scholarly journals 195. Economic and Clinical Burden of Respiratory Virus Infections in Allogeneic Hematopoietic Cell Transplantation Recipients

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S226-S226
Author(s):  
Michael G Ison ◽  
Nelson Chao ◽  
Francisco M Marty ◽  
Seung Hyun Moon ◽  
Zhiji Zhang ◽  
...  
Keyword(s):  
Resource Utilization ◽  
Research Study ◽  
Viral Infections ◽  
Scientific Research ◽  
Health Resource ◽  
Health Resource Utilization ◽  
Allogeneic Hct ◽  
Study Investigator ◽  
Respiratory Viral Infections ◽  
One Year

Abstract Background Respiratory viruses (RV), including respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (HMPV), frequently lead to serious complications such as lower respiratory tract infections and death in allogeneic hematopoietic cell transplantation (HCT) recipients. We used a large US claims database to compare the total reimbursement (TR), health resource utilization (HRU) and clinical outcomes between HCT patients with and without RV infections (RVI). Methods We used the Decision Resources Group Real World Evidence Data Repository to identify HCT recipients with date of service for the procedure from 1/1/2012-12/31/2017. We estimated the reimbursements from submitted charges using a reimbursement to charge ratio of 0.425. We examined the study outcomes in the year following HCT in patients with and without RVI. We also used a generalized linear model to determine adjusted TR stratified by the presence or absence of any acute or chronic graft-versus-host diseases (GVHD) after adjusting for age, health plan, underlying disease, stem cell source, number of comorbidities, baseline costs, and follow-up time. Results The study included 13,363 patients, representing 22% of HCTs reported to CIBMTR for the study period, of which 1,368 (10%) were coded with an RVI in the year following HCT: 578 (4%) RSV, 687 (5%) influenza, 166 (1%) PIV, and 181 (1%) HMPV. Unadjusted median TR were $132,395 higher for any RVI ($139,439 RSV, $101,963 influenza, $185,041 PIV and $248,029 HMPV) compared to those without RVI (Table 1). Adjusted TR were significantly higher for patients with any RVI compared to patients without that infection (p< .01) with or without GVHD (Figure 1). Patients with any RVI had significantly longer length of stay (LOS) for the HCT hospitalization, readmission rate and LOS after HCT hospitalization compared to patients without RVI (p< 0.05) (Table 2). A significantly higher proportion of patients with any RVI had pneumonia as compared to patients without that infection, irrespective of presence of GVHD (p< .0001). Table 1: Total healthcare reimbursement within one year of undergoing allogeneic HCT for patients with and without respiratory viral infections Figure 1: Adjusted total reimbursements within one year of undergoing allogeneic HCT for patients with and without respiratory viral infections Table 2: Health resource utilization within one year of undergoing allogeneic HCT for patients with and without respiratory viral infections Conclusion Allogeneic HCT patients with RVI have a significantly higher burden of TR, health resource utilization and worse clinical outcomes such as pneumonia during one year of undergoing HCT, regardless of the presence of GVHD. Disclosures Michael G. Ison, MD MS, AlloVir (Consultant) Francisco M. Marty, MD, Allovir (Consultant)Amplyx (Consultant)Ansun (Scientific Research Study Investigator)Avir (Consultant)Cidara (Scientific Research Study Investigator)F2G (Consultant, Scientific Research Study Investigator)Kyorin (Consultant)Merck (Consultant, Grant/Research Support, Scientific Research Study Investigator)New England Journal of Medicine (Other Financial or Material Support, Honorarium for Video)Regeneron (Consultant, Scientific Research Study Investigator)ReViral (Consultant)Scynexis (Scientific Research Study Investigator)Symbio (Consultant)Takeda (Scientific Research Study Investigator)United Medical (Consultant)WHISCON (Scientific Research Study Investigator) Seung Hyun Moon, MD, MPA, AlloVir (Employee, Shareholder) Zhiji Zhang, MS, AlloVir (Independent Contractor) Aastha Chandak, PhD, AlloVir (Independent Contractor)

scholarly journals 1089. Health Resource Utilization and Costs Associated with Multi-Virus Infection after Allogeneic Hematopoietic Cell Transplantation

