bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and Safety of Investigational Microbiome Drug SER-109 for Treatment of Recurrent Clostridioides difficile Infection
Authors: McGovern Barbara , Sims Mathew , Kraft Colleen , Wang Elaine , Brady Kelly , Ford Christopher , Edward O’Brien , Lombardo Mary-Jane , Wortman Jennifer , Litcofsky Kevin , Mahoney Jennifer , McChalicher Christopher , Winkler Jonathan , Garant Sarah , Aunins John , Henn Matthew , von Moltke Lisa 
Published: November 2021

Background: Antibiotics targeted against Clostridioides difficile bacteria are necessary, but insufficient, to achieve a durable clinical response because they have no effect on C. difficile spores that germinate within a disrupted microbiome. ECOSPOR-III evaluated SER-109, an investigational, biologically derived microbiome therapeutic of purified Firmicute spores for treatment of rCDI. Herein, we present the interim analysis in the ITT population at 8 and 12 weeks. Methods: Adults ≥18 years with rCDI (≥3 episodes in 12 months) were screened at 75 US and CAN sites. CDI was defined as ≥3 unformed stools per day for <48 hours with a positive C. difficile assay. After completion of 10–21 days of vancomycin or fidaxomicin, adults with symptom resolution were randomized 1:1 to SER-109 (4 capsules × 3 days) or matching placebo and stratified by age (≥ or <65 years) and antibiotic received. Primary objectives were safety and efficacy at 8 weeks. Primary efficacy endpoint was rCDI (recurrent toxin+ diarrhea requiring treatment); secondary endpoints included efficacy at 12 weeks after dosing. Results: Overall, 287 participants were screened and 182 were randomized (59.9% female; mean age, 65.5 years). The most common reason for screen failure was a negative C. difficile toxin assay. A significantly lower proportion of SER-109 participants had rCDI after dosing compared to placebo at week 8 (11.1% vs 41.3%, respectively; relative risk [RR], 0.27; 95% confidence interval [CI], 0.15–0.51; p-value <0.001). Efficacy rates were significantly higher with SER-109 vs placebo in both stratified age groups (Figure 1). SER-109 was well-tolerated with a safety profile similar to placebo. The most common treatment-emergent adverse events (TEAEs) were gastrointestinal and were mainly mild to moderate. No serious TEAEs, infections, deaths, or drug discontinuations were deemed related to study drug. Conclusions: SER-109, an oral live microbiome therapeutic, achieved high rates of sustained clinical response with a favorable safety profile. By enriching for Firmicute spores, SER-109 achieves high efficacy while mitigating risk of transmitting infectious agents, beyond donor screening alone. SER-109 represents a major paradigm shift in the clinical management of patients with recurrent CDI. Clinicaltrials.gov Identifier NCT03183128. These data were previously presented as a late breaker at American College of Gastroenterology 2020.Funding: Seres TherapeuticsDisclosures: None
COVID-19 Vaccine Readiness Among Acute-Care Registered Nurses in New Jersey: Results of a Statewide Survey
Authors: Pogorzelska-Maziarz Monika , Lou Manning Mary , Gerolamo Angela , Johansen Mary , Grafova Irina , Crincoli Suzie , de Cordova Pamela 
Published: November 2021

Background: The coronavirus disease 2019 (COVID-19) vaccine is an important intervention to control the COVID-19 pandemic. As the most trusted profession integral to providing care to patients across all care settings, nurses play a critical role in educating patients regarding the SARS-CoV-2 vaccine. However, little is known about the readiness of registered nurses (RNs) to receive the vaccine. Methods: In October 2020, prior to FDA approval of vaccines, we conducted a cross-sectional electronic survey of all active registered nurses in the state of New Jersey. The eligibility criteria included providing direct patient care in a New Jersey hospital in an emergency or an adult inpatient unit during the emergence of COVID-19 (March 2020). Results: In total, 3,027 RNs completed the survey (15% response rate). When asked whether they plan to get vaccinated, 27% of RNs responded yes, 30% responded no, and 43% were undecided. Among those RNs who reported that they were planning to get vaccinated, their main reasons for their willingness to receive the vaccine included (1) wanting to protect themselves and their families (95%), (2) wanting to protect the community at large (76%), wanting to protect their patients (75%), the belief that life won’t get back to normal until most people are vaccinated (72%), and the belief that getting vaccinated is the best way to avoid getting seriously ill from COVID-19 (67%). The main reasons reported for not planning