disclosures

Radica Alicic, MD, MSc, Boehringer Ingelheim Pharmaceuticals, Inc.: Advisor/Consultant Caryn Morse, MD, Gilead Sciences Inc.: Grant/Research Support|Janssen: Grant/Research Support|Laurent Pharma: Grant/Research Support|Moderna: Grant/Research Support|Ridgeback Bio: Grant/Research Support William G. Powderly, MD, Merck: Advisor/Consultant
550. Effectiveness of Remdesivir for Treatment of COVID-19 in the Outpatient Setting
Authors: Vo Vinny P , Lu Shu , Shah Madiha , Nguyen Hien
Published: November 2023

Background

Remdesivir (REM) was the first FDA-approved treatment for COVID-19. A clinical trial evaluated the effectiveness of REM for the outpatient treatment of COVID-19, showing an 87% lower risk of hospitalization and death when given within the first 7 days of infectious symptoms in confirmed infection. "Real-world" studies evaluating the outpatient use of REM when Omicron was the predominant variant have not been published. We aim to evaluate the use of REM in the outpatient setting (REM-OP) at our institution.

Methods

VA Northern California Health Care System developed an outpatient clinic for the treatment of COVID-19 after FDA approval of REM-OP in January 2022. Patients had to meet institutional criteria for outpatient management of COVID-19 with REM, including a confirmed positive PCR test, lack of supplemental oxygen, risk for severe disease, and reliable transportation. We retrospectively evaluated patients given REM-OP from 1/21/2022 - 413/2022 when Omicron was the predominant variant in our region. Data were obtained using a data query of outpatient REM prescriptions. Subsequently, the administrations of REM were verified and patient variables, including risk factors for progression to severe disease, COVID vaccination, history of previous infection, and subsequent hospitalization or death within 30 days, were collected via manual chart review.

Results

88 patients received REM-OP with a mean age of 70.0 (SD +/- 11.4) with a predominantly male (92%) and white (67%) population. Most patients had received a least one dose of COVID-19 vaccination but 17% were unvaccinated. The most common risk factors for progression to severe disease included age (75% were over age 65), diabetes (45%), hypertension (64.8%), and cardiovascular disease (31.8%). 98% of patients met at least one risk factor for progression to severe disease and 95% completed REM-OP. 93% of patients received REM within 7 days of symptom onset. Of the 88 patients who were treated, 5 patients were admitted within 30 days (2/5 were due to COVID-19 infection), and 2 patients died (1 of which was attributed to COVID-19).

Patient Characteristics

Comparison to PINETREE Clinical Trial

Conclusion

REM-OP during the Omicron surge in our single-center retrospective study had comparable effectiveness to its use in a clinical trial during the Delta surge.

Disclosures

All Authors: No reported disclosures
588. Ceftolozane/Tazobactam Susceptibility of Carbapenem-Resistant Pseudomonas aeruginosa and Carbapenem-Resistant Enterobacterales Isolates in a Tertiary Hospital in Korea
Authors: Kim Kye-Hyung , Moon Seulgi , Ko Mee Kyung , Yi Jongyoun
Published: November 2023

Background

Carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA) are significant nosocomial pathogens that pose significant challenges in treatment due to their multidrug-resistant nature. Ceftolozane/tazobactam (C/T) is a novel antimicrobial agent that has shown promising activity against these pathogens. However, there is limited data

available on its susceptibility against these resistant isolates in Korea. The aim of this study is to determine the in vitro susceptibility of C/T against CRE and CRPA isolates in a tertiary hospital in Korea.

Methods

Blood isolates of CRE and CRPA were collected from a tertiary hospital between September 2017 and September 2022. A carbapenemase test was performed using NG test CARBA-5. For non-carbapenemase-producing CRE and CRPA, the minimum inhibitory concentration of C/T was determined using the Etest and interpreted according to the CLSI breakpoints.

