bluuebunny/crossref_metadata_2025_split huggingface dataset:
Painting the Gown Red: Using a Colored Paint Quality Improvement Process to Evaluate Healthcare Worker Personal Protective Equipment for Highly Pathogenic Infections
Authors: Eiras Daniel , Echeverri Andrea , Toale Kieran , Tennill Patricia , Evans Laura 
Published: October 2017

Abstract

Background
Personal protective equipment (PPE) and strict infection control techniques are the primary methods by which healthcare workers (HCW) can avoid exposure during the treatment of patients with highly pathogenic infections such as Ebola Virus Disease (EVD) or the Middle East Respiratory Syndrome coronavirus (MERS-CoV). There is currently no consensus for the types of PPE that are recommended to be worn by HCWs, nor is there a universal process for the donning and doffing of PPE.

Methods
HCWs from Bellevue Hospital participate in quarterly PPE trainings as part of the Special Pathogens Program (SPP), which consist of didactic sessions as well as an evaluation of donning and doffing techniques. A total of 50 HCWs completed the training curriculum in 2017. During the doffing process, PPE trainers applied corn start powder paint (Chameleon Colors; American Fork, UT) to the participants’ gloved hands between multiple steps of PPE removal. At the end of the process, the areas where paint was found on was documented including the outer surgical gown, the powered air purifying respirator (PAPR) helmet and shroud, the inner impermeable suit, the knee-high boots and boot covers, and the extended-cuff gloves.

Results
The areas of PPE that were most marked with paint were the lower shoulders and upper arms of the surgical gowns, the top sides of the PAPR shroud, the front upper chest area, and the center back of the inner impermeable suits. In a majority of cases no powder paint was noted on the knee-high boots. In a minority of cases, paint was observed on the inside upper chest area of the surgical gown. These paint markings were used to discuss potential breaches in PPE doffing technique in real-time, as well as identify areas to target in future PPE trainings.

Conclusion
The powdered paint quality improvement process for donning and doffing PPE is a method to evaluate the complex PPE dressing procedure. It is particularly useful given the fact that it is incumbent on each hospital or healthcare system to develop its own processes and procedures for PPE, as well as maintain readiness through periodic trainings. Powdered paint can identify vulnerabilities in their process as well as areas that require further education.

Disclosures
All authors: No reported disclosures.
Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Candidate Vaccine in Adults with Hematologic Malignancies: A Phase III, Randomized Clinical Trial
Authors: Oostvogels Lidia 
Published: October 2017

Abstract

Background
Hematologic malignancy (HM) patients receiving immunosuppressive cancer therapy (ICT) are at increased risk of herpes zoster (HZ). Currently, no HZ vaccine is indicated for immunocompromised patients. The HZ subunit vaccine candidate (HZ/su), containing recombinant varicella zoster virus glycoprotein E and AS01B Adjuvant System, showed &gt;90% efficacy and an acceptable safety profile in immunocompetent adults in all age groups ≥50 years. Here we report HZ/su immunogenicity and safety in HM adults ≥18 years of age who completed or are undergoing ICT.

Methods
In this phase III, observer-blind, multicenter study (NCT01767467), participants were randomized 1:1 to receive HZ/su or placebo (2 doses, 1–2 months apart) ≥10 days pre- or post-ICT. Humoral and cell-mediated immunogenicity (CMI) were assessed. The co-primary immunogenicity objectives were to evaluate HZ/su vaccine response rate and compare the immune response to HZ/su and placebo in participants excluding those with non-Hodgkin B-cell lymphoma (NHBCL) or chronic lymphocytic leukemia (CLL) at 1 month post-dose 2 (M2). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Serious AEs (SAEs), disease-related events and potential immune-mediated diseases (pIMDs) were recorded throughout the study. Partial safety results up to 6 months post-dose 2 are shown (partially blinded, ongoing study).

Results
Of 562 participants (283 HZ/su 283; placebo 279), (mean age 57.3 [HZ/su 56.8; placebo 57.8] years), 415 were included in the according-to-protocol (ATP) cohort for humoral immunogenicity and 132 in the ATP sub-cohort for CMI. M2 immune responses were higher in the HZ/su group (Table 1). Both co-primary immunogenicity objectives were met (Figure 1). The most frequent local and general solicited AEs were pain and fatigue, reported by 48.2% and 47.8% of all participants (per-group data remain blinded). The frequency of unsolicited AEs, SAEs and pIMDs in the 2 groups was similar (Table 2).