to or being undecided about getting vaccinated included the belief that the vaccine will likely be developed too quickly to be safe (81%) and concern about the side effects from the vaccine (74%). RNs also reported being in a low-risk group for becoming seriously ill (12%) and having had COVID-19 (8%) as reasons for planning not to get vaccinated. In open-ended responses, participants also discussed several additional issues driving vaccine hesitancy: their lack of trust in the political process, planning to become pregnant or currently pregnant or breastfeeding, questions about effectiveness of the vaccine and long-term side effects, and the need for more information before making a decision. Conclusions: This cross-sectional study of all acute-care RNs in the State of New Jersey was conducted prior to the FDA approval of COVID-19 vaccines. The results outline factors driving vaccine hesitancy among RNs. Although vaccine efficacy data and approval by the FDA may have alleviated some of these fears, immunization programs for healthcare workers and the public should focus on dispelling myths about vaccine development and side effects.Funding: NoDisclosures: None
Medical Tape Contamination Study: Effect of Packaging on the Reduction of Cross Contamination
Authors: Vang Kheng , Smith Graham , Pastoor Sara J 
Published: November 2021

Background: Medical tape is used routinely for a variety of tasks across healthcare settings. The literature contains numerous publications in which common practices around medical tapes have been suspected to lead to infection transmission. Healthcare providers can turn to individually packaged single-patient-use medical tape rolls to help reduce cross-contamination risk by limiting exposure to environmental contaminants, minimizing contact with hospital surfaces and equipment, and minimizing exposure to healthcare workers’ hands and other patients. Methods: We evaluated the effect of individually packaged tape on cross contamination using a controlled laboratory assay. Ceramic tiles were inoculated with microorganisms evenly spread across the surface and allowed to air dry. Using gloves, packaged and unpackaged tapes were rolled over their entire outside circumference onto the contaminated tiles to simulate cross contamination. Using new gloves, the packaged tapes were then removed from their package with minimum contact. All cross-contaminated tape rolls were placed in phosphate-buffered water and mixed in a vortexer for bacterial recovery procedures. Serial dilutions were plated on appropriate media for bacterial enumeration. The average log10 colony-forming unit (CFU) recovery was measured for comparison. We used 4 types of tapes in this study (3M Micropore S Surgical Tape, 3M Medipore H Soft Cloth Surgical Tape, 3M Durapore Surgical Tape, and 3M Transpore White Surgical Tape). We used 4 different microorganisms as inoculates: Staphylococcus aureus (methicillin-resistant), Enterococcus faecium (vancomycin-resistant), Klebsiella pneumoniae (carbapenem-resistant), and Clostridium difficile (spore). Each test (tape and bacteria combination) was done in 3 or 6 replicates; each bacterial enumeration was the average of duplicate plates. The detection limit for this method is 8 CFU per sample, which is equivalent to 0.9 log10. Results: The results for all tapes tested showed a statistically significant lower mean log10 recovery of each of the microorganisms tested for packaged versus unpackaged tape (Figure 1). The mean differences of log10 recoveries from a packaged and unpackaged tape ranged from 2.51 log10 (for S. aureus on Micropore S) to 4.64 log10 (for K. pneumoniae on Medipore H). This is equivalent to 99%–99.99% cross-contamination protection from the 4 organisms tested. Conclusions: Individual packaging of medical tape rolls protects them from external contaminants. Even if the packaging becomes contaminated, the tape retrieved from the package will be significantly less contaminated than it would have been from exposure to the same contaminants without packaging.Funding: 3M CompanyDisclosures: None
Cluster of Invasive Pseudomonas aeruginosa Infections in a Neonatal Intensive Care Unit
Authors: Spencer Hillary , Banerjee Ritu , Wilson Gregory , Boswell Tanya 
Published: November 2021