Results

A total of 120 blood isolates, including 55 CRE and 65 CRPA, were analyzed. Carbapenemase-producing isolates were found in 60.0% of CRE and 27.7% of CRPA samples. Among the CRE isolates, KPC (50.9%), NDM (7.3%), and OXA-48-like (1.8%) carbapenemases were identified, while NDM (21.5%), IMP (3.1%), and VIM (3.1%) were found in CRPA isolates. For the non-carbapenemase-producing isolates, the susceptible, intermediate, and resistant rates to C/T were 9.1%, 7.3%, and 23.6%, respectively, for CRE, and 67.7%, 3.1%, and 1.5%, respectively, for CRPA.

Conclusion

This study provides important information on the in vitro susceptibility of C/T against CRE and CRPA isolates in Korea. The findings will help guide empirical antibiotic therapy and improve patient outcomes. Further studies are needed to evaluate the clinical efficacy of C/T against these resistant pathogens in Korea.

Disclosures

All Authors: No reported disclosures
628. A meta-analysis of Tick Paralysis in humans globally
Authors: Matthews Sarah N , Harfouch Chawki
Published: November 2023

Background

Tick paralysis is a neurological disease that causes acute ascending motor paralysis and sparing of sensory function. It is caused by a neurotoxin released from the tick during hematophagy. Due to the rare occurrence of tick paralysis cases and the lack of a surveillance system, literature is limited and the exact number of cases in the world cannot be quantified.

Methods

We conducted a meta-analysis of medical literature documenting 121 tick paralysis cases from 1940 to present day using PubMed. Cases were stratified based upon geographic location, tick species, and clinical manifestations.

Results

The compilation includes 71 cases in North America, 14 cases in Australia, 33 cases in Asia, two cases in South America, and one case in Africa. In North America, 36.62% of cases (n=26) were caused by Dermacentor andersoni and in Australia, 50% of cases (n=7) were caused by Ixodes holocyclus. Dermacentor, Amblyomma, Rhipicephalus, and Hyalomma tick species were the primary culprits in Asia. The ticks involved in the cases in South America and Africa were not identified. Facial palsy was the most commonly reported primary symptom documented in 35 cases, followed by gait ataxia seen in 26 cases. Three cases involved patients with advanced disease causing respiratory depression and cardiopulmonary arrest.Table 1:Tick Paralysis Cases Documented 1940-PresentTable 2:Tick Paralysis Cases Documented 1940-PresentTable 3:Tick Paralysis Cases Documented 1940-Present

Conclusion

This collection of cases illustrates a wider geographic distribution of tick species than previously documented and suggests the evolving climate and urbanization have significant effects on the expansion of their habitable environments and subsequently, human exposure and illness. Additionally, the meta-analysis supports the need for further education regarding this rare type of tick-borne disease for healthcare providers to ensure prompt diagnosis, appropriate treatment, and improved patient outcomes.

Disclosures

All Authors: No reported disclosures
647. Comparative Analysis of Two Sample -to - Answer Nucleic Acid Amplification Assays for the Detection of Respiratory Viral Pathogens from Pediatric Respiratory Specimens
Authors: Sasidharan Anjana , Banerjee Dithi , Hayes Amanda M , Petty Sydnie , Schuster Jennifer E , Goldman Jennifer , Selvarangan Rangaraj
Published: November 2023

Background

Rapid and accurate diagnosis of acute respiratory infection (ARI) in children is crucial for proper patient management, and nucleic acid amplification tests are the gold standard. Nasal swabs are preferred for surveillance studies due to their ease of use, mainly in children. Our study compares the performance of two sample-to-answer (STA) platforms for detecting multiple viruses in self-collected nasal swabs from symptomatic children.

Methods

Between January 2023 and March 2023, self-collected nasal swabs in UTM from children and staff with ARI symptoms were collected as part of an ongoing school-based surveillance study in a large Missouri school district. Samples were tested on the QIAstat-Dx Respiratory SARS-CoV-2 Panel and the fully automated Hologic Panther Fusion system, which can detect a total of 21 respiratory viruses. Percent Agreement analysis was performed to compare the performance of each platform.

