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Abstract Background Outpatient peripherally inserted central catheters (PICC) use has grown without standardized protocols for their management. We assessed the impact of a mobile app strategy for outpatient CLABSI prevention using photo-monitoring, assessment, and response to lines with local inflammation/infection in a cohort of cancer clinic patients. Methods This prospective cohort study evaluated adults with PICCs at an academic cancer clinic at baseline (7/2015–12/2016) and after implementing the SAFER (Standardizing Assessment For Effective Response) Lines program (intervention 5/2017–11/2018). This included a mobile app enabling (1) clinic assessment of localized inflammation or infection defined as Central Line Insertion Site Assessment (CLISA) score 2 or 3, respectively (Table 1), (2) photo-documentation, and (3) score-based automated physician alerts for remote response. We assessed demographics, malignancy type, and line characteristics. Generalized linear mixed effects model assessed program impact on frequency of CLISA 2 or 3 lines, clustered by patient. Cox proportional hazards and Kaplan Meier models assessed days to line removal after CLISA 2 or 3 were identified. Results Among 4,894 assessments of 528 PICCs in 380 outpatients, there were 272 lines (199 patients) at baseline and 256 lines (181 patients) after SAFER program implementation. Mean age, gender, PICC dwell time, and history of prior PICC were similar at baseline and intervention. The proportion of inflamed (CLISA 2) and infected (CLISA 3) lines decreased 40% (from 26% to 16%, and 19% to 11%, respectively) during intervention compared to baseline. Lines with peeling dressings decreased 80% (from 46% to 9%). Mean days to removal of inflamed lines decreased 59% (from 19 to 8 days); removal of infected lines decreased 85% (from 11 to < 2 days). Intervention was associated with 46% lower risk of local inflammation/infection (OR 0.46, CI=0.26–0.83, p< 0.01, Table 2) and faster line removal when such lines were identified (HR 0.18, CI=0.12–0.27, p< 0.01). Conclusion The SAFER Lines mobile app and program decreased the frequency of locally inflamed or infected PICC insertion sites and increased the speed of removal when local inflammation/infection was found in cancer clinic patients. Disclosures Raheeb Saavedra, AS, Medline: Conducted studies in which hospitals and nursing homes received contributed antiseptic and/or environmental cleaning products|Stryker: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products|Xttrium Laboratories: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products Raveena D. Singh, MA, Medline: Conducted studies in which hospitals and nursing homes received contributed antiseptic and/or environmental cleaning products|Stryker: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products|Xttrium Laboratories: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products Susan S. Huang, MD, MPH, Medline: Conducted studies in which hospitals and nursing homes received contributed antiseptic and/or environmental cleaning products|Molnlyke: Conducted clinical studies in which hospitals received contributed antiseptic product|Stryker: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products|Xttrium Laboratories: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic product.

ObjectiveTo assess the impact of a newly developed Central-Line Insertion Site Assessment (CLISA) score on the incidence of local inflammation or infection for CLABSI prevention.DesignA pre- and postintervention, quasi-experimental quality improvement study.Setting and participantsAdult inpatients with central venous catheters (CVCs) hospitalized in an intensive care unit or oncology ward at a large academic medical center.MethodsWe evaluated CLISA score impact on insertion site inflammation and infection (CLISA score of 2 or 3) incidence in the baseline period (June 2014-January 2015) and the intervention period (April 2015-October 2017) using interrupted times series and generalized linear mixed-effects multivariable analyses. These were run separately for days-to-line removal from identification of a CLISA score of 2 or 3. CLISA score interrater reliability and photo quiz results were evaluated.ResultsAmong 6,957 CVCs assessed 40,846 times, percentage of lines with CLISA score of 2 or 3 in the baseline and intervention periods decreased by 78.2% (from 22.0% to 4.7%), with a significant immediate decrease in the time-series analysis (P < .001). According to the multivariable regression, the intervention was associated with lower percentage of lines with a CLISA score of 2 or 3, after adjusting for age, gender, CVC body location, and hospital unit (odds ratio, 0.15; 95% confidence interval, 0.06-0.34; P < .001). According to the multivariate regression, days to removal of lines with CLISA score of 2 or 3 was 3.19 days faster after the intervention (P < .001). Also, line dwell time decreased 37.1% from a mean of 14 days (standard deviation [SD], 10.6) to 8.8 days (SD, 9.0) (P < .001). Device utilization ratios decreased 9% from 0.64 (SD, 0.08) to 0.58 (SD, 0.06) (P = .039).ConclusionsThe CLISA score creates a common language for assessing line infection risk and successfully promotes high compliance with best practices in timely line removal.

