bluuebunny/crossref_metadata_2025_split huggingface dataset:
341. Attitudes and Experiences of Individuals Approached to Participate in a Randomised, Placebo-Controlled, Feasibility Study of Encapsulated Faecal Microbiota Transplantation (FMT) for the Eradication of Gastrointestinal (GI) Carriage of Antibiotic Resistant Organisms (ARO): a Nested Qualitative Study
Authors: Merrick Blair , Prossomariti Désirée , Kertanegara Michael , Wyatt David , Goldenberg Simon D 
Published: November 2023

Abstract

Background
We undertook a single-centre, randomised placebo-controlled study to assess feasibility of eradicating GI carriage of ARO using encapsulated, lyophilised FMT – FERARO – IRCTN reg. no. 34467677. To aid design of future substantive trial, a nested qualitative study collected participant experiences and perceptions.

Methods
A subset (n=24) of recruited participants were approached and 13/24 (54%) participated in one of two 2-hour in-person semi-structured focus groups during, or shortly after completion of, their 6-month study follow-up. Additionally, where given, reasons for non-participation in approached eligible individuals were collected (n=110). Qualitative data underwent thematic analysis; initial coding and theme identification were undertaken by 2 trial researchers independently before further analysis in collaboration with third independent qualitative researcher.

Results
Four central themes were identified; (i) barriers to, and (ii) drivers of, trial participation, (iii) participant randomised controlled trial experience, and (iv) support of future research projects. Participation was influenced by physical ability and time availability to complete study related activities, prior treatment journey and experiences, as well as ongoing available treatment options, and altruism - a willingness to give back to the National Health Service (NHS). Importantly, neither the Covid-19 pandemic, nor lack of acceptability (‘yuck’ factor) of encapsulated lyophilised FMT, were identified as barriers to participant recruitment. FMT was well tolerated, and an intervention that participants viewed as ‘natural’ when compared to other medical treatments. Participants reported that both physical and mental health and/ or health behaviours improved as a result of trial participation, regardless of treatment allocation.
Themes, subthemes, and their relationships.

Conclusion
The frequency of face-to-face hospital-based study appointments presented a barrier to study participation, particularly for less mobile, more comorbid patients – a cohort that may benefit the greatest from participation. Substantive trial recruitment may be incentivised by the use of remote and/ or home visits including for investigational medicinal product (IMP) administration.

Disclosures
Simon D. Goldenberg, FRCPath, MD (Res), PGDipID, DipHIC, MSc, EnteroBiotix: Honoraria|Tillotts Pharma UK: Honoraria
342. Evaluation of Patient Satisfaction with Outpatient Parenteral Antibiotic Therapy (OPAT) at a University Medical Center
Authors: Sawey Ciara , Munsiff Sapan A , Burgoyne Colleen 
Published: November 2023

Abstract

Background
With the expansion of OPAT care over recent years, new devices such as elastomeric balls have been added to the available drug delivery options, which also include syringe, electronic pumps and gravity bags. The primary objective of this study was to evaluate the experience of patients (and their caregivers) on OPAT, ease of use with various delivery methods, and barriers to outpatient care.

Methods
The survey included questions on IV antibiotic received, delivery method, who administered the medicines, effect on daily activities, ease of access to staff, and thoughts on various aspects of the process and experience. Questions were multiple choice, based on Likert scale, or open-ended. Patients were recruited in person during infectious diseases (ID) clinic visits, or by phone, just before or around the time OPAT ended.

Results
We had 51 responses from 130 patients from 10/1/22 thru 3/31/23. Median age group was 55-64 years, 45% were women, for 78% it was first OPAT episode, and 23% received &gt; one IV drug. Syringe push was used for 37%, elastomeric ball for 38%, gravity bag for 18% and electronic pump for 7% of agents. Most (76%) received help in administering treatment by friend or family (spouse=75%). 44% of infusions were once/day and 27% were 3 or more times/day. Home nursing services were received by 94% (5 different agencies) and &gt; 6 different infusion pharmacies supplied the medicines. Medicine was always delivered on time for 38 of 45 respondents.
All patients found IV push and elastomeric ball easy to use; 25% disagreed with this about gravity bag or electronic pump. Overall satisfaction was 94% with OPAT course and 94% felt instructions on how to administer medicines at home were clear and easy. Financial hardships were noted by 9 of 48 respondents (12 responded “neutral”) and 77% had to curtail some or most of their daily activities while on OPAT.