Results

Of 200 samples collected, QIAstat detected viruses in 111 samples (55.5%) and Hologic in 115 samples (57.5%). Both assays showed high overall agreement (90%), with a PPA (Positive percentage agreement) of 89%, an NPA (Negative percentage agreement) of 94%. Parainfluenza (PIV) showed 100% PPA and NPA followed by adenovirus (Adv) (PPA: 100%; NPA: 97.9%) and rhinovirus (RV) (PPA: 92% and NPA: 94%). Human metapneumovirus (hMPV) had the lowest PPA (47%) but a high NPA (99%) (Table 1). The median CT values for QIAstat and Hologic were 28.8 (IQR 23.65 - 32.5) and 29.3 (IQR 24.2 – 34.5), respectively. QIAstat missed 19 detections, including hMPV (9, 53%), coronavirus NL63 (4, 16%), and RV (4, 8%), with a corresponding median Ct of 39.1 (IQR 34.5 – 41.2) on Hologic. Hologic missed 12 detections, with RV being the most common target (9, 17%), and a corresponding median Ct of 32.9 (IQR: 30.3-35.5) on QIAstat.

Conclusion

QIAstat and Hologic exhibit comparable performance (overall agreement 90%) for detecting viral respiratory pathogens from self-collected nasal swabs. Viral detections missed by QIAstat assay had low viral loads, while targets missed by Hologic assay had moderate viral load; additional investigation is needed. Our findings suggest that both STA platforms are suitable for diagnosing respiratory viral infections in self-collected nasal swabs in school-setting.

Disclosures

Rangaraj Selvarangan, BVSc, PhD, D(ABMM), FIDSA, FAAM, Abbott: Honoraria|Altona Diagnostics: Grant/Research Support|Baebies Inc: Advisor/Consultant|BioMerieux: Advisor/Consultant|BioMerieux: Grant/Research Support|Bio-Rad: Grant/Research Support|Cepheid: Grant/Research Support|GSK: Advisor/Consultant|Hologic: Grant/Research Support|Lab Simply: Advisor/Consultant|Luminex: Grant/Research Support
654. Changing trends of molecular characteristics and antimicrobial susceptibility of hypervirulent Klebsiella pneumoniae in community-acquired liver abscess before and after COVID-19 outbreak in South Korea
Authors: Hyun Miri , Lee Ji Yeon , Kim Hyun ah
Published: November 2023

Background

Hypervirulent Klebsiella pneumoniae (K. pneumoniae, hvKP) causes invasive infections, usually community-acquired liver abscess. In this study, we aimed to compare the molecular characteristics and antimicrobial susceptibility of hvKP in community-acquired liver abscess over times, especially before and after COVID-19 outbreak.

Methods

This study was performed on K. pneumoniae isolates of community-acquired liver abscess collected from Keimyung University Dongsan Hospital from 2014-2015 and 2020-2021. Clinical and microbiologic data were collected from medical records. Capsular serotypes and virulence factors were identified by polymerase chain reaction using specific primers.

Results

A total 79 patients were analyzed, 39 (49.4%) of 2014-2015 and 40 (50.6%) of 2020-2021. Capsular serotype K1 (61.5% vs. 62.5%) and K2 (25.6% vs. 30.0%) were no significant differences between the two periods. In virulence factors, IutA (82.1% vs. 97.5%) was significantly increased in 2020-2021 compared to 2014-2015 (p=0.028). RmpA (84.6% vs. 90.0%), kfu (61.5% vs. 70.0%), allS (56.4% vs. 67.5%) were showed no significant changes between two periods. Antimicrobial susceptibility of ciprofloxacin (100.0% vs. 95.0%), ceftriaxone (97.4% vs. 89.7%), and imipenem (100.0% vs. 97.5%) were no significant differences between the two periods.Table 1.Molecular characteristics of hypervirulent Klebsiella pneumoniae in community-acquired liver abscess

Conclusion

In liver abscess, the virulence factors showed a tendency to increase during the study period such as IutA, but the limitation is that there were small numbers of isolates included in this study. Further studies with larger number of isolates will be required to findout the changing characteristics of hvKP over times.

Disclosures

All Authors: No reported disclosures