bluuebunny/crossref_metadata_2025 huggingface dataset:
333. How the COVID-19 Pandemic Accelerated Development of our Complex Outpatient Oral Antimicrobial Therapy (COpAT) Program
Authors: Juskowich Joy J , Thompson Jesse M , Sarwari Arif R
Published: November 2023

Background

At our university medical center, we have well established programs for outpatient parenteral antimicrobial therapy (OPAT) and inpatient multidisciplinary antimicrobial infusions for patients with substance use disorder. Complex outpatient oral antimicrobial therapy (COpAT) uses oral (PO) in place of intravenous (IV) antimicrobials. Despite evidence supporting early IV to PO antimicrobial transition for serious infections, COpAT Programs are not widely incorporated in clinical practice. COVID-19 pandemic’s impact on inpatient bed scarcity triggered COpAT’s accelerated implementation at our institution. A Nov 2020 CEO email served as the catalyst and by Aug 2022 an Infectious Diseases (ID) Pharmacist was hired. By Oct 2022, an ID Physician at 0.5 FTE was assigned COpAT Medical Director. We hypothesized IV to PO antimicrobial transition increased as our COpAT Program developed.

Methods

Retrospective cohort study on 380 COpAT patients discharged Jan 2021 to Apr 2023 categorized in 2 groups: Early Discharge: Short course IV antimicrobials < 2 weeks followed by COpAT (n= 115); Traditional: Longer course IV antimicrobials ≥ 2 weeks followed by COpAT (n= 265). Demographic, clinical, and outcomes data were compared.

Results

Proportion of patients in Early Discharge group increased significantly (19 to 47%, p< 0.001) (Image 1). Traditional group had higher rates of injection drug use and bacteremia. While gram positive organisms predominated in both groups, Traditional group had a higher rate of monomicrobial infection (Image 2). Early Discharge group had a greater proportion of oral antimicrobial days (86 vs. 36%, p< 0.05) and shorter length of stay (8 vs. 24 days, p< 0.05) but higher overall and COpAT-related 30-day readmission rates (15 vs. 6 and 7 vs. 2%, p< 0.05). Both groups avoided inpatient hospital days and had high clinical cure rates (Image 3). COpAT Program ROI was 10.9.

Conclusion

COVID-19 pandemic accelerated development and maturation of our COpAT Program supported by 0.5 FTE ID Physician and 1.0 FTE ID Pharmacist. While readmission rates in both groups were low, possible association between shorter length of stay and increased readmission rates needs further evaluation. COpAT Program investment pays for itself in less than 2 months, mainly through inpatient days avoided.

Disclosures

All Authors: No reported disclosures
334. The devil is in the details: Systematic evaluation of antimicrobial allergy at an academic medical center in Japan
Authors: Adachi Katayama Maho , Okamoto Koh , Okamoto Koh , Kawase Kyotaro , Yamaguchi Ryo , Kitaura Satoshi , Ukai Kohei , Miwa Toshiki , Wakimoto Yuji , Oyabu Tatsunori , Jubishi Daisuke , Hashimoto Hideki , Harada Sohei , Okugawa Shu , Tsutsumi Takeya
Published: November 2023

Background

Antimicrobial allergy is common and encountered by healthcare providers. Inaccurate or incomplete information on antimicrobial allergy leads to inappropriate antimicrobial selection. In the electronic health record (EHR), antimicrobial allergy is not only documented as free text but also listed in the EHR allergy section (EHR-AS). However, its quality has not been well studied.

Methods

This was an observational study at an academic medical center in Tokyo, Japan. We included hospitalized patients who received infectious disease consultations from April 2022 to March 2023. Antimicrobial allergy was assessed through structured interview and review of allergies documented free-text in the provider’s note in the EHR (referred to systematic assessment hereafter). We evaluated the potential for de-labeling. We then compared it with the information in the EHR-AS.

Results

A total of 1,179 patients were included. Systematic assessment revealed 148 (148/1179, 13%) patients had allergy histories related to 214 antimicrobials (Table). Of these, 38 patients (38/148, 26%) had a history related to more than one antimicrobial. Beta-lactam antibiotics accounted for 58% (125/214). Of 214 antimicrobials, allergy histories were documented in 70%, 53%, and 41% of notes written by primary team physicians, nurses, and pharmacists, respectively. In total, 71% (152/214) of antimicrobials in 107 patients found through systematic assessment could have been candidates for de-labeling; 21 for direct de-labeling, 19 for supervised oral rechallenge, and 112 for skin testing followed by oral rechallenge. The remaining 62 antimicrobials were deemed not candidates for de-labeling because of their high-risk features. Out of 214 antimicrobials, 126 (59%) were listed in the EHR-AS and the details were NOT described for 50 antimicrobials (50/126, 40%).

Conclusion

While a majority of antimicrobial allergies could have been candidates for de-labeling when evaluated thoroughly, much fewer allergies were listed in the EHR-AS, often without details. Standardizing the evaluation of antimicrobial allergy and entry to the EHR-AS may facilitate selection of appropriate antimicrobials.

Disclosures

Satoshi Kitaura, MD, PhD, FUJIFILM Toyama Chemical Co. Ltd.: S.K., during graduate school studies, conducted antiviral research involving favipiravir, which was provided by FUJIFILM Toyama Chemical Co. Ltd.
335. Factors Associated with Loss to Follow-Up in Outpatient Parenteral Antimicrobial Therapy: A Retrospective Cohort Study
Authors: Kaul Christina M , Haller Matthew , Yang jenny , Solomon Sadie , Khan Maria , Pitts Robert , Phillips Michael
Published: November 2023

Background

Outpatient parenteral antimicrobial therapy (OPAT) has long been utilized to treat infectious conditions in the outpatient setting, particularly for those conditions requiring prolonged courses of antimicrobials. It is well-known that follow-up with Infectious Diseases can reduce hospital readmission. However, factors associated with loss to follow-up are not well-studied. We sought to understand factors associated with an increased risk to loss of follow-up with Infectious Diseases in OPAT patients.