Conclusion
Overall, patients’ responses were positive of our OPAT program. However, the large portion of patients needing to curtail their usual activities highlights the need for more study on how regimen details such as delivery device and infusion frequency impact patient and caregiver experience. Financial hardships may be underestimated as final bills may not yet have been received by patients.

Disclosures
All Authors: No reported disclosures
344. Evaluation and Comparison of the Complex Outpatient Oral Antibiotics Therapy (COPAT) Program vs Oral Parenteral Antibiotic Therapy (OPAT) Program at West Virginia University (WVU) Medicine Healthcare System
Authors: Okunlola Ololade O , Pizzuti Vincenzo J , Johnson Jessica , Juskowich Joy J , Sarwari Arif R , Reece Rebecca 
Published: November 2023

Abstract

Background
Patients with severe infections often require several weeks of antibiotic therapy. Outpatient Parenteral Antibiotic Therapy (OPAT) services decrease hospital length of stay, incidence of hospital-associated infections, healthcare costs, and increase patient recovery rates. Complex outpatient oral antibiotics therapy (COPAT) is an alternative to OPAT that transitions patients to appropriate and equally efficacious oral antibiotics. While there is extensive body of literature on OPAT, there is a paucity on COPAT. We aimed to examine the COPAT program at WVU Medicine, particularly patient demographics and clinical outcomes, and compare these to OPAT.

Methods
This was a retrospective chart review of patients enrolled in COPAT and OPAT program between January 2021 to May 2022 at WVU Medicine, excluding patients who switched cohorts. From the electronic health record, both demographic and clinical variables were extracted. Descriptive analyses were done comparing demographics and clinical outcomes of OPAT, COPAT and non-intravenous drug use (IVDU) COPAT patient groups. Inferential analysis is currently underway.

Results
A total of 334 charts were reviewed with 55% in OPAT program and 45% in COPAT. Demographic differences included younger age, higher tobacco and IVDU, and fewer other co-morbidities in COPAT group (Table 1). Separate analysis of non-IVDU COPAT found a similar trend of younger with fewer co-morbidities. The most common infection across groups was septic arthritis, comprising around 13% (OPAT) and 20% (COPAT) of cases. However vertebral osteomyelitis and endocarditis were higher in COPAT cohorts. Outcome findings were increased length of stay in COPAT but reduction in readmission rates compared to OPAT cohort. Increased safety interventions (22%) in OPAT compared to only 7% in COPAT, mostly due to acute kidney injury and myelosuppression. (Table 2)

Demographics and Infection Types Seen in OPAT, COPAT and Non-IVDU COPAT Patients.

Clinical Outcomes and Adverse Events observed in OPAT, COPAT and Non-IVDU COPAT Patient Groups.

Conclusion
This study demonstrated that COPAT is a suitable treatment option for both IVDU and non-IVDU patients with decreased rates of readmission and safety interventions and with lower rates of severe adverse events. While selection bias may explain differences in risk factors between OPAT and COPAT, the large variance in readmission and safety intervention rates suggests a possible causal relationship.

Disclosures
All Authors: No reported disclosures
364. Novel Polygalacturonic and Caprylic Acid (PG+CAP) Antimicrobial Wound Ointment is Effective in Managing Microbially Contaminated Chronic Wounds in a Pilot Prospective Randomized Clinical Study
Authors: Hachem Ray Y , Hakim Christopher , Dagher Hiba , Samaha Roula , Hammoudeh Diya' , Hamerschlak Nelson , Nasr Janane , Rosenblatt Joel , Jiang Ying , Chaftari Anne-Marie , Ghanem Odette , Ibrahim Amir , Bizri Abdul Rahman , Raad Issam I 
Published: November 2023

Abstract

Background
The use of antibiotics and antiseptics in the management of biofilm colonized chronic wounds is not fully effective in eradicating multidrug-resistant organisms. We developed PG+CAP ointment combining naturally derived agents commonly used in skin care and showed in our in vitro study that PG-+CAP combination ointment could rapidly eradicate gram positive, gram negative and fungal organisms embedded in biofilm within 1 hour. Furthermore, in a full thickness, microbially contaminated swine wound model study we found that with daily ointment application, PG+CAP ointment was significantly better at healing wounds at 2 weeks compared to MediHoney and was also significantly better at eradicating microbes colonizing wound tissues. In this current pilot human study, we compared PG+CAP ointment to MediHoney at three international centers.

