Background and Objectives : Outpatient parenteral antimicrobial therapy (OPAT) for infections has been in use for nearly 40 years, and although it has been found safe and efficacious, its use has been studied primarily among otherwise healthy patients. We aimed to develop and evaluate an OPAT program for patients with cancer, particularly solid tumors. Methods : We implemented multiple quality improvement interventions between June 2018 and January 2020. We retrospectively and prospectively collected data on demographics, the quality of infectious diseases (ID) physician consultation notes, rates of laboratory test result monitoring, ID clinic follow-up, and 30-day outcomes, including unplanned OPAT-related readmissions, OPAT-related emergency center visits, and deaths. Results : Completeness of ID provider notes improved from a baseline of 77% to 100% (p<.0001) for antimicrobial recommendations, 75% to 97% (p<.0001) for follow-up recommendations, and 19% to 98% (p<.0001) for laboratory test result monitoring recommendations. Completion of laboratory tests increased from a baseline rate of 24% to 56% (p=.027). Thirty-day unplanned OPAT-related readmission, ID clinic follow-up, 30-day emergency center visit, and death rates improved without reaching statistical significance. Conclusions : Sustained efforts, multiple interventions, and multidisciplinary engagement can improve laboratory test result monitoring among solid tumor patients discharged with OPAT. Although demonstrating a decrease in unplanned readmissions through institution of a formal OPAT program among patients with solid malignancies may be more difficult compared with the general population, the program may still result in improved safety.

Background We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. Methods In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged >= 18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978. Findings Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1.07 [95% CI 0.74-1.56]; BRII-196 plus BRII-198 0.98 [95% CI 0.67-1.43]) or the pulmonary-plus complications scale (sotrovimab 1.08 [0.74-1.58]; BRII-196 plus BRII-198 1.00 [0.68-1.46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1.12 [95% CI 0.91-1.37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1.08 [0.88-1.32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90. Interpretation Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19. Copyright (C) 2021 Elsevier Ltd. All rights reserved.

Background and objectives Outpatient parenteral antimicrobial therapy (OPAT) for infections has been in use for nearly 40 years, and although it has been found safe and efficacious, its use has been studied primarily among otherwise healthy patients. We aimed to develop and evaluate an OPAT program for patients with cancer, particularly solid tumors. Methods We implemented multiple quality improvement interventions between June 2018 and January 2020. We retrospectively and prospectively collected data on demographics, the completeness of infectious diseases (ID) physician consultation notes, rates of laboratory test result monitoring, ID clinic follow-up, and 30-day outcomes, including unplanned OPAT-related readmissions, OPAT-related emergency center visits, and deaths. Results Completeness of ID provider notes improved from a baseline of 77 to 100% ( p < .0001) for antimicrobial recommendations, 75 to 97% ( p < .0001) for follow-up recommendations, and 19 to 98% ( p < .0001) for laboratory test result monitoring recommendations. Completion of laboratory tests increased from a baseline rate of 24 to 56% ( p = .027). Thirty-day unplanned OPAT-related readmission, ID clinic follow-up, 30-day emergency center visit, and death rates improved without reaching statistical significance. Conclusions Sustained efforts, multiple interventions, and multidisciplinary engagement can improve laboratory test result monitoring among solid tumor patients discharged with OPAT. Although demonstrating a decrease in unplanned readmissions through institution of a formal OPAT program among patients with solid malignancies may be more difficult compared with the general population, the program may still result in improved safety.