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S573-S574
Author(s):  
Joshua A Hill ◽  
Richard T Maziarz ◽  
Seung Hyun Moon ◽  
Aastha Chandak ◽  
Zhiji Zhang ◽  
...  
Keyword(s):  
Research Study ◽  
Viral Infections ◽  
Scientific Research ◽  
Panel Member ◽  
First Year ◽  
Health Resource ◽  
Research Support ◽  
Health Resource Utilization ◽  
Review Panel ◽  
Study Investigator

Abstract Background Reactivation or infection with multiple double-stranded DNA (dsDNA) viruses after allogeneic hematopoietic cell transplant (allo-HCT) has been associated with increased morbidity in single center studies. We used a large US claims database to compare health care reimbursements and health resource utilization (HRU) between allo-HCT patients with no versus multiple infections due to CMV, BKV, EBV, JCV, AdV, and HHV-6. Methods We used the Decision Resources Group Real World Evidence Data Repository to identify allo-HCT recipients from 1/1/12-12/31/17. We grouped BKV, EBV and JCV due to lack of specific diagnosis codes and calculated reimbursements from submitted charges using a reimbursement to charge ratio of 0.425. We describe reimbursements and HRU in the 1-year post allo-HCT for patients with 1 vs. 2 vs. ≥ 3 vs. no dsDNA viral infections. We also used a generalized linear model to determine reimbursements stratified by the presence or absence of any acute or chronic graft-versus-host diseases (GVHD) after adjusting for age, health plan, underlying disease, stem cell source, baseline costs, and follow-up time. Results Among the 13,363 allo-HCT patients, 3,878 (29%) were coded with CMV, 1,754 (13%) with BKV/EBV/JCV, 626 (5%) with AdV, and 561 (4%) with HHV-6. Further, 3,949 (30%) were coded with 1 virus, 1,069 (8%) with 2, 238 (2%) with ≥3, and 8,107 (61%) with none. The unadjusted mean reimbursements per patient group were: 1 virus, $431,614; 2, $639,097; ≥3, $964,378; none, $266,345 (Table 1). Adjusted reimbursements were significantly higher for each additional viral infection among patients with and without GVHD compared to patients with no viral infections (p< .0001) (Figure 1). HRU also increased as the number of viral infections increased. Patients with multiple viruses had longer lengths of stay (up to 2.5 weeks for index, 5 weeks for readmissions), ICU days (up to 1.5 weeks for index and readmissions) and higher readmission rates (up to 3 times) (Table 1). Table 1: Economic burden and health resource utilization in the first year after allo-HCT, stratified by number of dsDNA viral infections Figure 1: Adjusted total reimbursements in the first year after allo-HCT, stratified by number of dsDNA viral infections and GVHD Conclusion Allo-HCT patients with multiple dsDNA viral infections have significantly higher health care costs and HRU in the first year after allo-HCT, irrespective of the presence of GVHD. Improved dsDNA virus prevention strategies may reduce costs and improve outcomes. Disclosures Joshua A. Hill, MD, Allogene (Consultant)Allovir (Consultant)Gilead (Consultant)Karius (Grant/Research Support, Scientific Research Study Investigator)Takeda (Grant/Research Support, Scientific Research Study Investigator) Richard T. Maziarz, MD, AlloVir (Consultant)Artiva Biotherapeutics (Board Member)Athersys (Advisor or Review Panel member)BMS/ Celgene (Consultant, Grant/Research Support, Scientific Research Study Investigator)CRSPR (Consultant, Scientific Research Study Investigator)Fate Therapeutics (Scientific Research Study Investigator)Incyte (Consultant, Scientific Research Study Investigator)Kite Therapeutics (Consultant)Novartis (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support)Omeros (Consultant, Grant/Research Support)PACT Pharma (Consultant) Seung Hyun Moon, MD, MPA, AlloVir (Employee, Shareholder) Aastha Chandak, PhD, AlloVir (Independent Contractor) Zhiji Zhang, MS, AlloVir (Independent Contractor) Michael Boeckh, MD PhD, AlloVir (Consultant)EvrysBio (Advisor or Review Panel member, Other Financial or Material Support, share options)Gilead (Consultant, Grant/Research Support)GSK (Consultant)Helocyte (Advisor or Review Panel member, Shareholder)Lophius (Grant/Research Support)Merck (Consultant, Grant/Research Support)SymBio (Consultant)VirBio (Consultant, Grant/Research Support)

scholarly journals 254. Excellent Outcomes with Oral Versus Intravenous Antibiotics for Bone and Joint Infections: A Single-Center Experience