Methods

This was a retrospective cohort study conducted at NYU Langone Health (NYULH). The study was approved and granted a waiver of authorization and informed consent by the NYU IRB. All OPAT episodes for patients at least 18 years of age initiated during admission from January 1, 2017 to December 31, 2020 were screened.

Data were analyzed using SPSS v.28 and Microsoft Office Excel 2019. Descriptive statistics were used. A multivariate logistic regression model was used to examine factors associated with risk of loss to follow-up.

Results

1,846 instances qualifying OPAT courses were identified. 1,528 (82.7%) of patients were recommended for follow-up with ID. 1,110 (72.6%) patients were seen, while 418 patients (27.4%) were not. Of the patients seen by ID, 981 (88.4%) were seen by the physician, and 129 (11.6%) were only seen by the NP. Patients were seen or contacted by the ID physician a median of two times during their follow-up period (IQR 1-3). The median follow-up period for those patients not lost to follow-up was 21 days (IQR 10-36).

The model was adjusted for chronic medical condition, hospital of admission, and follow-up duration. There was a significant association noted between loss to follow-up with ID and discharge to SAR (OR 3.242, p < 0.001) or LTC (OR 5.906, p < 0.001). There was also an association between the use of federal insurance and loss to follow-up (OR 1.493, p = 0.029).

Conclusion

Discharge to SAR and LTC are strongly associated with loss to follow-up with Infectious Diseases. This work underscores the importance of maintaining links to patients discharged to sub-acute healthcare facilities. Transitions of care remain a weakness in healthcare delivery, and must be improved upon in OPAT.

Disclosures

All Authors: No reported disclosures
348. Impact of Substance Use Disorders on Outcomes of Medically Insured Persons Receiving Multiweek Outpatient Parenteral Antimicrobial Therapy
Authors: Rogers Daniel , Chastain Daniel B , Zhao Lingyu , Zhan Duna , Chen Xianyan
Published: November 2023

Background

Catheter complications, misuse, nonadherence, safety, and legal concerns often prohibit persons with a history of substance use disorder (SUD) from receiving outpatient parenteral antimicrobial therapy (OPAT). However, single center studies in the U.S. found similar rates of readmission and adverse events among patients receiving OPAT regardless of SUD history. As such, we compared outcomes and complications between patients with and without a history of SUD who were treated with multiweek OPAT using claims data from multiple years across the U.S.

Methods

We used data from the IBM MarketScan Databases to identify patients who were ≥ 18 years and treated with intravenous vancomycin, daptomycin, nafcillin, oxacillin, or cefazolin for ≥ 7 days after hospital discharge between July 1, 2016 and July 31, 2020. Those with a history of end stage renal disease or Clostridioides difficile infection were excluded. Patients were separated into two cohorts based on a history of SUD using ICD-10-CM diagnosis codes prior to hospital discharge. The rates of adverse events including drug overdose and catheter complications during OPAT, all-cause readmissions within 90 days after completion of OPAT, and infection-related readmissions within 90 days after completing OPAT were compared between groups.

Results

Of 5903 patients included, 18% (n = 1058) had a history of SUD. Those with a history of SUD were younger than individuals without a history of SUD (47 ± 12 vs 53 ± 15 years, P < 0.0001) and there were fewer male patients in the SUD group (52% vs 56%, P = 0.02). Type 2 diabetes mellitus (43% vs 52%, P < 0.0001), arrhythmias (33% vs 31%, P = 0.152), and depression (49% vs 30%, P < 0.0001) were most common among both groups. More patients in the SUD group experienced at least one adverse event during OPAT (8% vs 5%, P = 0.004). All-cause readmissions and infection-related readmissions within 90 days after completion of OPAT were more common among patients with a history of SUD (40% vs 32%, P < 0.0001 and 27% vs 22%, P = 0.02, respectively).

Conclusion

Patients with a history of SUD experienced higher rates of adverse events during OPAT and were more likely to require readmission for any reason, including readmissions due to infection, within 90 days after completion of OPAT.

Disclosures

All Authors: No reported disclosures
381. Effect of Ceftriaxone+sulbactam+disodium EDTA Combination in Treatment of Complicated Urinary Tract Infections Caused by Metallo Beta-lactamase Producing Enterobacterales: An Open Label Randomized Controlled Trial
Authors: Samantaray Subhashree , Kumar Deepak , Bohra Gopal Krishana , Meena Durga Shankar , Agarwal Ashwini , Chaudhary Gautam Ram , Tak Vibhor , Sharma Ankur , Garg M K
Published: November 2023

Background

Ceftriaxone+sulbactam+disodium EDTA (CSE) is a novel antibiotic-adjuvant combination, approved by Drug Controller General of India (DCGI) against Extended Spectrum Beta-lactamase (ESBL) producing Gram-negative bacilli. Though randomized controlled trials (RCTs) have been conducted to prove efficacy of this combination against ESBL producers, there are only few in-vitro and retrospective studies supporting its role in treating Metallo-Beta Lactamase (MBL) producers. We conducted this RCT with an aim to find out the efficacy of CSE combination against the cUTI cases caused by MBL producing Enterobacterales.

Analysis of Primary End-points in Modified Intent-to-Treat Population

Table 1

Methods

Adult patients aged ≥18 years meeting the USFDA criteria of cUTI, were randomized 1:1 to receive either intravenous CSE (1000 mg ceftriaxone/500 mg sulbactam/37 mg disodium EDTA) every 12 hours or best alternative treatment (BAT) as per hospital policy (injectable colistin or polymyxin B with or without meropenem or ceftazidime-avibactam with or without aztreonam). Primary objective was to show noninferiority of CSE to BAT at the test-of-cure (TOC) visit by a margin of 10%.