Methods
This is a multicenter prospective randomized open label comparative study where patients with chronic full-thickness wounds at three academic international medical centers (American University of Beirut and Lebanese American University, Lebanon and Albert Einstein Medical Center, Brazil) were randomized to a daily treatment with either PG+CAP ointment or MediHoney. Clinical and wound assessments were obtained weekly up to 6 weeks. Full improvement was defined as 50% or greater decrease in wound size and/or a 75% or greater re-epithelialization and granulation of the wound with no necrosis or related adverse events (AEs) or sepsis. The validated Pressure Ulcer Scale for Healing (PUSH) score was used to track wound healing.

Results
A total of 20 patients with chronic wounds were included (10 patients in each arm). Age and clinical characteristics were comparable in both groups. Diabetes mellitus tended to occur more frequently in the PG+CAP arm (See Table 1-P=0.06). Full improvement/healing occurred in all patients (100%) randomized to PG+CAP with no AEs vs 70% full improvement in the MediHoney arm. Patients who received PG+CAP had more than two-fold wound improvement in terms of their PUSH scores compared to MediHoney:Table 1.Characteristics & Outcomes

Conclusion
Based on preliminary data from this prospective randomized multicenter trial, PG+CAP is safe and possibly more effective in achieving full improvement of chronic contaminated wounds when compared to MediHoney.

Disclosures
Joel Rosenblatt, PhD, Novel Anti-Infective Technologies, LLC: Licensed Technology Issam I. Raad, Distinguished Professor, Novel Anti-Infective Technologies, LLC: Technology License
372. Co-Administration of OVX836, NP-Based Universal Influenza Vaccine Candidate, with Conventional HA-Based Influenza Vaccine: Results of Phase 2a Clinical trial
Authors: Willems Paul , Tourneur Jessika , Guyon-Gellin Delphine , Le Vert Alexandre , Nicolas Florence 
Published: November 2023

Abstract

Background
Quadrivalent Inactivated Influenza Vaccine (QIV) generate antibody responses mostly directed against the highly mutating hemagglutinin. An alternative path for influenza vaccination is to generate cellular immunity to well-conserved nucleoprotein (NP), which has been associated with protection against influenza disease.
OVX836 is an unadjuvanted recombinant vaccine targeting NP. We have previously shown that OVX836 induces strong, dose-dependent NP-specific T and B-cell immune responses in human, with a signal for efficacy of 84% (95%CI=17%-97%), together with synergistic protection with QIV in preclinical models.
Here, we investigate in human the concomitant administration of OVX836 with QIV.

Methods
Phase 2a, randomized, double-blind, controlled, study to evaluate immunogenicity and safety of the concomitant administration of OVX836 and QIV in healthy adults (18-55 years) as 2 separate injections into the same arm, compared to (i) QIV and (ii) OVX836.

Results
Safety: All three treatments were safe and well tolerated. All occurrences of local and/or systemic signs and symptoms were mild or moderate in severity, except for one severe fatigue and myalgia in the QIV group and one severe headache in the OVX836 group.
Immunogenicity: Primary endpoint was achieved for the QIV and the OVX836+QIV, which triggered adequate immune response to the QIV (Hemagglutination Inhibition - HAI). Geometric mean fold-rise at Day 29 vs Day 1 of the HAI were similar between the QIV and OVX836+QIV groups for all strains contained in the QIV (figure 1). While there was an increase in NP-specific T-cell IFN-γ ELISPOT response at Day 8 for the OVX836 and the OVX836+QIV groups compared to QIV (p&lt; 0.0001, Wilcoxon rank-sum test), no significant difference was observed in terms of change (D8-D1) between OVX836 and OVX836+QIV – figure 2.
The analysis of additional NP-specific immune parameters supports similar conclusion, with no to very limited immune interference between vaccines.Figure 1:Geometric Mean Ratio of HAI for each strain of the QIV between D1 and D29Figure 2:Mean Change (+Standard Deviation) of IFNg ELISpot response b/w D1 and D8

Conclusion
OVX836 co-administered with QIV was safe, with no immune interference on either HAI or NP-specific IFN-γ ELISPOT, thus warranting further evaluation in larger trials.