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S233-S234
Author(s):  
Amanda Lang ◽  
Jacey L Hilbers ◽  
Mason Halouska ◽  
Zachary A Van Roy ◽  
Angela Hewlett ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Research Study ◽  
Joint Infection ◽  
Vertebral Osteomyelitis ◽  
Scientific Research ◽  
Joint Infections ◽  
Study Investigator ◽  
Bone And Joint Infections ◽  
Common Diagnosis ◽  
One Year

Abstract Background The OVIVA trial, published in 2019, demonstrated equivalent efficacy of oral (PO) versus intravenous (IV) antibiotics for bone and joint infections. We report our group’s one-year outcomes in a cohort of such patients who received PO or IV antibiotics. Methods Our orthopedic surgery and orthopedic infectious diseases (ID) groups agreed to employ early switch to PO in patients with a first episode of non-vertebral osteomyelitis (OM), native or prosthetic joint infection (NJA or PJI), or hardware infections when a pathogen susceptible to highly bioavailable antibiotics had been identified and the patient was perceived to be at low risk for medication non-adherence. We reviewed patients 19+ years old seen in the Ortho ID clinic for one of these conditions from July 1st through December 31st, 2019. Data recorded included patient demographics and comorbidities, infection type and site, microbiology, and surgical and antibiotic management. Primary outcome was treatment failure at 1 year, defined as death, unplanned surgery at same site, or chronic antibiotic suppression. Results Forty patients (all IV antibiotics, n=17; initial or switch to PO, n=23) were included. Median IV duration was 15 days. PJI was the most common diagnosis (n=22), followed by other hardware infection and OM (n=7 each). Of the PJIs, 13/22 were managed with 2-stage exchange and 11/13 of these received all-IV therapy. Of the hardware infections, 4/7 underwent debridement and retention or single-stage exchange and all of these received initial or switch to PO therapy. Staphylococci (n=14 S. aureus and n=7 coagulase-negative) and streptococci (n=12) were the most common pathogens. Amoxicillin (n=8), trimethoprim-sulfa (n=6), and levofloxacin (n=3) were the most-used PO antibiotics. The PO group received longer treatment (mean 67 vs 48 days). No treatment failures occurred in the patients who started or switch to PO antibiotics, whereas 35% of patients who received all-IV therapy experienced failure. Conclusion Adopting known risk factors for poor outcome in bone and joint infection such as prior treatment failure and no identified pathogen as exclusion criteria for early switch to PO antibiotic therapy led to excellent one-year treatment outcomes across a range of musculoskeletal infections. Disclosures Angela Hewlett, MD, MS, Mapp Biopharmaceutical (Scientific Research Study Investigator) Angela Hewlett, MD, MS, Mapp Biopharmaceutical, Inc (Individual(s) Involved: Self): Scientific Research Study Investigator Nicolas W. Cortes-Penfield, MD, Nothing to disclose

scholarly journals 100. Safety Analysis of Live-Attenuated Measles, Mumps, Rubella Vaccine Among Hematopoietic Cell Transplant Recipients Vaccinated Within Two Years of Transplant

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S63-S63
Author(s):  
Xhoi Mitre ◽  
Monica Feeley ◽  
Amy C Sherman ◽  
Stephen R Walsh ◽  
Matthew Cheng ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
Panel Member ◽  
Cell Transplant ◽  
Mmr Vaccine ◽  
Hematopoietic Cell Transplant ◽  
Review Panel ◽  
Allogeneic Hct ◽  
Study Investigator ◽  
Measles Outbreak