Results

Of 66 randomized patients with cUTI growing MBL producing Enterobacterales in culture, 24 of 33 and 31 of 33 were treated with CSE and BAT, respectively. From outcome analysis, it was observed that the non-inferiority criteria for CSE to BAT was not met at pre-defined primary endpoints.(Table 1)

Conclusion

Our findings do not support the use of CSE as a carbapenem-sparing treatment for cUTI patients caused by MBL producing Enterobacterales.

Disclosures

All Authors: No reported disclosures
388. Evaluating Rates of Co- and Secondary Infections in Pediatric Patients with COVID-19 Infections in Relation to Antibiotic Prescribing: An Observational Study
Authors: Allen Brian S , Firmani Sarah E , Prokesch Bonnie C
Published: November 2023

Background

All ages have been greatly impacted by the Coronavirus disease 2019 (COVID-19) pandemic. While many patients with COVID-19 are prescribed antibiotics, there is often little microbiologic evidence for concurrent or secondary bacterial infection. Such prescribing practices may lead to increased antimicrobial resistance. The purpose of this study is to evaluate the number of microbiologically confirmed bacterial co- and secondary infections in pediatric patients with COVID-19 and characterize associated antimicrobial use at a large academic medical center.

Methods

An observational, retrospective review of pediatric patients ≤ 18 years admitted to Children’s Medical Center Dallas campus with COVID-19 infections from 5/01/2020 to 9/30/2022 was performed. Basic demographic, epidemiologic, laboratory, and microbiologic data was obtained upon admission and each new antibiotic course. Cultures and microbiologic data were reviewed for relevance. Antibiotic use was characterized based on drug selection, indication, and spectrum.

Results

Using the International Classification of diseases, tenth revision (ICD-10) code for COVID-19 pneumonia (U07.1) identified 229 patients, of which 164 met inclusion criteria. Within the included patient population, a total of 22 microbiologically-proven infections were found. Both co- and secondary infections were rare (8/164 (5%) and 8/164 (5%), respectively) and consisted of various organisms from differing sites (9 pulmonary, 9 bloodstream, 4 urinary tract, 1 Clostridiodes difficile infection). The most frequently identified organism was Staphylococcus aureus, followed by Escherichia coli and Pseudomonas aeruginosa. 102/164 (63%) children received antibiotics ≤ 48 hours of admission. There were 43 additional instances where antibiotics were started > 48 hours after admission.

Conclusion

Both co- and secondary bacterial infections are rare in pediatric patients with COVID-19 pneumonia, but many hospitalized patients are given antibiotics. Antibiotics were continued in the absence of microbiologic data potentially increasing antimicrobial resistance. There is clearly a role for antimicrobial stewardship in pediatric patients with COVID-19 pneumonia.

Disclosures

All Authors: No reported disclosures
402. Multidisciplinary Management Model for Multisystem Inflammatory Syndrome in Children: A Comprehensive Approach for Improved Patient Outcomes
Authors: Gillen Sarah , Knutson Stacie , Strutt Jonathan , Fischer Gwenyth , Sharon Bazak , Boucher Alexander A , Steiner Marie E , Binstadt Bryce A , Marmet Jordan , Sadak Kate
Published: November 2023

Background

In the spring 2020, Multisystem Inflammatory Syndrome in Children (MIS-C) emerged as a serious threat to children. As case definitions and guidelines were being developed, pediatricians worldwide faced the challenge of identifying and managing this novel condition. Here, we describe our institution's approach to management of MIS-C and describe the outcomes of our patient cohort.

Methods

At the University of Minnesota, a team of specialists in infectious diseases, cardiology, hematology, rheumatology, intensive care, hospital medicine, emergency medicine, and primary care was formed to address emerging concerns. The group collaborated to draft clinical guidelines that were shared locally with clinics and emergency rooms [Figure 1]. The team established multidisciplinary rounds (“MIS-C calls“) which were held remotely via Zoom to facilitate acute care coordination and long-term management plans to be discussed among primary providers and specialists.

Figure 1

Results

Between May 2020 and January 2022, thirty-five children were admitted to the University of Minnesota Masonic Children’s Hospital and diagnosed with MIS-C [Figure 2]. Complications included myocarditis, coronary aneurysm, coagulopathy, acute kidney injury, and shock. Seventeen children required PICU admission. All patients received standardized and comprehensive care, including MIS-C calls, while hospitalized and coordinated ambulatory care after discharge. There were no deaths or long-term cardiovascular morbidity noted through longitudinal follow-up.

Figure 2

Demographic, clinical presentation, hospital course, and out-patient follow-up for a cohort of 35 children hospitalized with MIS-C at the University of Minnesota Masonic Children’s Hospital, between May 2020 and January 2022.

Conclusion

Our institution's multidisciplinary MIS-C model involved a collaborative effort among specialists from various disciplines. By designing and implementing clinical guidelines that were locally disseminated, and establishing daily multidisciplinary rounds, we were able to effectively identify MIS-C cases across our region and provide effective management at our hospital and clinics. Outcomes were favorable without mortality or significant morbidity as all patients fully recovered without any serious long-term sequelae. These findings highlight the importance of a multidisciplinary, comprehensive, and coordinated approach that is well communicated throughout clinical settings, in managing rapidly emerging medical crises.