Background:Pseudomonas aeruginosa uncommonly causes illness in neonatal intensive care units (NICU). A cluster of 4 infections was appreciated over 6 weeks in our inborn–delivery NICU, prompting an investigation. Methods: Upon recognition of a cluster of infections, we retrospectively audited all cultures positive for P. aeruginosa from all sites (sterile and nonsterile) over the prior year in the index NICU (NICU 1, inborn) and for comparison in the adjacent NICU (NICU 2, larger, outborn–surgical). We performed multilocus sequence testing (MLST) of available clinical isolates to identify clonality. We initiated quarterly prospective surveillance of P. aeruginosa colonization of infants through nares, perirectal swabs, and tracheal aspirates of intubated infants or oropharyngeal swabs of nonintubated infants. We also swabbed incubators, ventilatory equipment, and sinks for selective P. aeruginosa culturing. Results: We identified 7 invasive P. aeruginosa infections in the inborn NICU (5 bloodstream and 2 pneumonia) over an 11-month period (Figure 1). Over the same period, there were no P. aeruginosa bloodstream infections in the adjacent NICU. Affected neonates were high risk: gestational age ranged from 22 weeks and 4 days to 26 weeks and 3 days; day of life at infection ranged from 6 to 37; 6 infants were on a jet ventilator; and all infants were receiving enteral nutrition (6 of 7 with donor human milk and 7 of 7 with expressed mother’s milk). Two infants died from their infection, and 5 infants survived to hospital discharge. All 7 isolates were pansusceptible to routine antimicrobials. MLST of the first 4 available isolates demonstrated 4 different sequence types; however, the first 2 were from the same clonal complex, indicating relatedness (Figure 1). For environmental samples, 8 obtained 8 cultures (swabs) of incubators and ventilatory equipment, and 24 cultures of faucets and drains of all sinks. Only sink cultures were positive, yielding 3 isolates identified as P. aeruginosa and 4 isolates identified as P. aeruginosa–like. Whole-genome sequencing (WGS) is underway to identify relatedness to the clinical isolates. We initiated quarterly infant surveillance by swab culture for P. aeruginosa nasal colonization then escalated to perirectal and oropharyngeal swab or tracheal aspirate cultures (intubated infants) in subsequent quarters. We did not detect any infants colonized with P. aeruginosa. Conclusions: We identified a cluster of P. aeruginosa in high-risk neonates with no point source. Molecular typing indicated a multiclonal cluster. This finding poses a management dilemma. A colonized water system is suspected and WGS of environmental samples is underway.Funding: NoDisclosures: None
Impact of a Black Physician Panel Discussion on Coronavirus Disease 2019 (COVID-19) Health Education
Authors: Evans Kenisha , Lee-Allen Jannel , Chinemelu Okoye Donald , Uroda Lauren , Chopra Teena , Ikwuezunma Gini , Nnodim Opara Ijeoma , Thompson Hayley 
Published: November 2021

Background: Coronavirus disease 19 (COVID-19) has infected >26 million Americans with >400,000 deaths. Both Pfizer and Moderna vaccines against severe acute respiratory coronavirus 2 (SARS-CoV-2) have demonstrated 95% efficacy; yet there has been growing vaccination hesitancy, especially within communities of color. To achieve herd immunity and quell the spread of SARS-CoV-2, several strategies need to be deployed. This community-based demonstration project highlights the impact of a panel of black physicians’ ability to increase vaccination intent within a social media campaign targeted toward a black audience, namely a live question-and-answer (Q&A) event on SARS-CoV-2 vaccines. Methods: The social media campaign included a flyer featuring the head shots and titles of 11 black physicians. The flyer showcased a live Q&A event via Zoom video conference software. Attendees were requested to preregister with their name, e-mail address, and country of origin. Results: The live Q&A event was attended by 251 viewers. Geographic distribution was predominantly within the United States (~88%), but a few attendees were from the United Kingdom (~11%) and Canada (<1%), Puerto Rico (<1%), and Paraguay (<1%). One hundred twenty eight questions and comments were received from attendees. Audience questions were categorized, with predominant topics as follows: Vaccine Safety, Medical Mistrust, Vaccine Safety in Pregnancy, Vaccine Efficacy, and Vaccine Development. The top five poll results revealed: 31% of audience members were not planning to vaccinate or were not sure about vaccination, but after the event are now planning to vaccinate; 93% believed their knowledge of the C19 vaccines had increased; 95% believed it was important that the information was presented by Black health experts; 90% reported that they trusted the information presented; and 96% rated the session as “good or excellent”. Conclusion: Our social media project is an example of one strategy healthcare professionals can utilize to positively influence local and global communities in the mitigation of the COVID-19 pandemic. Results of this project evaluation showed that viewers responded favorably, reporting increases in vaccine acceptance and knowledge. Most respondents also affirmed the importance of having black experts involved in communicating this information. COVID-19 has disproportionately affected black communities as a result of health inequities and institutionalized racism.1 The event amplifies the importance of utilizing social-media–based interventions and increasing black healthcare representation to aid infection control. 1. Jones C. Why Racism, Not Race, Is a Risk Factor for Dying of COVID-19. Scientific American June 12, 2020.Funding: NoDisclosures: None