Conclusion
HZ/su induced robust humoral and cellular immune responses at M2 in HM adults excluding NHBCL and CLL, who completed or are undergoing ICT. No safety concerns were observed up to 6 months post-dose 2.

Funding
GlaxoSmithKline Biologicals SA

Disclosures
L. Oostvogels, GSK group of companies: Employee and Shareholder, Salary and Shares
Mortality and Retention in Care of HIV-Infected Patients According to Year of Admission and Availability of Antiretroviral Drugs in the Chilean National AIDS Program: Fundacion Arriaran 1990–2015
Authors: Wolff Marcelo , Northland Rebeca , Lizana Danae , Cortes Claudia P 
Published: October 2017

Abstract

Background
The HIV epidemic reached Chile in the mid 1980s, as response a national AIDS commission was created, AIDS care centers were organized (Fundacion Arriaran [FA] was the first) and free antiretroviral therapy (ART) was later provided with progressive coverage, complexity and availability over the years
Objective. Quantify evolution of mortality, retention and abandonment (LTFU) over 25 years according to qualitatively different periods in the national program of access to ART, from no availability to full coverage with current drugs at FA center

Methods
Retrospective analysis of FA updated database of the 5080 adult patients admitted from 1990 to 2014, who were distributed in 4 groups: A: no ART availability (1990–92); B: mono/dual ART (1993–98); C: early modern ART (HAART) (1999–2007) and D: contemporary HAART (2008–14). Mortality, Retention and LTFU were evaluated at 1, 3, 5 and 10 year intervals from admission and at end of 2015. Mortality was included in period of occurrence; LTFU was permanent absence at center of &gt; 6 months during studied period. Local IRB approved the study

Results
Main results shown in Table. Mortality varied from 40% to 2%, and 62% to 7% at 1 and 5 years, for groups A and D respectively; 72% to 16% at 10 years for groups A and C, respectively. Retention at 5 years were 28%, 32%, 72% and 77% for groups A, B, C and D respectively. LTFU was 10%, 17%, 12% and 10% at 5 years for same groups, respectively. At 12/2015 6%, 19%, 61% and 84% from groups A, B, C and D, respectively, remained retained in care

Conclusion
This study showed the marked reduction in mortality and increase in retention of HIV patients concomitant to expanded access to therapy although LTFU remains a problem.

Disclosures
All authors: No reported disclosures.
Lack of Clinically Relevant Effect of Bictegravir (BIC, B) on Metformin (MET) Pharmacokinetics (PK) and Pharmacodynamics (PD)
Authors: Custodio Joseph , West Steve , Yu Amanda , Martin Hal , Graham Hiba , Quirk Erin , Kearney Brian 
Published: October 2017

Abstract

Background
BIC is a novel integrase inhibitor coformulated with emtricitabine (F) and tenofovir alafenamide (TAF) for treatment of HIV. MET is first-line therapy in diabetic HIV patients. In vitro, BIC inhibits renal transporters OCT2 and MATE1, which affect MET disposition. This study evaluated the effect of BIC on the PK and PD of MET following coadministration with the B/F/TAF.

Methods
This was a Phase 1, blinded, placebo-controlled, crossover study in 32 healthy subjects randomized 1:1 to either B/F/TAF or placebo QD for 9 days followed by a 3-day washout. Following 4 days of B/F/TAF or placebo, subjects received 850 mg MET at 12 hours postdose of B/F/TAF or placebo, and 500 mg BID for 4 additional days. Plasma and urine PK of MET were assessed on the last treatment day (Days 9 and 21 for B/F/TAF or placebo). Oral glucose tolerance test was performed before (Days 5 and 17) and after MET (Days 9 and 21). MET PD endpoints including plasma glucose, active Glucagon-Like Peptide 1 (GLP-1) and lactate were assessed after glucose intake. Geometric mean ratios (GMR) and 90% confidence intervals (CIs) for MET PK were calculated for B/F/TAF vs. placebo. Comparisons of PD responses within treatments (before vs. after MET) and comparisons between treatments (B/F/TAF vs. placebo) were done via nonparametric Wilcoxon signed-rank test (P &gt; 0.05 denotes non-significance).