Disclosures

Gwenyth Fischer, MD, Abiomed: Advisor/Consultant Alexander A. Boucher, MD, CSL Behring: Grant/Research Support Marie E. Steiner, MD, Medtronic: Teaching|Octapharma: Advisor/Consultant Bryce A. Binstadt, MD, PhD, Sobi: Grant/Research Support
414. Sex differences in clinical presentation and outcomes amongst hospitalized patients with COVID-19 in Singapore
Authors: Koh Matthew C Y , Ngiam Jinghao Nicholas , Chhabra Srishti , Goh Wilson , Sim Meng Ying , Chew Nicholas W S , Sia Ching-Hui , Cross Gail , Tambyah Paul
Published: November 2023

Background

Sex differences in clinical presentation and outcomes in patients with coronavirus disease 2019 (COVID-19) remain to be clearly defined. We sought to evaluate sex differences in the presentation and outcomes of COVID-19 in our Asian context.

Methods

We retrospectively examined 1781 consecutive patients hospitalised from 2020 to 2021, with polymerase chain reaction confirmed SARS-CoV-2 infection. Patients were divided into males and females. Baseline clinical characteristics, laboratory findings as well as clinical outcomes were compared. Adverse composite clinical outcomes were defined as requiring supplemental oxygenation, intensive care or mortality.

Results

Of the 1781 patients studied, 351 (19.7%) were female. The male predominance in our cohort were due to large outbreaks of COVID-19 in dormitory workers early in the pandemic. Female patients had more medical comorbidities, and were slightly older (46.4±18.3 vs 41.1±13.4 years, p< 0.001). They had a lower serum ferritin level (174.6±336.7 vs 216.7±284.7 µg/L, p=0.027), but no significant difference in the serum C-reactive protein (16.9±29.1 vs 14.4±29.8 mg/dL, p=0.187). Females were more likely to require supplemental oxygenation (7.1% vs 2.7%, p=0.025) and intensive care (4.8% vs 2.7%, p=0.034), but we did not demonstrate a difference in mortality (0.9% vs 0.7%, p=0.728). On multivariable analysis, female gender remained independently associated with adverse composite outcomes (adjusted OR 1.89, 95%CI 1.17-3.04) after adjusted for dormitory exposure and prior vaccination against COVID-19.

Comparing COVID-19 clinical presentation and outcomes in females versus males amongst hospitalised patients from 2020 to 2021

Multivariable analysis showing female gender independently associated with increased odds of adverse clinical outcomes in COVID-19 illness

Conclusion

Female sex may be associated with adverse clinical outcomes in hospitalised patients with COVID-19. Further study is needed to elucidate and investigate the pathophysiological mechanisms behind this observation.

Disclosures

All Authors: No reported disclosures
417. Impact of Post-acute Sequelae of COVID-19 (PASC) on Healthcare Workers (HCW) in NYC Public Hospital in the South Bronx
Authors: Lim Chee Yao , Gutierrez Jorge , Garcia Alberto Romero , Patel Pinal , Johan Kenneth , Duran Israel , Evans Jeffery , Riordan Anna , Singh Inderpreet , Shariff Masood A , Ashraf Rabia , Kasubhai Moiz , Shabarek Nehad , Dimitrov Vihren , Menon Vidya
Published: November 2023

Background

COVID-19 infection is known to cause long-term sequelae with impact on multiple systems. HCW are at increased risk for COVID-19 exposure and infection. The aim of our study was to assess the burden of PASC among HCW in NYC public hospital which was at the epicenter of the pandemic.

Methods

In this single-center, cross-sectional study, HCW with previous COVID-19 infection were administered an anonymous voluntary survey to evaluate PASC, and its impact on their quality of life (QoL) and mental health. We used CDC COVID-19 variant data tracker to identify predominant variants during the infection. Average number of symptoms/signs, severity, and changes in quality of life were analyzed using JASP.

Inclusion Process of Study Population

Results

Out of the 236 subjects, 144 (61%) had PASC, with 78% having 2 or more symptoms/signs with fatigue being the most common (40%) [Fig 2]. Women had significantly more symptoms than men (2.37 vs 1.26, p=0.005). The mean number of symptoms was comparable among age groups. Average numbers of symptoms were significantly higher among patients who were involved in direct patient care vs indirect patient care. Patients who had reinfection had more symptoms than patients without (2.52 vs 1.76, p=0.02). Among the variants of concern, wild and alpha variants were associated with a higher number of symptoms (p=0.01). Cognitive dysfunction and mental illness (depression/anxiety) were observed to be significantly worsened following COVID-19 infection. PASC adversely affected activities of daily living and disrupted lifestyle.

Breakdown of symptoms/signs according to frequency

Subject Baseline Characteristics

Conclusion

Significant burden of PASC was observed in our healthcare community. The short- and long-term consequences of PASC for HCW could severely affect healthcare services and it is crucial to conduct research and allocate resources to mitigate and overcome these issues.

Disclosures

All Authors: No reported disclosures
429. Risk of COVID-19 Related Deaths for SARS-CoV-2 Omicron (B.1.1.529) Compared With Delta (B.1.617.2): A Retrospective Cohort Study
Authors: Paulson Shon , Raju Jomel
Published: November 2023

Background

The study aimed to assess the risk of covid-19 death after infection with omicron BA.1 compared with the delta (B.1.617.2) variant of the SARS-CoV-2 virus in India.

Methods

The retrospective cohort study is conducted in the state of Kerala, India by retrieving data from the COVID-19 database of the Directorate of Health Services (DHS), Government of Kerala. The main outcome measure was covid-19 death as identified from death certification records. The exposure of interest was the SARS-CoV-2 variant identified PCR positive tests taken in the community sampling and analyzed by the state-approved laboratories. Cause-specific Cox proportional hazard regression models (censoring non-covid-19 deaths) were adjusted for sex, age, vaccination status, previous infection, calendar time, ethnicity, and comorbidities. Interactions between variants and sex, age, vaccination status, and comorbidities were also investigated.