Bat Intrusions at a Tertiary Care Center, Iowa 2018–2020
Authors: Alsuhaibani Mohammed , Kobayashi Takaaki , Sheeler Lorinda , Trannel Alexandra , Holley Stephanie , Abosi Oluchi , Jenn Kyle , Meacham Holly , Etienne William , Dains Angie , Kukla Mary , Millard Bill , Marra Alexandre , Wellington Melanie , Diekema Daniel , Salinas Jorge 
Published: November 2021

Background: Bats are recognized as important vectors in disease transmission. Frequently, bats intrude into homes and buildings, increasing the risk to human health. We describe bat intrusions and exposure incidents in our hospital over a 3-year period. Methods: The University of Iowa Hospitals and Clinics (UIHC) is an 811-bed academic medical center in Iowa City, Iowa. Established in 1928, UIHC currently covers 209,031.84 m2 (~2,250,000 ft2) and contains 6 pavilions built between 1928 and 2017. We retrospectively obtained bat intrusion calls from the infection prevention and control program call database at UIHC during 2018–2020. We have also described the event management for intrusions potentially associated with patient exposures. Results: In total, 67 bat intrusions occurred during 2018–2020. The most frequent locations were hallways or lounges 28 (42%), nonclinical office spaces 19 (14%), and stairwells 8 (12%). Most bat intrusions (65%) occurred during the summer and fall (June–November). The number of events were 15 in 2018, 28 in 2019, and 24 in 2020. We observed that the number of intrusions increased with the age of each pavilion (Figure 1). Of 67 intrusions, 2 incidents (3%) were associated with potential exposure to patients. In the first incident, reported in 2019, the bat was captured in a patient care area and released before an investigation of exposures was completed and no rabies testing was available. Also, 10 patients were identified as having had potential exposure to the bat. Among them, 9 patients (90%) received rabies postexposure prophylaxis. In response to this serious event, we provided facility-wide education on our bat control policy, which includes the capture and safe handling of the bat, assessment of potential exposures, and potential need for rabies testing. We also implemented a bat exclusion project focused on the exterior of the oldest hospital buildings. The second event, 1 patient was identified to have potential exposure to the bat. The bat was captured, tested negative for rabies, no further action was needed. Conclusions: Bat intrusions can be an infection prevention and control challenge in facilities with older buildings. Hospitals may need animal intrusion surveillance systems, management protocols, and remediation efforts.Funding: NoDisclosures: None
Laboratory-Confirmed SARS-CoV-2 Following One or More Doses of mRNA Vaccine Among Care Team Members at an Academic Health System
Authors: Curry Scott , Salgado Cassandra , Kuppalli Krutika , Nickerson Patricia , Schrader Morgan , Scheurer Danielle , Hirschhorn Julie 
Published: November 2021

Background: Medical University of South Carolina Health began vaccinating care team members December 15, 2020, with the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine. We report surveillance data for cases diagnosed following vaccination. Methods: Care team members (CTMs) diagnosed with COVID-19 following SARS-CoV-2 vaccination were self-identified during online electronic contact-tracing surveys. Demographic data, symptoms, and dates of symptoms were recorded. CTMs testing positive at MUSC were linked to viral burden data from nasopharyngeal swabs tested on Abbott PCR platforms. Results: As of January 31, 2021, 111 CTMs tested positive for SARS-CoV-2 following vaccination: 99 and 12 after 1 and 2 doses, respectively, at medians of 10 days (range, 1–22) and 5 days (range, 1–16), respectively, from vaccination to testing. Of 2 cases that tested positive >14 days from dose 2, CTMs had symptom onset at 4 and 12 days from dose 2. Among CTMs reporting symptoms, 104 did so after a median of 7 days (mean 6.3, range −23 to +22) from vaccination to symptom onset, with 8 reporting symptoms before vaccination, 