Results
MET plasma AUCtau was increased 39% (%GMR [90% CI]: 139 [131, 148]) with B/F/TAF vs. placebo, with no change in median plasma t1/2 (B/F/TAF: 6.4 hours; placebo: 7.1 hours). MET renal clearance decreased 31% with B/F/TAF vs. placebo. Following MET administration, statistically significant reduction of plasma glucose, and increase of plasma active GLP-1 and lactate levels relative to baseline were observed (P &lt; 0.001) confirming their utility as PD endpoints. Importantly, PD responses were not statistically different when MET was administered with B/F/TAF vs. placebo (p &gt;0.05).

Conclusion
Inhibition of renal transporters OCT2/MATE1 by BIC led to a modest increase of MET plasma exposure upon coadministration with B/F/TAF; however, the PD characteristics of MET were not significantly affected by B/F/TAF relative to placebo. Based on these findings, prospective dose adjustment/restriction of MET is not required upon coadministration with B/F/TAF.

Disclosures
J. Custodio, Gilead Sciences: Employee and Shareholder, Salary; S. West, Gilead Sciences: Employee and Shareholder, Salary; A. Yu, Gilead Science: Employee, Salary; H. Martin, Gilead Sciences: Employee, Salary; H. Graham, Gilead Sciences: Employee and Shareholder, Salary; E. Quirk, Gilead: Employee and Shareholder, Salary; B. Kearney, Gilead: Employee and Shareholder, Salary
Clearance of ceftazidime-avibactam in an in vitro continuous venovenous hemodialysis model
Authors: Bunnell Kristen L , Wenzler Eric , Danziger Larry H , Rodvold Keith A 
Published: October 2017

Abstract

Background
Optimal dosing of ceftazidime-avibactam (C-A) in critically ill patients on continuous renal replacement therapy (CRRT) is unknown. The objective of this study was to evaluate the adsorption and transmembrane clearance (CLTM) of C-A in an in vitro continuous venovenous hemodialysis (CVVHD) model to guide dosing in the absence of clinical data.

Methods
CVVHD was simulated with bovine blood (200 mL/minute) on a Prismaflex dialysis unit with polysulfone (HF1400) and AN69 (M150) hemofilters at dialysate flow rates (Qd) of 2 and 4 L/hours. Pre-hemofilter plasma samples were collected at 0, 5, 10, 20, 30, 45, and 60 mins after C-A addition; postfilter and dialysate samples were collected at 10 and 45 mins for saturation coefficient (SA) calculation. Adsorption was determined by total drug recovery in dialysate and plasma after 120 mins of dialysis at 2 L/hours. CLTM was calculated as the product of SA and Qd (CLTM-SA) and by elimination rate constant (CLTM-ke) derived from the slope of log-linear concentration-time plots.

Results
Mean (± SD) SA and CLTM values for C-A from duplicate experiments are in Table 1. CLTM was not affected by filter type, and increased linearly with Qd when calculated by two different methods. Avibactam CLTM was higher than ceftazidime CLTM with each filter and rate. Adsorption affected 17.3% and 20.2% of C-A for HF1400 and AN69 filters, respectively.

Conclusion
Significant Qd- dependent clearance of C-A was observed in in vitro CVVHD. CLTM of ceftazidime was slightly higher than previous reports and may reflect the larger surface area of contemporary filters in this study. The more rapid clearance of avibactam, particularly at higher flow rates, suggests that dose adjustments should focus on ensuring adequate avibactam exposure during CVVHD.

Disclosures
L. H. Danziger, Allergan: Investigator, Research grant.
Mapping Pediatric Tetanus Cases in Central Pennsylvania and Analyzing Hospital Costs Associated with Treatment
Authors: Ahmed Bilaal , Beck Michael , Kumar Parvathi 
Published: October 2017

Abstract

Background
Pennsylvania is home to Amish and Mennonite communities with an estimated combined population of over 90,000 people. Under-immunization is common with vaccine preventable diseases, including tetanus, periodically presenting among children from these communities. Nearly 20% of nationally reported pediatric tetanus cases in the past 10 years were treated at our institution, the tertiary care center which serves these unique populations. We characterize demographics and costs of treating this rare, but largely preventable infection.