Results

A total of 1035143 people aged 18-100 years who tested positive for SARS-CoV-2 under the surveillance program for COVID-19 and had an infection identified as omicron BA.1 or delta variants of SARS-CoV-2 were included in the study. The risk of covid-19 death was 66% lower (95% confidence interval 54% to 75%) for omicron BA.1 compared with delta after adjusting for a wide range of potential confounders. The reduction in the risk of covid-19 death for omicron compared with delta was more pronounced in people aged 18-59 years (number of deaths: delta=46, omicron=11; hazard ratio 0.14, 95% confidence interval 0.07 to 0.27) than in those aged ≥70 years (number of deaths: delta=113, omicron=135; hazard ratio 0.44, 95% confidence interval 0.32 to 0.61, P< 0.0001). No evidence of a difference in risk was found between the variant and the number of comorbidities.

Conclusion

The results support earlier studies showing a reduction in the severity of infection with omicron BA.1 compared with a delta in terms of hospital admission. This study extends the research to also show a reduction in the risk of covid-19 death for the omicron variant compared with the delta variant.

Disclosures

All Authors: No reported disclosures
438. Predicting Severe and Critical COVID-19 in Fully Vaccinated Individuals: a Single Center Retrospective Cohort Study
Authors: Rivera Charles Kevin L , Carascal Mark B , Cristina Perez Ma , Destura Raul V , Henson Karl Evans R
Published: November 2023

Background

The ability to predict severe/critical Coronavirus Diseases 2019 (COVID-19) infection in fully vaccinated individuals is an incompletely defined area of research and a scoring tool is lacking. Most scoring systems are validated against unvaccinated patients making it less clinically applicable in today’s global landscape. Our study validated an existing clinical prediction tool using data from vaccinated individuals, and created a new model that could provide improved prediction accuracy.

Methods

Consecutive adult patients fully vaccinated against COVID-19 and admitted to a tertiary hospital from March 2021 to August 2022 for a breakthrough infection were enrolled. Clinical characteristics, type and number of vaccine doses, and RT-PCR cycle-threshold (CT) values were collected. Primary outcome of interest was development of severe/critical COVID-19. An existing severe/critical COVID-19 prediction tool was validated using study data as a comparator prediction tool. Multivariable logistic regression analysis was performed to create a simpler scoring system to predict COVID-19 severity.

Results

Among 390 adults with COVID-19, 106 (27%) received at least 1 booster dose and 54 (14%) progressed to severe/critical disease. The existing prediction tool had a sensitivity (Sn) of 98.1%, specificity (Sp) of 7.5% and area under the receiver-operator curve (AUROC) of 0.58. Multivariable logistic regression showed that age >75y (OR 2.15; 95% CI 1.04 - 4.47), diabetes mellitus (OR 1.98, 95% CI 1.07-3.67), CT value < 20 (OR 3.48; 95% CI: 1.78 - 6.79), and non-receipt of a booster dose (OR 0.26; 95% CI: 0.11 - 0.64) were independent risk factors for developing severe/critical COVID-19. The final model showed a Sn of 65%, Sp of 68% and AUROC of 0.71.

Conclusion

A simplified scoring tool using 4 variables may help predict progression to severe/critical COVID-19 in fully vaccinated individuals. Although the tool has modest Sn and Sp, it can be used to help triage patients and guide initial therapy. Validation of this tool in larger studies is recommended.

Disclosures

All Authors: No reported disclosures
443. Albumin is a Reliable and Accurate Biomarker for Assessing Clinical Course of Multisystem Inflammatory Syndrome in Children
Authors: Sharon Bazak , Nath Conor
Published: November 2023

Background

In Spring 2020, Multisystem Inflammatory Syndrome in Children (MIS-C) emerged as a life-threatening pediatric complication to COVID-19. It is a complex and novel disease often requiring high levels of intensive care. As case definitions and guidelines are still being developed, it is imperative to identify biomarkers that can accurately assess its clinical course in hospitalized children.

Methods

Utilizing the electronic medical records we retrieved the charts of children who were hospitalized at the University of Minnesota Masonic children’s Hospital for treatment of MIS-C. We reviewed their clinical course including daily monitoring of various inflammatory markers and analyzed the trends of albumin and CRP.

Results

Between May 2020 and January 2022, thirty-six children diagnosed with MIS-C were admitted to the University of Minnesota Masonic children’s Hospital [Figure 1]. Complications included myocarditis, coronary aneurysm, coagulopathy, acute kidney injury, and shock. Seventeen children required PICU stay. All patients had elevated CRP on presentation, and values typically started to decline within 24-48 hours [Figure 2]. However, hypoalbuminemia continued to worsen for 4-5 days after admission, especially for patients requiring intensive care [Figure 3]. Both markers gradually improved for the entire cohort, reflecting the positive outcome our patients demonstrated.

Conclusion

Our study highlights the reliability of CRP and albumin as biomarkers for assessing MIS-C patients. While CRP values showed a wide range and high variability throughout the course of illness, albumin appeared to be more accurate, particularly in critically ill children. We recommend regular monitoring of albumin as an inflammatory marker and suggest frequent follow-up for children with systemic inflammatory disease.

Disclosures

All Authors: No reported disclosures
448. Real World Evaluation of Clinical Outcomes for Short-Duration Remdesivir Therapy in Hospitalized Patients with Mild-Moderate COVID-19
Authors: Williams Kelsey N , Gauthier Timothy P , Baker Stacey W , Cua Jefferson
Published: November 2023

Background

The optimal duration of remdesivir for hospitalized patients with COVID-19 remains unclear. National Institute of Health (NIH) Guidelines recommend a standard duration of 5 days or until hospital discharge. This study aims to compare the outcomes of hospitalized patients who received ≤ 4 days of remdesivir compared to those who received ≥ 5 days.