Abstract Background Increasing rates of antimicrobial resistance require more frequent parenteral antimicrobial therapy. OPAT improves patient quality of life and is cost-effective. Although IDSA OPAT guidelines are applied to cancer patients, few studies have addressed implementation in this unique population. Through our quality improvement project, we aimed to improve monitoring of solid tumor patients recommended for OPAT by infectious diseases (ID) consultation as measured by an increased percentage of patients with physician follow-up and laboratory monitoring. Methods We used the plan-do-study-act methodology to guide our quality improvement project. To establish baseline frequencies, we retrospectively reviewed a subset of solid tumor patients seen for ID consultation and recommended for OPAT. We used brainstorming, fishbone analysis, and process mapping to analyze our current process. We standardized a sign-off note for inclusion with OPAT recommendations within our electronic medical record. We reminded ID providers of the new process weekly and to notify the OPAT team and outpatient clinical nursing staff of OPAT-enrolled patients. Results We found that clarifying recommendations addressed several identified obstacles to monitoring. After instituting our intervention, the percentage of patients who completed follow-up increased from 44% to 78% during the 6-week intervention period. Although the frequency of laboratory monitoring recommendations increased from 43% to 86%, the percentage of patients completing such monitoring did not improve. Our results were sustainable during the 3-month post-intervention observation period. Conclusion By standardizing ID recommendations, we increased outpatient follow-up frequency. Our inability to increase the frequency of laboratory monitoring likely reflects the increased complexity of the process, which requires action from external stakeholders. We learned that a simple intervention can have a meaningful impact and that gains can be limited without involvement of all stakeholders. We plan to expand to a comprehensive OPAT clinic for all patients at our facility and further characterize challenges and opportunities for utilizing OPAT in cancer patients. Disclosures All authors: No reported disclosures.

OBJECTIVE:Reported penicillin allergies result in alternative antimicrobial use and are associated with worse outcomes and increased costs. Penicillin skin testing (PST) has recently been shown to be safe and effective in immunocompromised cancer patients, yet its impact on antimicrobial costs and aztreonam utilization has not been evaluated in this population.METHOD:From September 2017 to January 2018, we screened all admitted patients receiving aztreonam. Those with a self-reported history of possible immunoglobulin E (IgE)-mediated reaction to penicillin were eligible for PST with oral challenge.RESULTS:A total of 129 patients were screened, and 49 patients were included and underwent testing. Sixteen patients (33%) had hematologic malignancies and 33 patients (67%) had solid tumors. After PST with oral challenge, 46 patients (94%) tested negative, 1 patient tested positive on oral challenge, and 2 patients had indeterminate results. The median time from admission to testing was 2 days (interquartile range, 1-4). After testing negative, 33 patients (72%) were switched to beta-lactam therapy, which resulted in a total of 390 days of beta-lactam therapy. For identical therapy durations, the direct total antibiotic cost was $15 138.89 for beta-lactams versus $78 331.50 for aztreonam, resulting in $63 192.61 in projected savings. A significant reduction in median days of aztreonam therapy per 1000 patient days (10.0 vs 8.0; P = .005) was found during the intervention period.CONCLUSIONS:Use of PST in immunocompromised cancer patients receiving aztreonam resulted in improved aztreonam stewardship and significant cost savings. Our study demonstrates that PST with oral challenge should be considered in all cancer patients with reported penicillin allergies.

During 2017, Houston had the most destructive flood-related disaster in recent history due to Hurricane Harvey. Afterward, educational material with information of possible ID problems was provided to all healthcare workers. Prospective surveillance of flood-related ID complications in IC cancer patients. During the 60 days post-Harvey, we monitored referrals to the ID service at MDA Cancer Center. We used the following definitions: Type of exposure: direct to flood water, direct to flooded structures, and others indirect (i.e., prophylaxis). Association risk: “Yes” (direct exposure), “No” (asymptomatic, no exposure, or infection noted prior) and “Probable” (lack of records to establish correlation). Types of infections were classified as soft tissue, gastrointestinal, respiratory, IV line associated or fever. Recommendations were noted including types of antibiotics, vaccinations, or imaging. A total of 36 cases were referred to our department. Fifty-six percent had exposure to flood-water with/without exposure to structures, 33% to structures only and 11% were other (Figure 1). Regarding the association of an ID problem to flood-exposure, we found an equal distribution of 39% with an association and 39% with a probable association, and the remaining 22% with no association (Figure 2). Of the infections, the majority of infections were respiratory (42%) or soft tissue (31%) (Figure 3). There was a trend of broader antimicrobial coverage for water associated bacteria and mold infections. Only six immunizations recommendations were attained. To our knowledge this is the first and largest study of ID complications in IC cancer patients following a natural disaster in medical literature. Our active surveillance showed a lower number of disaster related ID complications than anticipated, possibly because of difficulty determining exposure and underreporting of infections despite active education. Due to individual immunosuppression and exposure, there was variety of recommendations (antimicrobials, studies, or vaccinations). In the event of a weather disaster, we are developing a standard triage survey regarding type of exposure and impact, and also a process for effective immunizations. J. Adachi, Merck: Grant Investigator, Research grant