Disclosures
Paul Willems, n/a, Osivax: Advisor/Consultant Jessika Tourneur, n/a, Osivax: Stocks/Bonds Delphine Guyon-Gellin, n/a, Osivax: Stocks/Bonds Alexandre Le Vert, Osivax: Board Member|Osivax: Stocks/Bonds Florence Nicolas, n/a, Osivax: Stocks/Bonds
373. An open-label 24-week randomised multicentered clinical trial of Bictegravir/Emtricitabine/Tenofovir Alafenamide compared to Tenofivir/Lamifuvine/Efavirenz as an initial regimen in Chinese late presenters with HIV-1 infection
Authors: Qin Ling , Lu Ruichao , Wang Rugang , Zhou Yingquan , Wei Hongxia , Ma Ping , Zhang Junyan , Lyu Wei 
Published: November 2023

Abstract

Background
Despite tremendous efforts, late presenters (CD4 ≤ 350 cells/μl) still account for a staggering proportion of HIV patients at the time of diagnosis. The main objective of this study was to evaluate the viral-immunological efficacy of bictegravir/emtricitabine/ tenofovir alafenamide (BIC/FTC/TAF) in treatment-naïve, late presenters in Chinese patients with HIV-1 infection, comparing with national free tenofovir disoproxil fumarate/lamivudine/efavirenz/(TDF/3TC/EFV).

Methods
We conducted an open-label, randomized controlled trial at six HIV care centers in China, starting recruitment from June 2021 to December 2022. All treatment-naïve late presenters were randomised to receive TDF/3TC/EFV (group A) or BIC/FTC/TAF (group B). Serum HIV loads and CD4 cell counts were measured at baseline, 4 weeks, 12 weeks, and 24 weeks. The proportion of HIV-RNA &lt; 50 copies/ml at 12 weeks was considered the primary endpoint and changes in viral loads and CD4 cell counts at other time points were secondary outcomes in PP and ITT analysis.

Results
We enrolled 200 late presenters, randomizing to group A (n=99) and group B (n=101). As of April 2023, 178/200 (89%) and 156/200 (78%) of randomized individuals completed 12 weeks and 24 weeks of follow-up. The study groups (n=200) were similar at baseline with a mean age of 43.0±13.8 years, 83.5% men, HBV co-infection percentage of 4%, HCV co-infection percentage of 2.5%, HIV viral load of mean 4.7±0.7 log copies/ml and CD4 cell counts of mean 109±74 cells/μl (Table 1). PP analysis showed 67.9% (57/84) of patients in group B had achieved viral suppression (&lt; 50 copies/mL) at 12 weeks in comparison to 48.1 % (37/77) of that in group A (p&lt; 0.01). The mean viral load levels decreased sharply in the drug B group from 4.70 ± 0.72 to 1.62 ± 0.47 log copies/ml over 12 weeks, compared to group A (p&lt; 0.01, figure 1). However, in the two groups, CD4 counts had a similar change trend over 24 weeks and the proportion of CD4 cell counts over 200 cells/μl remained identical (figure 2). ITT analysis further demonstrated the results above.

Conclusion
Compared to TDF/3TC/EFV, BIC/FTC/ TAF as the initial choice for late presenters had better performance to achieve rapid viral suppression, especially in the first three months therapy, but showed no superiority in immune deficiency improvement.

Disclosures
All Authors: No reported disclosures
379. Research nurses in Europe: education paths and key tasks, results from VACCELERATE
Authors: Salmanton-Garcia Jon , Stewart Fiona A , Wipfler Pauline , Hofstraat Sanne H I , Bruijning-Verhagen Patricia , Cornely Oliver A 
Published: November 2023

Abstract

Background
From January 2023, VACCELERATE offers a specific course to become “Research Nurse”. The term “Research Nurse” makes reference to nurses actively participating in the conduct of clinical trials and epidemiological studies. Despite being key to clinical research environment, the requirements of becoming a research nurse, or which tasks are assigned, might vary between countries. We aimed to depict the current situation in Europe-

Methods
Relevant bodies in charge of nursing education in general, and Research Nurses in particular, were contacted, following advice of the VACCELERATE National Coordinators and the VACCELERATE Site Network. Participants were asked to complete an online survey on Research Nurse.