Abstract Background Measles, mumps and rubella (MMR) vaccine is a live-attenuated vaccine usually contraindicated within the first two years of hematopoietic cell transplant (HCT). During the 2019 measles outbreak at our center, the benefits of administering MMR vaccine within the first two years after HCT were weighed against the potential risks. Methods We conducted a retrospective review of patients who received MMR vaccination within two years of an autologous or allogeneic HCT. Patients’ demographics, date and type of HCT, underlying hematologic disease, type of immunosuppressive therapy and date of MMR vaccination were extracted from the electronic medical record. Adverse reactions that could be related to the vaccine were collected for up to 42 days post-vaccination and all hospitalizations and deaths following vaccination were reviewed. Results A total of 129 patients (75 autologous and 54 allogeneic HCT) were vaccinated between 300-729 days after HCT (median of 718 days). The median age at vaccination was 61 years old, 57% of the patients were male and 43% were on immunosuppressive therapy, 87% of whom were on maintenance therapy for multiple myeloma after auto-HCT. Seven patients (5%) had adverse reactions within 42 days of vaccination: six had respiratory tract infections (three with associated fever) and one had a rash leading to a brief hospitalization. This was a 37-year-old female who had an allogeneic HCT 542 days prior to MMR vaccination. She presented with a centrifugal maculopapular rash that was confirmed to be caused by the vaccine strain rubella virus (Fig 1). She fully recovered without sequalae. There was no other vaccine-associated illness identified in the cohort, after a median follow-up of 676 days. Conclusion MMR vaccine appears to be well tolerated in selected HCT recipients when given earlier than 2 years after transplant. No attributable severe outcomes or deaths were described. A mild uncomplicated case of vaccine-associated rubella illness was seen after vaccination. In the setting of a measles outbreak, assessment of potential risks and benefits of MMR vaccination given within two years of HCT remains important. Disclosures Stephen R. Walsh, MDCM, Janssen Vaccines (Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator)Sanofi Pasteur (Scientific Research Study Investigator) Matthew Cheng, MD, GEn1E Lifesciences (Advisor or Review Panel member)Kanvas Biosciences (Board Member, Shareholder)nplex biosciences (Advisor or Review Panel member) Sanjat Kanjilal, MD, MPH, GlaskoSmithKline (Advisor or Review Panel member) Nicolas C. Issa, MD, AiCuris (Scientific Research Study Investigator)Astellas (Scientific Research Study Investigator)GSK (Scientific Research Study Investigator)Merck (Scientific Research Study Investigator)

Abstract 17250: Ranolazine Use Following Initial Anti-anginal Therapy Is Associated With Lower Health Resource Utilization Among U.S. Veterans With Chronic Stable Angina

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Adam Bress ◽  
John Dodson ◽  
Brian Sauer ◽  
Scott DuVall ◽  
Jacob Crook ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Resource Utilization ◽  
Stable Angina ◽  
Bypass Graft ◽  
Chronic Stable Angina ◽  
Health Resource ◽  
Health Resource Utilization ◽  
Historical Cohort ◽  
Treatment Groups ◽  
One Year

Introduction: While clinical trials show improvement in angina symptoms with ranolazine, it is unclear whether this improvement translates into reduced health resource utilization (HRU). We, therefore, sought to analyze whether HRU declined at one year after ranolazine initiation within a large integrated health system. Methods: This was a historical cohort study using nationwide Department of Veterans Affairs (VA) data. We compared participants with a diagnosis of coronary artery disease and chronic stable angina who were prescribed ranolazine, as monotherapy or add-on, following an initial trial of ≥ 1 anti-anginal agent versus alternative secondary agents between 01/01/2006 and 12/31/2013. We addressed confounding through inverse probability (IP) of treatment weighting. We used IP-weighted regression models to evaluate adjusted risk ratios and incident rate ratios for coronary revascularizations, hospitalizations, emergency room (ER) visits, and costs within one year. Results: Of 37,060 patients identified, IP weighted treatment groups comprised 4,766 patients prescribed ranolazine and 32,261 prescribed an alternative agent as their second or third anti-anginal. There were no significant differences in baseline characteristics between treatment groups after IP weighting. In the IP-weighted outcome analysis, coronary artery bypass graft surgeries were significantly lower with ranolazine. All-cause, atrial fibrillation (AF) and heart failure (HF) specific hospitalizations, and total costs were significantly lower in the ranolazine group. Conclusions: Among patients with CSA prescribed a second or third anti-anginal pharmacotherapy, ranolazine was associated with fewer all-cause hospitalizations, hospitalizations for AF and HF, ER visits and total costs. These findings suggest that the reduction in angina symptoms seen in other studies of ranolazine may translate into lower HRU compared to conventional pharmacotherapies.