Methods

This retrospective study was conducted at a 900-bed community hospital from Jan 1 to Dec 31, 2022. Adult patients were included if ≥ 1 dose of remdesivir was received during hospitalization. Patients were excluded if hypoxic at baseline (oxygen saturation ≤ 94% or on supplemental oxygen). The primary outcome was COVID-19-related hospital readmission within 30 days. Secondary outcomes included hospital length of stay, 30-day mortality, and estimated healthcare cost avoidance (total drug cost and days of hospital admission avoided in the ≤ 4 day group).

Results

1,253 unique patients were screened for inclusion. 772 were hypoxic at baseline, leaving 481 patients for analyses: 67 patients (14%) received ≥ 5 days and 406 (86%) received ≤ 4 days. Table 1 shows demographic data and baseline characteristics. COVID-19 related re-admissions within 30 days occurred in 2 (3%) patients in ≥ 5 day group and 6 (1%) in ≤ 4 day group (p=0.6). Median length of stay was 6 days in ≥ 5 day group and 4 days in ≤ 4 day group (p=< 0.0001). All-cause mortality within 30 days was 0 in the ≥ 5 day group and 5 (1%) in the ≤ 4 day group (p=0.61). No deaths were COVID-19 related. Hypoxia was observed during treatment in 25 (37%) in the ≥ 5 day group and 131 (32%) in the ≤ 4 day group (p=0.41); no difference in outcomes was observed between patients who did and did not develop hypoxia. Estimated cost savings in the ≤ 4 day group was $1,635,312.88 total ($426,312.88 in drug expenditure, $1,209,000.00 for 465 days of avoided admission), or $4,027.86 per patient. Outcomes data is available in Table 2.

Conclusion

Remdesivir for a full 5 days is not warranted in all at-risk hospitalized patients with mild-moderate COVID-19. Shorter remdesivir courses were not found to be associated with worse outcomes and had substantially reduced healthcare costs.

Disclosures

Timothy P. Gauthier, PharmD, BCPS, BCIDP, Ferring: Advisor/Consultant|Firstline: Advisor/Consultant|Firstline: Writing|GSK: Advisor/Consultant|LearnAntibiotics.com & IDstewardship.com: Owner|Melinta: Advisor/Consultant|Pattern Biosciences: Advisor/Consultant|Pfizer: Advisor/Consultant
480. Duration of Infectious Virus Shedding by SARS-CoV-2 Omicron Variant among Immunocompromised Patients
Authors: KAMEGAI K O H E I , Iwamoto Noriko , Itoh Naoya , Ishikane Masahiro , Asai Yusuke , Akazawa Nana , Fuwa Noriko , Takasaki Jin , Hojo Masayuki , Hangaishi Akira , Togano Tomiteru , Teruya Katsuji , Kanno Takayuki , Takahashi Kenichiro , Miyamoto Sho , Hirata Yuichiro , Saito Tomoya , Katano Harutaka , Suzuki Tadaki , Ohmagari Norio
Published: November 2023

Background

Immunocompromised patients with coronavirus disease (COVID-19) shed SARS-CoV-2 RNA longer than usual, but the duration of viral shedding and criteria for nosocomial de-isolation in these patients remains unclear.

Methods

A prospective cohort study was performed at two tertiary medical centers in Japan during the Omicron epidemic waves from July 8, 2022, to January 30, 2023. Nasopharyngeal swab samples were serially collected from immunocompromised COVID-19 patients. We included populations with either hematological malignancies, solid tumors, autoimmune diseases, or human immunodeficiency virus infection. Patients were classified as severely or moderately immunocompromised based on the national COVID-19 guidelines in Japan. The relationship among patients' characteristics, immune status, quantitative reverse transcription PCR (qRT-PCR), and duration of infectious virus shedding between the two groups was assessed using Mann-Whitney U and Fisher's exact tests.

Results

Among 41 patients with 163 samples, nine patients and 47 samples were severely immunocompromised, and 32 patients and 116 samples were moderately immunocompromised. The median ages of the two groups were 70 (IQR: 56-71) and 70.5 (IQR: 60.75-75) years, respectively.

In the severely immunocompromised group, 87.2% of the samples (41/47) were PCR-positive, with a median Cq value of 26.1 (IQR: 20.5-30.2), and 36.2% (17/47) were culture-positive. In the moderately immunocompromised group, 75.0% of the samples (87/116) were PCR-positive, with a median Cq value of 21.9 (IQR: 18.4-28.6), and 38.8% (45/116) were culture-positive (Table 1).

Of the 62 culture-positive samples, five (8.1%) were culture-positive from day 20 onwards, all from severely immunocompromised patients (P = 0.001). In moderately immunocompromised patients, none were culture-positive on day 12 or later (Figure 1).

Conclusion

In COVID-19 patients, particularly those severely immunocompromised, the duration of viral shedding should be closely monitored. Further research is needed to establish a safe period for in-hospital de-isolation of immunocompromised patients.

Disclosures

All Authors: No reported disclosures
484. Clinical Description of SARS-CoV-2 Infection in Patients with Primary Antibody Deficiency Who Received Tixagevimab/Cilgavimab Prophylaxis
Authors: Lim Sung Min , Shin Je Hee , Baek Jee Yeon , Lee Ji Young , Kang Ji-Man , Ahn Jong Gyun
Published: November 2023

Background

Patients with primary antibody deficiency are known to be associated with a higher risk of SARS-CoV-2 infection, complications, and mortality. Tixagevimab/Cilgavimab prophylaxis has shown efficacy in reducing hospitalization and mortality. We aim to describe the clinical characteristics and outcomes of COVID-19 cases in primary antibody deficiency patients receiving tixagevimab/cilgavimab prophylaxis in South Korea.