Results
Responses from 38 countries were collected. Before becoming a Research Nurse, a nursing degree was necessary in 33 (87%) countries, for which training may take 3-5 years (Figure 1). A Good Clinical Practice (GCP) course was necessary to become a Research Nurse in 24 (63%) out of 38 countries. Overall, courses relevant for compliance with Research Nurse tasks are provided by different bodies, such as: online institutions (n=18, 47%), organisations external to the respective clinical trial unit (n=16, 42%), or on site at hospitals or universities (n=14, 37%, each). Eighteen (47%) countries reported the existence of dedicated Research Nurse courses in their boundaries, but 29 (76%) considered them necessary. Administration of investigational medicinal products (country n=33, 87%) was the most commonly assigned task, both in phase I-IV clinical trials and registry trials/observational studies. Other relevant tasks were processing of blood samples (n=32, 84%), patient training for new medicines/procedures (n=30, 79%), and shipment of clinical samples (n=29, 76%). Obtaining patient informed consent (n=18, 47%) or prescription of investigational medicinal products (n=6, 16%) was a task in only a few countries.education in their country.

Conclusion
Despite the baseline educational background varying widely between countries within Europe, the tasks assigned to Research Nurses
are generally similar, which may consist of study administrative tasks, sample processing and patient training.

Disclosures
Oliver A. Cornely, MD PhD, DZIF: Advisor/Consultant|DZIF: Board Member|DZIF: Grant/Research Support|DZIF: Honoraria|DZIF: Stocks/Bonds
390. Corticosteroid Treatment in Severe Patients with SARS-CoV-2 and Chronic HBV Co-infection: A Retrospective Multicenter Study
Authors: Biju Sanju , Paulson Shon , Raju Jomel 
Published: November 2023

Abstract

Background
The impact of corticosteroids on patients with severe coronavirus disease 2019 (COVID-19)/chronic hepatitis B virus (HBV) co-infection is currently unknown. We aimed to investigate the association of corticosteroids with these patients.

Methods
This retrospective multicenter study screened 5447 confirmed COVID-19 patients hospitalized between Jan 1, 2021, to December 1, 2022, in three centers in India, where the prevalence of chronic HBV infection is moderate to high. Severe patients who had chronic HBV and acute SARS-CoV-2 infection were potentially eligible. The diagnosis of chronic HBV infection was based on positive testing for hepatitis B surface antigen (HBsAg) or HBV DNA during hospitalization and a medical history of chronic HBV infection. Severe patients (meeting one of the following criteria: respiratory rate &gt; 30 breaths/min; severe respiratory distress; or SpO2 ≤ 93% on room air; or oxygen index &lt; 300 mmHg) with COVID-19/HBV co-infection were identified. The bias of confounding variables on corticosteroid effects was minimized using a multivariable logistic regression model and inverse probability of treatment weighting (IPTW) based on the propensity score.

Results
The prevalence of HBV co-infection in COVID-19 patients was 4.1%. There were 105 patients with severe COVID-19/HBV co-infections (median age 62 years, 57.1% male). Fifty-five patients received corticosteroid treatment and 50 patients did not. In the multivariable analysis, corticosteroid therapy (OR, 6.32, 95% CI 1.17-34.24, P = 0.033) was identified as an independent risk factor for 28-day mortality. With IPTW analysis, corticosteroid treatment was associated with delayed SARS-CoV-2 viral RNA clearance (OR, 2.95, 95% CI 1.63-5.32, P &lt; 0.001), increased risk of 28-day and in-hospital mortality (OR, 4.90, 95% CI 1.68-14.28, P = 0.004; OR, 5.64, 95% CI 1.95-16.30, P = 0.001, respectively), and acute liver injury (OR, 4.50, 95% CI 2.57-7.85, P &lt; 0.001). Methylprednisolone dose per day and cumulative dose in non-survivors were significantly higher than in survivors.

Conclusion
In patients with severe COVID-19/HBV co-infection, corticosteroid treatment may be associated with an increased risk of 28-day and in-hospital mortality.

Disclosures
All Authors: No reported disclosures