Abstract Standard therapy for recurrent GBM is bevacizumab, a monoclonal VEGF inhibitor that targets tumor vascularization. The response to bevacizumab is transient and short-lived (4–6 months) after which patients typically develop progressive physical and mental debilitation culminating in death. ERC1671 is an allogeneic/autologous therapeutic vaccine – composed of whole, inactivated tumor cells mixed with tumor- cell lysates. The hypothesized action of ERC1671 is to potentiate the patients’ immune system against the tumor. Goals of this ongoing, phase 2 study are to to determine the safety and effectiveness (over-all survival) of ERC1671 in combination with GM-CSF and cyclophosphamide as an add-on treatment to bevacizumab at the time of GBM recurrence. To date 16 recurrent bevacizumab-naïve GBM patients have been randomized to ERC1671/GM-CSF/Cyclophosphamide + Bevacizumab or Placebo + Bevacizumab. Median age is 56.5 (39–74), 5 patients (31%) are female, and average KPS is 83 (70–100). Thirteen patients are deceased and were unblinded at the time of further progression: 5 received vaccine, 7 received placebo, and 1 is non-evaluable due to discontinuation before completing 1 cycle. Median overall survival of the deceased patients treated with ERC1671 + Bevacizumab was 328 days (10.9 months), compared to 245 days (8.2 months) for patients treated with Placebo + Bevacizumab. While sparse, the data to date suggest pre-treatment and maximal CD4+T lymphocyte count in the peripheral blood correlate with OS more strongly in the ERC1671 group than in the placebo group. First clinical results for toxicity show no difference in the distribution of AEs between the Vaccine and Placebo groups, with no Gr4/Gr5 AEs in either group. The phase 2 randomized, double-blinded study is ongoing with the addition of 2 subsites.

Abstract Newly-diagnosed glioblastoma (GBM) patients have a limited survival (18–24 months). In the last decade immunotherapy has improved survival for patients with other malignancies, but not GBM. Herein we present the design and initial enrollment results for the AV-GBM-1 single-arm phase 2 trial. The study enrolls patients with primary GBM who have undergone craniotomy, have a tumor cell culture established, and complete satisfactory leukapheresis prior to planned concurrent chemotherapy and radiation. Patients are scheduled to receive up to 8 vaccine injections at weeks 1, 2, 3, 8, 12, 16, 20 and 24. Blood samples are collected just prior to each injection. The primary endpoint is overall survival from date of enrollment for intent-to-treat with AV-GBM-1. The study has fully enrolled 26 of planned 55 patients. The cell line success rate is 30/32, with 6 in progress; successful completion of leukapheresis is 28/29. Two patients have completed all 8 doses, two discontinued after dose 3 and dose 6 because of progressive disease; 15 are currently in treatment, and 6 are about to start treatment. There have been seven SAE, all for hospitalizations related to GBM. For the first 8 treated patients, plasma samples from baseline and weeks 2, 3, and 8 have been analyzed for immune markers by RayBiotech Life Inc. using quantitative multiplex ELISA array. Markers reflecting Th1, Th2, Th17 pathways and B-cells, natural killer cells and cytotoxic T-lymphocytes increased in 7/8 patients. Principal component analysis demonstrates correlative marker groupings with early dominance of Th1/Th17 (weeks 1 and 2) followed by Th2/immunoglobulins at week 8. These findings show that these patient-specific dendritic cell vaccines are inducing pro-inflammatory responses similar to what was observed in a previous trial in melanoma. The study is progressing efficiently. Full enrollment data may be available for presentation at the time of the annual meeting.