scholarly journals 1506. Burden of Respiratory Syncytial Virus (RSV) and Other Lower Respiratory Tract Viral Infections During the First Two Years of Life: a Prospective Study

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S756-S756
Author(s):  
Shabir A Madhi ◽  
Ana Ceballos ◽  
Jo Ann Colas ◽  
Luis Cousin ◽  
Ulises D’Andrea ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nasal Swab ◽  
Research Study ◽  
Viral Infections ◽  
Scientific Research ◽  
Human Clinical Trial ◽  
Research Support ◽  
Material Support ◽  
Study Investigator ◽  
Research Grant

Abstract Background Lower respiratory tract infections (LRTIs) are a leading cause of pediatric morbidity and mortality worldwide, with ~650,000 deaths recorded in < 5-year-olds in 2016. Cross-sectional studies on hospitalized LRTIs are available, but longitudinal studies on the total burden of viral LRTIs are scarce. This study (NCT01995175) prospectively collected incident RSV and other viral LRTIs in a multinational cohort. Methods From 2013 to 2017, infants in 8 countries were enrolled at birth and followed for LRTIs up to 2 years of age. Infants with suspected LRTIs were clinically examined and swabbed. Nasal swab samples were tested using quantitative real-time PCR for RSV and multiplex PCR panel for 16 other respiratory viruses/subtypes; bacterial culture was not performed. LRTI and severe LRTI episodes were defined per 2015 WHO LRTI case definitions. Viruses detected from nasal swabs collected from participants with WHO-defined LRTI and severe LRTI episodes are reported. Results The 2401 infants followed experienced 1012 LRTI episodes; 259 of these were severe LRTIs. At least 1 virus was detected from 909 (90%) and 235 (91%) LRTI and severe LRTI episodes, respectively. Enteroviruses/Rhinoviruses (EV/RV, 49%) were detected most frequently in samples collected from LRTI episodes, followed by RSV (22%), parainfluenza (PIV, 14%), human metapneumovirus (hMPV, 8%) and seasonal coronavirus (CoV, 6%). RSV was detected in 39% of samples from LRTI episodes in < 3-month-olds and in 18% of 1-year-olds (Table 1). In a similar trend, RSV was detected in 47% of samples from severe LRTI episodes in < 3-month-olds and in 21% of 1-year-olds (Table 2). Co-infection with another virus was common in CoV-positive samples (67%), while most samples positive for RSV (71%), hMPV (70%), EV/RV (67%) and PIV (58%) had no other virus detected. Table 1. Occurrence of laboratory confirmed respiratory viral infections by viral pathogens identified in nasal swab samples from WHO-defined LRTI episodes Table 2. Occurrence of laboratory confirmed respiratory viral infections by viral pathogens identified in nasal swab samples from WHO-defined severe LRTI episodes Conclusion Respiratory viruses are detected in the majority of LRTIs during the first 2 years of life. RSV likely accounts for much of this overall LRTI burden. Our results suggest that RSV most strongly impacted the very young; it was the most commonly detected virus in severe LRTIs in infants aged < 3 months. RSV was also persistently detected at high levels in samples from LRTIs (22%) and severe LRTIs (28%) in children up to 2 years old. Funding GlaxoSmithKline Biologicals SA Disclosures Ana Ceballos, MD, GSK group of companies (Scientific Research Study Investigator) Jo Ann Colas, MSc, GSK group of companies (Consultant) Luis Cousin, MD, Tecnología en Investigación (Scientific Research Study Investigator) Ilse Dieussaert, IR, GSK group of companies (Employee, Shareholder) Joseph B. Domachowske, MD, Astra Zeneca (Other Financial or Material Support, Grant/Research Support paid to my Institution on my behalf for sponsored human clinical trial activities)GSK group of companies (Other Financial or Material Support, Grant/Research Support paid to my Institution on my behalf for sponsored human clinical trial activities)Merck (Other Financial or Material Support, Grant/Research Support paid to my Institution on my behalf for sponsored human clinical trial activities) Janet A. Englund, MD, AstraZeneca (Scientific Research Study Investigator)GSK group of companies (Scientific Research Study Investigator)Meissa vaccines (Consultant)Merck (Scientific Research Study Investigator)Sanofi Pasteur (Consultant) Sanjay Gandhi, MD, GSK group of companies (Employee) Mélanie Hercor, PhD, GSK group of companies (Employee) Magali de Heusch, PhD, GSK group of companies (Employee) Joanne M. Langley, MD, GSK group of companies (Research Grant or Support)Immunivaccines Inc (Scientific Research Study Investigator, Research Grant or Support)Janssen (Research Grant or Support)Pfizer (Research Grant or Support)Symvivo (Scientific Research Study Investigator, Research Grant or Support)VBI Vaccines (Research Grant or Support) Amanda Leach, MRCPCH, GSK group of companies (Employee) Timo Vesikari, MD, PhD, Denka (Consultant) Sonia K. Stoszek, PhD, GSK group of companies (Employee, Shareholder)