Methods
Chart review based on ICD-9 codes for tetanus infection in patients aged 0–17 years treated for clinically diagnosed tetanus infection between January 2006 and December 2015. Cost data were extracted from Horizon Business Insight software and analyzed in Microsoft Excel. Cases were mapped using UDS Mapper.

Results
Four cases of pediatric tetanus infection were identified with 100% occurring in unimmunized patients and 3 of 4 (75%) in Amish individuals. Treatment costs amounted to $121,170 with estimated payment of $80,664 resulting in a net loss to the hospital of $40,506 over the course of 10 years. Each case treated resulted in a median loss of $4,402 to the hospital.

Conclusion
The costs of treating this vaccine preventable disease for both hospitals and under-immunized Amish and Mennonite communities, who tend to pay out-of-pocket, should be emphasized in targeted outreach and education programs at the population level.

Disclosures
All authors: No reported disclosures.
Joint Consultation Clinic by Infectious Diseases Specialists and Podiatry team (ID-POD) Compliments the Care of Diabetic Patients with Foot Infections by Reducing Cost and Decreasing Outpatient Clinic Visits
Authors: Lingegowda Pushpalatha Bangalore , Ooi Say-Tat , Somani Jyoti , Law Chelsea , Yeo Boon Kiak 
Published: October 2017

Abstract

Background
Management of diabetic foot infections (DFI) is challenging and involves multidisciplinary teams to improve outcomes (1). Appropriate wound care of patients with DFI plays an important role in successfully curing infections and promote wound healing. In Singapore, Infectious Diseases (ID) specialists help in the management of DFI by recommending appropriate antibiotics for infected wounds while wound debridement are managed by Podiatrists (POD). When patients are hospitalized multidisciplinary teams including Vascular Surgery review patients. In the outpatient setting patients have multiple appointments including ID and Endocrinology etc. The time spent and costs incurred by patients for traveling to multiple appointments is considerable. A joint ID-POD clinic was initiated to reduce the cost and inconvenience for patients.

Methods
A joint weekly clinic was initiated in October’16 and the data was analyzed upto May’17. Finance was involved in deriving costs. The service costs for consultations payable by patients before and after the initiation of the joint clinic were compared.

Results
First 6 months experience of initiating the joint ID-POD clinic is reported. 35 unique patients had a total of 88 visits. 1/third of the patients had more than 2 visits to the joint clinic. For each visit to the joint clinic the patient paid 25% less compared with having separate clinics. The hospital lowered the service cost for the new clinic by 11%. This was done by minimizing the time involvement of the ID physician.

Conclusion
Joint ID-POD clinic for managing diabetic patients with foot infections revealed several advantages. Hospital outpatient visits for each patient decreased by 50% for those requiring care of both ID and POD, without compromising care. With the consolidation of care each individual patient had a cost savings of 25% for the joint consultation. This joint clinic while making it convenient for patients has revealed significant cost savings to patients especially for those requiring multiple visits. We recommend hospitals with high prevalence of Diabetes and Diabetic foot infections to consider joint ID-POD clinics to reduce hassle and increase saving for patients.

Disclosures
All authors: No reported disclosures.
Potentially Inappropriate Durations of Anti-Infective Therapy at Hospital Discharge Despite Inpatient Antimicrobial Stewardship
Authors: Fox Neal , Haines Lauren , Bull Rachel , Jenkins Zachary , Ballentine John , Burdette Steven , Pleiman Craig 
Published: October 2017

Abstract

Background
Excess durations of anti-infective therapy are a common problem that may lead to unintended consequences. Antimicrobial stewardship (AMS) is a growing field that largely focuses on inpatient anti-infective use. For this study, one site was an academic medical center whose AMS uses prospective auditing; the other was a community hospital with pharmacy-driven AMS. Little research has examined durations of anti-infective therapy at hospital discharge.