ImportanceAlthough patients with acute stroke are routinely evaluated for potential treatment (ie, treatability of the stroke), preventability of the presenting stroke is generally not seriously considered.ObjectiveTo systematically analyze stroke preventability.Design, setting, and participantsWe evaluated medical records of 274 consecutive patients discharged with a diagnosis of ischemic stroke between December 2, 2010, and June 11, 2012, at the University of California Irvine Medical Center. Mean (SE) patient age was 67.2 (0.8) years. Data analysis was conducted from July 3, 2014, to August 4, 2015.ExposuresMedical records were systematically examined for demographic information, stroke risk factors, stroke severity, and acute stroke treatment.Main outcomes and measuresWe defined stroke preventability as the degree to which the patient's presenting stroke was preventable. Using variables easily determined at onset of stroke, we developed a 10-point scale (0, not preventable; 10, most preventable) to classify the degree of stroke preventability. Our focus was effectiveness of treatment of hypertension (0-2 points), hyperlipidemia (0-2 points), and atrial fibrillation (0-4 points), as well as use of antithrombotic treatment for known prior cerebrovascular and cardiovascular disease (0-2 points).ResultsTotal risk scores ranged from 0 to 8 (mean [SE], 2.2 [0.1]), with 207 patients (75.5%) exhibiting some degree of preventability (score of 1 or higher). Seventy-one patients (25.9%) had scores of 4 or higher, indicating that the stroke was highly preventable. Severity of stroke as determined by the National Institutes of Health Stroke Scale score was not related to preventability of stroke. However, 21 of 71 patients (29.6%) whose stroke was highly preventable were treated with intravenous or intra-arterial acute stroke therapy while these treatments were provided for only 13 of 67 patients (19.4%) with scores of 0 (no preventability) and 19 of 136 patients (14.0%) with scores of 1 to 3 (low preventability) (P = .03).Conclusions and relevanceMost patients with acute stroke exhibited some degree of preventability. Preventability and treatment of stroke were significantly associated, indicating that the most preventable strokes paradoxically were more likely to receive acute treatment.

Background: Recent increases in opioid use and subsequent opioid use disorder are a major public health crisis in the United States. Aims: This phase 1 randomized, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics (PKs) of ASP8062, a γ-aminobutyric acid B receptor-positive allosteric modulator, with and without administration of morphine in participants who used opioids recreationally. Methods: Participants were randomly assigned (2:1) to daily dosing with ASP8062 25 mg or placebo on days 1–10. On day 10, all participants received morphine as a single oral dose of 45 mg; assessments were performed on days 11–16. The primary end point was safety, evaluated as the nature, frequency, and severity of adverse events, and end-tidal CO2 levels. PK end points were a secondary outcome measure. Results: A total of 24 participants (aged 21–54 years) received ASP8062 (n = 16) or placebo (n = 8). There were no deaths or serious adverse events leading to treatment discontinuation during the study. Most adverse events were mild, with numerically lower absolute number of adverse events reported with ASP8062 plus morphine versus placebo plus morphine. ASP8062 plus morphine did not increase respiratory depression, potential drug abuse- or withdrawal-related adverse events. There were no significant PK interactions. Conclusions: In this phase 1 study, we did not observe any unexpected safety signals or notable PK interactions with concomitant morphine administration. These data suggest a potentially low risk for an increase in drug abuse- or withdrawal-related adverse events or respiratory distress in participants exposed to ASP8062 and morphine. [ABSTRACT FROM AUTHOR]

Each day a venous catheter is retained poses unnecessary safety risks. In a retrospective evaluation of central/peripheral lines in nursing home residents receiving antibiotics, 80% were retained beyond antibiotic treatment end and nearly one third were retained longer than a week. Interventions for timely catheter removal are urgently needed.

Objectives: To evaluate the impact of a mobile-app-based central line-associated bloodstream infection (CLABSI) prevention program in nursing home residents with peripherally inserted central catheters (PICCs)., Design: Pre-post prospective cohort study with baseline (September 2015-December 2016), phase-in (January 2017-April 2017), and intervention (May 2017-December 2018). Generalized linear mixed models compared intervention with baseline frequency of localized inflammation/infection, dressing peeling, and infection-related hospitalizations. Cox proportional hazards models compared days-to-removal of lines with localized inflammation/infection., Setting: Six nursing homes in Orange County, California., Patients: Adult nursing home residents with PICCs., Intervention: CLABSI prevention program consisting of an actionable scoring system for identifying insertion site infection/inflammation coupled with a mobile-app enabling photo-assessments and automated physician alerting for remote response., Results: We completed 8,131 assessments of 817 PICCs in 719 residents (baseline: 4,865 assessments, 422 PICCs, 385 residents; intervention: 4,264 assessments, 395 PICCs, 334 residents). The intervention was associated with 57% lower odds of peeling dressings (OR 0.43, 95% CI 0.28-0.64, P < .001), 73% lower local inflammation/infection (OR = 0.27, 95% CI: 0.13-0.56, P < .001), and 41% lower risk of infection-related hospitalizations (OR = 0.59, 95% CI: 0.42-0.83, P = .002). Physician mobile-app alerting and response enabled 62% lower risk of lines remaining in place after inflammation/infection was identified (HR 0.38, CI: 0.24-0.62, P < .001) and 95% faster removal of infected lines from mean (SD) 19 (20) to 1 (2) days., Conclusions: A mobile-app-based CLABSI prevention program decreased the frequency of inflamed/infected central line insertion sites, improved dressing integrity, increased speed of removal when inflammation/infection were found, and reduced infection-related hospitalization risk.