scholarly journals 1157. Clinical Safety, Efficacy, and Pharmacokinetics of Fosmanogepix, a Novel First-in-class Antifungal, in Patients with Renal Insufficiency: Subset Analysis from a Phase 2 Candidemia Trial

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S605-S605
Author(s):  
Pierre Bulpa ◽  
Galia Rahav ◽  
Ilana Oren ◽  
Mickaël Aoun ◽  
George R Thompson ◽  
...  
Keyword(s):  
Renal Function ◽  
Renal Insufficiency ◽  
Antifungal Agents ◽  
Research Study ◽  
Scientific Research ◽  
Panel Member ◽  
Antifungal Treatment ◽  
Successful Outcome ◽  
Review Panel ◽  
Study Investigator

Abstract Background Fosmanogepix (FMGX) is a first-in-class antifungal agent, with a unique MOA targeting the fungal enzyme Gwt1, and broad-spectrum activity against yeasts and molds, including fungi resistant to other antifungal agents. Patients with candidemia often have underlying renal insufficiency or are receiving medications that affect renal function. This analysis evaluated outcomes in patients with varying degrees of renal insufficiency. Methods This global, multicenter, open-label, non-comparative study evaluated the safety and efficacy of FMGX for first-line treatment of candidemia. Patients with a recent diagnosis of candidemia defined as positive blood culture for Candida spp within 96 hrs prior to study entry with ≤ 2 days of prior antifungal treatment were eligible, including those with renal insufficiency. Patients with neutropenia, C. krusei infection, deep-seated Candida infections or receiving hemodialysis were excluded. Subjects were treated with FMGX for up to 14 days: 1000 mg IV BID for 1 day, then 600 mg IV QD for at least 2 days, followed by either 600 mg IV QD or 700 mg PO QD. Patients requiring antifungal treatment beyond 14 days received fluconazole. The primary efficacy endpoint was outcome at end of study treatment (EOST) as determined by an independent data review committee. Successful outcome was defined as survival with clearance of Candida from blood cultures with no additional antifungal treatment. Results 14/21 (66%) subjects had some degree of renal insufficiency: 7 had mild renal insufficiency (GFR:60-89), 5 had moderate renal insufficiency (GFR:30-59), and 2 had severe renal insufficiency (GFR:15-29). 12/14 (86%) completed study treatment, and treatment was successful at EOST in 12/14 (86%) subjects. Decline in renal function was not observed at EOST. 4 had worsening of renal function during the follow-up period; none required dialysis. Renal impairment did not increase exposure of FMGX. There were no treatment-related adverse events. Conclusion FMGX demonstrated high level treatment success with no evidence of drug-related nephrotoxicity, with no dose adjustments required. These preliminary data support the continued evaluation of FMGX in patients with candidemia and renal dysfunction as an alternative to potentially nephrotoxic antifungal agents. Disclosures Pierre Bulpa, MD, Amplyx Pharmaceuticals (Scientific Research Study Investigator) Galia Rahav, MD, AstraZeneca (Scientific Research Study Investigator) Mickaël Aoun, MD, Amplyx Pharmaceuticals (Scientific Research Study Investigator) Peter Pappas, MD, SCYNEXIS, Inc. (Consultant, Advisor or Review Panel member, Research Grant or Support) Bart Jan Kullberg, MD, FRCP, FIDSA, Amplyx (Advisor or Review Panel member) Sara Barbat, BSN, RN, Amplyx Pharmaceuticals (Employee) Pamela Wedel, BSc, Amplyx Pharmaceuticals (Employee) Haran T. Schlamm, MD, Amplyx (Consultant) Michael Hodges, BSc. MD, Amplyx Pharmaceuticals Inc. (Employee)