9 on the day of vaccination, and 3 CTMs at 1 day after vaccination, 6 CTMs at 2 days after vaccination, and 11 CTMs at 3 days after vaccination. Overall, 86 (78%) of 111 were female and 95 (86%) of 111 were white. The median age was 44 years (range, 22–71). Clinical job roles were most frequently nurses (n = 31, 28%), physicians or physician extenders (n = 19, 17%), and CTMs with no patient contact (n = 21, 19%). Assessment by the contact-tracing team assigned sources as household clusters (n = 22, 23%), local transmission (n = 21, 22%), occupational acquisition from coworkers (n = 11, 12%), travel related (n = 9, 10%), and unknown (n = 32, 34%). Only 32 (32%) CTMs were compliant with physical distancing. Among 104 CTMs reporting symptoms, cough (75%), headache (71%), rhinorrhea (63%), myalgia (60%), sore throat (48%), anosmia (44%), and subjective fever (40%) were the most commonly reported symptoms. Among 54 symptomatic CTMs with available viral-load data, the median and mean cycle numbers (Cn) were 19.98 and 21.91, respectively, for samples tested a median 3 days from symptom onset. Asymptomatic and symptomatic CTMs had a median Cn of 30.1 vs 20.9, respectively (p <0.001) and overall 50% of vaccinated CTMs had Cn >20, with no significant effect seen by vaccine dose (Figure 1). Conclusions: Most COVID-19 cases following vaccination occurred in CTMs with infection incubating prior to vaccination. No significant attenuation of viral load is apparent among vaccinated CTMs with COVID-19, but asymptomatic CTMs diagnosed with COVID-19 following vaccination appear to have resolved infections. Our data reinforce the need to adhere to public health measures by people who have been vaccinated.Funding: NoDisclosures: None
New COVID-19 Transmission after the First Vaccine Dose at Skilled Nursing Facilities in Nebraska
Authors: Kamal-Ahmed Ishrat , Kanishka FNU , Stover Derry , Donahue Matthew , Du Yi , Julian Derek , German Dan 
Published: November 2021

Group Name: DHHS EpiBackground: The inoculation with SARS-CoV-2 vaccine at long-term care facilities (LTCFs) in Nebraska began on December 28, 2020, as part of the Centers for Disease Control and Prevention (CDC) Pharmacy Partnership for Long-Term Care Program.1 As of February 5, 2021, 159 skilled nursing facilities (SNFs) had completed their first vaccine clinic, and 7,271 residents and 6,768 staff had received the first dose of the 2-dose series. Surveillance data before vaccination (December 21–27, 2020) and after the first vaccination dose (January 25–31, 2021) indicate that the weekly SARS-CoV-2 positivity rate at SNFs decreased from 1.18% to 0.42% for residents and 0.54% to 0.11% for staff.2,3,4 In this study, we examined the perceived decrease in new transmission initiated by the first dose of vaccine at SNFs. Methods: We analyzed the data with separate logistic regressions for residents and staff. We included 145 SNFs that completed their first vaccine clinic, and we used the Federal and Pharmacy Partnership database for the number of residents and staff that received the first dose of vaccine at the first vaccine clinic. We followed the SNFs for 21 days after the first vaccine clinic from December 28, 2020, through February 5, 2021, for any first-time SARS-CoV-2–positive cases. The National Healthcare Safety Network (NHSN) database was used to collect the information on the number of residents present at the facility on the day of the first vaccine clinic, if available, or days before in the same week as the first vaccine clinic. The staff count for each facility was extracted from Nebraska Licensure for LTCFs. We collected new case information from the state surveillance, the NHSN, and the Test-Nebraska platform. Results: The mean resident vaccine coverage was 80% and the median staff vaccine coverage was 43%. We found a reverse association between staff vaccine coverage and new positive staff cases. For each percentage increase in staff vaccine coverage, the odds of having a new staff positive case 7 days and 14 days after the first vaccine clinic decrease by 26% and 48%, respectively. No association between coverage and new resident transmission was detected. Possible confounding exists when infected residents might have tested positive 7–14 days after the first vaccine clinic who were not affected by the vaccine. Conclusions: Although we observed the association between lower case count with increased facility-level vaccine coverage, we would need to wait for the administration of the second dose of vaccine before assessing the level of association between coverage and new transmission. Further initiatives are warranted to increase the suboptimal vaccine coverage for staff.Funding: NoDisclosures: None