Methods

This is a descriptive analysis of COVID-19 infection in primary antibody deficiency patients at Severance Children's Hospital. From September 2021 to February 2023, we retrospectively collected data, including demographic characteristics, comorbidities, tixagevimab/cilgavimab prophylaxis status, SARS-CoV-2 vaccination, COVID-19 infection, clinical presentation, COVID-19 treatment, oxygen supplement, hospitalization, and clinical outcome.

Results

Thirteen patients (12 with X-linked agammaglobulinemia and 1 with common variable immunodeficiency) were enrolled in this study. Among them, 10 received tixagevimab/cilgavimab prophylaxis, while the remaining 3 did not. Three patients developed breakthrough infection after receiving prophylaxis. Patient 1 (29 years old, male) completed a SARS-CoV-2 booster mRNA vaccination, had no prior COVID-19 infection, and developed COVID-19 infection 104 days after prophylaxis. Patient 2 (33 years old, male) received 2 doses of mRNA vaccine, had no prior infection history, and developed COVID-19 infection 3 days after prophylaxis. Patient 3 (13 years old, male) had no history of previous vaccination, had an infection history before receiving prophylaxis, and developed COVID-19 infection 19 days after prophylaxis. All 3 patients experienced mild symptoms and did not require oxygen therapy or hospitalization. Of the 7 patients who were not infected with COVID-19 after prophylaxis, 6 had a history of COVID-19 infection, and all of them received SARS-CoV-2 mRNA vaccine. The follow-up period after prophylaxis ranged from 198 to 241 days.Table 1.Clinical description of the hypogammaglobulinemia patients who were diagnosed with COVID-19 with or without tixagevimab-cilgavimab prophylaxis

Conclusion

In this study, we observed that 3 out of 10 primary antibody deficiency patients who received tixagevimab/cilgavimab prophylaxis were infected COVID-19 but did not require hospitalization or oxygen supplementation.

Disclosures

All Authors: No reported disclosures
510. Real-world Effectiveness of Sotrovimab for COVID-19: Evidence from United States (US) Administrative Claims Data
Authors: Bell Christopher F , Lokhandwala Tasneem , Gibbons Daniel C , Drysdale Myriam , Wang Jane , Lloyd Emily
Published: November 2023

Background

This study compared outcomes among COVID-19 patients (pts) treated with the monoclonal antibody (mAb) sotrovimab matched to untreated pts.

Methods

Administrative claims (Komodo Health) were used to identify pts (≥ 12 years) diagnosed with COVID-19 (ICD-10: U0.7.1) in an ambulatory setting in the US (26 May 2021–5 April 2022). The sotrovimab cohort included pts meeting sotrovimab’s Emergency Use Authorization (EUA) criteria and receiving sotrovimab ≤ 10 days from diagnosis (index date = day of infusion). The untreated cohort included pts with no evidence of early/prophylaxis mAb or antiviral treatments (index date imputed based on the time distribution between diagnosis and sotrovimab infusion for their matched counterpart from the sotrovimab cohort). Pts were required to be continuously enrolled for ≥ 12 months pre-index and ≥ 29 days post-index (excluding death). Exact matching and propensity-score matching (EM/PSM) methods were used to construct 1:2 matched cohorts of sotrovimab-treated and untreated patients (EM; age [≤ 5 years], diagnosis date [≤ 14 days], state: PSM; gender, payor, region, Quan-Charlson score, EUA criteria, index date, baseline healthcare utilization). Outcomes evaluated in the 29-day post-index period were all-cause hospitalization, all-cause hospitalization and/or mortality, all-cause mortality, intensive care unit (ICU) admission, and maximum level of respiratory support.

Results

A total of 34,160 sotrovimab pts were matched to 68,320 untreated pts (characteristics well balanced: 54 years of age, approximately 40% male, 42% had commercial payor, and approximately 50% indexed in January 2022). The 29-day hospitalization and/or mortality rates were 4.0% (n=1,380 / 34,160) and 5.2% (n=3,566 / 68,320) in the sotrovimab and untreated cohorts, respectively (p < 0.0001). Patients in the sotrovimab cohort had statistically significantly lower rates of all-cause hospitalization, all-cause mortality, ICU admission, and respiratory support as compared with patients in the untreated cohort (Table).

*Obtained from conditional logistic regression models (binary outcomes). All models adjusted for malignancy. ECMO, extracorporeal membrane oxygenation; ICU, intensive care unit

Conclusion

Sotrovimab demonstrated effectiveness in preventing severe outcomes (hospitalization, mortality and respiratory support) as compared with untreated pts during the period in which Delta and early Omicron variants were predominant.

Disclosures

Christopher F. Bell, MS, GSK: Employee|GSK: Stocks/Bonds Tasneem Lokhandwala, PhD, GSK: Funding to conduct study|Vir Biotechnology, Inc: Funding to conduct study Daniel C. Gibbons, PhD, GSK: Employee|GSK: Stocks/Bonds Myriam Drysdale, PhD, GSK: Employee|GSK: Stocks/Bonds Jane Wang, MS, GSK: Funding to conduct study|Vir Biotechnology, Inc: Funding to conduct study Emily Lloyd, MSc, GSK: Employee|GSK: Stocks/Bonds
514. Nirmatrelvir/ritonavir or Molnupiravir for Treatment of Non-hospitalized Patients with COVID-19 at Risk of Disease Progression
Authors: Butt Adeel A , Yan Peng , Shaikh Obaid
Published: November 2023

Background

In randomized controlled trials, Nirmatrelvir/ritonavir (NMV/r) and Molnupiravir (MPV) reduced the risk of severe/fatal COVID-19 disease. Real-world data are limited, particularly studies directly comparing the two agents.