scholarly journals 1608. Efficacy of Ceftolozane/Tazobactam for Multidrug-Resistant Gram-Negative Infections in Multiple Urban Hospitals

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S798-S799
Author(s):  
Nicolo Cabrera ◽  
Truc T Tran ◽  
Travis J Carlson ◽  
Faris Alnezary ◽  
William R Miller ◽  
...  
Keyword(s):  
Research Study ◽  
Clinical Success ◽  
Significant Proportion ◽  
Scientific Research ◽  
Panel Member ◽  
Multidrug Resistant ◽  
Outcome Data ◽  
Research Support ◽  
Gram Negative ◽  
Study Investigator

Abstract Background Ceftolozane/tazobactam (C/T) is a novel cephalosporin/beta-lactamase inhibitor combination developed for use against multidrug-resistant (MDR) Gram-negative infections, particularly Pseudomonas aeruginosa (PA). C/T is approved for complicated urinary tract and intraabdominal infections as well as hospital-acquired/ventilator-associated bacterial pneumonias. However, comprehensive clinical characterization of patients treated with C/T in non-FDA-approved indications is limited. Methods Patients ≥18 years who received C/T for ≥48 hours while hospitalized in 9 acute care centers in Houston, TX from January 2016 through September 2018 were included. Demographic, microbiologic, treatment and clinical outcome data were retrospectively collected by chart review. In patients who received multiple inpatient courses of C/T, only the first course with C/T was assessed. Results 210 patients met inclusion criteria: 58% were non-white, 35% were female and 13% were immunocompromised. Median age was 61 years (IQR, 48 to 69). Median Charlson comorbidity index was 5 (IQR, 2 to 6). At the onset of the index episode, a significant proportion of patients required intensive care unit admission (44%), mechanical ventilation (37%) and pressor support (22%). Respiratory sources were the most common (50%) followed by urine (15%). Positive cultures were documented in 93% of the cases and PA was found in 86%. Majority (95%) of PA which were MDR. C/T use was guided by susceptibility testing of the index isolate in ca. 52%. In 5.7% of cases, C/T was used to escalate therapy without any documented C/T-susceptible organism. Half (51%) of the cohort received initial dosing appropriate for renal function while 36% receiving a lower than recommended dose. Clinical success (i.e., recovery from infection-related signs and symptoms) occured in 77%. The in-hospital mortality rate in our cohort was 15% with 26 of 31 deaths deemed infection-related. Conclusion We report a large multicenter observational cohort that received C/T. A 77% clinical success with the use of C/T was documented. These data support the use of C/T in critically ill patients infected with MDR PA. Disclosures William R. Miller, MD, Entasis Therapeutics (Scientific Research Study Investigator)Merck (Grant/Research Support)Shionogi (Advisor or Review Panel member) Laura A. Puzniak, PhD, Merck (Employee) Cesar A. Arias, MD, MSc, PhD, FIDSA, Entasis Therapeutics (Scientific Research Study Investigator)MeMed (Scientific Research Study Investigator)Merck (Grant/Research Support)

scholarly journals 1393. Factors Associated with Co-administration of Pentavalent DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United States (US)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S706-S706
Author(s):  
Tanaz Petigara ◽  
Ya-Ting Chen ◽  
Zhiwen Liu ◽  
Michelle Goveia ◽  
David Johnson ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
The United States ◽  
Vaccination Schedule ◽  
Provider Type ◽  
Factors Associated ◽  
Study Investigator ◽  
Region Of Residence ◽  
Birth Dose ◽  
To Receive