Methods
Patient charts were reviewed and 284 were included in the final analysis. Patients were excluded if discharged on non-oral anti-infectives or only agents for a non-study indication. Patients were included if they were discharged on oral anti-infective therapy for CAP, healthcare-associated pneumonia (HCAP), UTI, cellulitis, and superficial abscess. Evidence-based durations of therapy were utilized to determine the potential inappropriateness of anti-infective therapy. Guidelines from the study period were used. Total duration of therapy was derived from the combination of outpatient therapy plus inpatient therapy beginning with the first day of relevant coverage for the given indication. Descriptive statistics were utilized to compare durations of therapy. Chi-squared tests were utilized to examine differences in expected frequencies. All statistics were performed in SPSS v. 24.

Results
The average combined duration of therapy was 11.3 days. 190 patients (66.9%) were found to have a potentially inappropriate duration of oral anti-infective therapy at hospital discharge. Only 2 durations were too short. Figure 1 displays the distribution of excess days of therapy. Figure 2 shows the breakdown of potential inappropriateness of duration by diagnosis. Figure 3 displays the percentage of potentially inappropriate cases by site. There were no significant differences in the primary outcome between the sites.

Conclusion
CAP and cellulitis appear to be areas that are often overtreated. Discharge durations of therapy should be a focus of AMS teams. Many patients receive potentially inappropriate durations of therapy at discharge without any discernible benefit. Further research is needed in this area.

Disclosures
All authors: No reported disclosures.
Safety and Effectiveness of Outpatient Parenteral Antimicrobial Therapy (OPAT) in the Aged Population
Authors: Van Anglen Lucinda J , Mandel Richard M , Nathan Ramesh V , Krinsky Andrew H , Luu Quyen , Bacon Alfred E , Baker H Barry , Schroeder Claudia P , Couch Kimberly A 
Published: October 2017

Abstract

Background
The aged population (≥75 years) have multiple comorbidities and are at increased risk of adverse events associated with intravenous antimicrobial therapy. Hospitalization (hosp) occurs frequently. This group presents challenges for site of care and reimbursement, which may be met with provision of OPAT through a physician office infusion center (POIC). This setting allows treatment immediately following hosp or directly from the community, thus avoiding hosp. For the aged patient (pt) population, we evaluated safety and effectiveness of OPAT in a POIC.

Methods
Records from 13 POICs were queried for patients ≥75 years receiving OPAT courses from January to July 2016. Data included demographics, therapy, disease characteristics, effectiveness and safety. Effectiveness was assessed as completion of therapy and no unplanned hosp related to the underlying infection. Safety assessment included adverse drug reactions (ADRs), catheter complications (CC) and hosp admissions for causes other than those related to the underlying infection. Descriptive statistics and regression analyses were performed.

Results
There were 260 OPAT patient courses provided. Mean age was 81 ± 5 years, 64% male. 51% were treated directly from the community and 49% post hosp. The most common infections were bone and joint (32%), genitourinary (21%), skin and skin structure (20%) and respiratory (12%). OPAT met criteria for effectiveness in 95%, with 247/260 completing therapy and avoiding infection-related hosp. Antimicrobials most frequently used were vancomycin (n = 59), ceftriaxone (n = 43), cefepime (n = 35) and ertapenem (n = 32). Median length of OPAT was 14 days (range 1–79). OPAT was assessed as safe in 81% of patients (211/260). 49 patients reported ≥1 safety events including ADRs (40; 15%), CC (6; 2.3%), and hosp (17; 6.5%). 9 hosp patients completed OPAT following discharge. Most common ADRs were diarrhea (n = 9), fatigue (n = 9) and nausea (n = 8) with 4 hosp for serious ADRs. All CCs resolved and there were no mortalities. Significant risk factors associated with safety events were drug allergies (OR=2.47, CI=1.31–4.65, P = 0.005), ≥3 comorbidities (OR=3.92, CI=1.16–13.23, P = 0.027) and hypertension (OR=2.19, CI=1.04–4.64 P = 0.039).

Conclusion
Provision of OPAT through a POIC demonstrated to be exceptionally safe and effective in the aged population.

Disclosures
L. J. Van Anglen, Theravance: Scientific Advisor, Consulting fee R. V. Nathan, Merck: Speaker’s Bureau, Speaker honorarium Allergan: Speaker’s Bureau, Speaker honorarium The Medicines Company: Speaker’s Bureau, Speaker honorarium K. A. Couch, Merck: Speaker’s Bureau, Speaker honorarium Allergan: Speaker’s Bureau, Speaker honorarium