Methods

Using the VA National COVID-19 database, we identified previously uninfected, non-hospitalized individuals with COVID-19 with >1 risk factor for disease progression who were prescribed either NMV/r or MPV within 3 days of a positive test. We used inverse probability of treatment weights (IPTW) to account for providers’ preferences for a specific treatment. Absolute risk difference (ARD) with 95% confidence intervals were determined for those treated with NMV/r vs. MPV. The primary outcome was severe, critical, or fatal disease within 30 days of treatment prescription using the IPTW approach. Analyses were repeated using propensity-score matched groups and 1:1 matched groups.

Cohort construction

Results

Between January 1 and November 30, 2022, 9,172 individuals were eligible for inclusion (6,692 prescribed NMV/r; 2,480 prescribed MPV). The ARD for severe, critical, or fatal disease for NMV/r vs MPV was -0.18 (95% CI -0.45 to 0.09). There was no statistically significant difference in ARD among strata by age, race, sex, comorbidities, or symptoms at baseline. Kaplan-Meier curves did not demonstrate a difference between the two groups (p-value=0.43). Analysis of the propensity-score matched cohort yielded similar results (ARD for NMV/r vs. MPV -0.12, 95% CI -0.71 to 0.47).

Conclusion

We found no significant difference in short term risk of severe, critical or fatal disease in non-hospitalized individuals with COVID-19 at risk of disease progression treated with either NMV/r or MPV.

Disclosures

Adeel A. Butt, MBBS, MS, Gilead Sciences: Grant/Research Support|Merck and Company: Grant/Research Support
520. Polymerized type I collagen as a treatment for COVID-19 in Mexico
Authors: Del Carpio-Orantes Luis , García-Mendez Sergio , Sánchez-Díaz Jesús Salvador , Aguilar-Silva Andrés , Martínez-Rojas Manuel , Jiménez-Flores Oscar Rodrigo , Villalobos-López Luis Roberto , González-Arce América Alejandrina , González-Medel Karem Samantha , Domínguez-Cámara Rubén , Munguía-Sereno Alvaro Efrén , Zamora-Vázquez Violeta Rosalia , Vázquez-Manzano Quiahuitzin Elizabeth , Ortíz-Pérez Diego , Hernández-Martínez Semiramis Itzel , Hernández-Hernández Sara Nohemí , Solís-Sánchez Ishar , Fonseca-Pouchoulen Victor Alejandro , Montano-Montiel Laura Guadalupe , Reich-Sierra Reynaldo
Published: November 2023

Background

In Mexico, Polymerized Type I Collagen (PTIC) has been used as a treatment for patients with moderate to severe COVID-19, who present inflammation, coagulation activation and oxygen requirements, its use being successful both in outpatient and hospital settings, decreasing morbidity and mortality rates. in patients at high risk of complications.

Methods

Descriptive and retrospective study, which analyzes the response to treatment with PTIC throughout the various waves of COVID-19 presented in Mexico, reviewing the inflammation markers and severity indices, as well as the mortality of each group.

Results

250 patients who used PTIC were entered into the study, distributed according to the waves of COVID (2nd wave=35, 3rd wave=65, 4th wave=120 and 5th wave=30), the average age of all the patients was 46 years , being the masculine gender the most prevalent; The main risk factors in this population are: Obesity, Diabetes and Hypertension. Biochemically, all presented lymphocytopenia, mild thrombocytopenia, as well as elevation of inflammatory markers (D-dimer, ferritin, C-reactive protein, neutrophil/lymphocyte index) and high severity scores with data of secondary hypoxemia, highlighting those affected in the 4th wave where the Delta strain predominated. After treatment with PTIC, inflammation and hypoxemia improved significantly, highlighting low mortality rates even during the 4th wave, which was the most aggressive in Mexico and dominated by the Delta-strain. Mortality in each wave was: 2nd wave=2.9%, 3rd wave=3%, 4th wave=6% and 5th wave=0%

Conclusion

PTIC is a good treatment for moderate to severe COVID-19 in patients with a high risk of complications, significantly reducing mortality rates as well as the risks of inflammation and secondary thrombosis.

Disclosures

All Authors: No reported disclosures
525. Comparison of the acceptability and safety of molnupiravir in COVID-19 patients aged over and under 80 years
Authors: Fujita Kohei , Kanai Osamu , Hata Hiroaki , Odagaki Takao , Mio Tadashi
Published: November 2023

Background

Molnupiravir is being widely used as a treatment for coronavirus disease 2019 (COVID-19); however, its acceptability and safety in older patients aged ≥ 80 years in real-world clinical practice is not well understood.

Methods

We conducted a single-centre retrospective study and assessed the outcome of patients with COVID-19 treated with molnupiravir according to the following criteria: (A) discontinuation rate of molnupiravir; (B) type, frequency, and severity of adverse events; (C) all-cause mortality within 30 days of the diagnosis of COVID-19.

Results

Forty-seven patients (46.1%) were aged ≥ 80 years (older patients) and 55 (53.9%) were aged < 80 years (younger patients). There were no significant differences in coexisting diseases and history of vaccination for COVID-19 between older and younger patients. Older patients were significantly more likely to have moderate disease (moderate 1 and 2) according to the Japanese Ministry of Health, Labour and Welfare classification than younger patients. During treatment, 8.5% of older patients and 1.8% of younger patients stopped taking molnupiravir, but the difference was not significant. Adverse events were observed in 39/102 (38.2%) patients. The most common adverse events were diarrhoea (9.8%), exacerbation of coexisting diseases (6.9%), bone marrow suppression (6.9%), liver dysfunction (5.9%), and loss of appetite (4.9%). Most adverse events were minor, ranging from grades 1 to 3. The all-cause mortality rate was 10.8%, and no molnupiravir-related deaths were observed.

Conclusion

Molnupiravir treatment is acceptable and safe in older patients with COVID-19 aged ≥ 80 years.

Disclosures

All Authors: No reported disclosures