Abstract Background The US vaccination schedule includes DTaP, IPV, Hib and HepB doses in the first 6 months of life. A previous analysis found variability in the timing of HepB doses in infants receiving DTaP-IPV/Hib. We explored factors associated with co-administration of DTaP-IPV/Hib and HepB on the same day. Methods This was a retrospective study using the MarketScan® commercial claims and encounters database. Infants born from 1 July 2010 - 30 June 2016, continuously enrolled in an insurance plan for ≥ 13 months and receiving ≥ 3 DTaP-IPV/Hib doses were included. Infants were assessed for HepB claims relative to the first and third DTaP-IPV/Hib doses. Because a HepB birth dose was assumed, the first HepB claim from 29 - 169 days following birth was counted as Dose 2, and the second claim from 170 days - 12 months as Dose 3. Associations between demographic, provider, and insurance characteristics, receipt of other pediatric vaccines, and co-administration of DTaP-IPV/Hib and HepB were analyzed using multivariate logistic regression. Results Among 165,553 infants who received a first DTaP-IPV/Hib dose, 60.7% received HepB Dose 2 on the same day. Among 162,217 infants who received a third DTaP-IPV/Hib dose, 45.1% received HepB Dose 3 on the same day. Infants in the Northeast were less likely (OR=0.38, 95%CI=0.36-0.39), while those in the West were more likely (OR=1.41, 95%CI=1.36-1.46) than infants in the South to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day. Infants vaccinated by pediatricians (OR=0.54, 95%CI=0.53-0.55) were less likely to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day compared to infants vaccinated by family physicians. Infants who received PCV on the same day as the first dose of DTaP-IPV/Hib were more likely to receive HepB Dose 2 (OR=6.96, 95%CI=6.30-7.70) that day. These factors were also associated with co-administration of the third dose of DTaP-IPV/Hib and HepB Dose 3. Conclusion Differences in co-administration of DTaP-IPV/Hib and HepB were associated with region of residence, provider type and co-administration of PCV. The reasons underlying these differences merit exploration. A hexavalent vaccine containing DTaP, IPV, Hib, and HepB could improve timeliness of HepB vaccination, while reducing the number of injections during infancy. Disclosures Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Zhiwen Liu, PhD, Merck & Co., Inc., (Employee) Michelle Goveia, MD, Merck & Co., Inc (Employee, Shareholder) David Johnson, MD, MPH, Sanofi Pasteur (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator)

scholarly journals 673. Updated CLSI Ciprofloxacin Breakpoints from a Multicenter Assessment for Enterobacterales, Salmonella spp. and Pseudomonas aeruginosa Using MicroScan Dried Gram Negative MIC Panels

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S391-S391
Author(s):  
Maria M Traczewski ◽  
Denise Beasley ◽  
Amanda Harrington ◽  
Sharon DesJarlais ◽  
Omai Garner ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
Reference Panel ◽  
Broth Microdilution ◽  
Salmonella Spp ◽  
Research Personnel ◽  
Gram Negative ◽  
Material Support ◽  
Study Investigator ◽  
Support Research

Abstract Background Updated US FDA/CLSI ciprofloxacin breakpoints were evaluated against data from a multicenter clinical study with Enterobacterales, Salmonella spp. and P. aeruginosa on a MicroScan Dried Gram-negative MIC (MSDGN) Panel. MIC results were compared to results obtained with frozen broth microdilution panels prepared according to CLSI methodology. Methods MSDGN panels were evaluated at three clinical sites by comparing MIC values obtained using the MSDGN panels to MICs utilizing a CLSI broth microdilution reference panel. Data from the combined phases of efficacy and challenge included 803 Enterobacterales, Salmonella spp. and P. aeruginosa clinical isolates tested using the turbidity and Prompt® methods of inoculation. To demonstrate reproducibility, a subset of 12 organisms were tested on MSDGN panels at each site during reproducibility. MSDGN panels were incubated at 35 ± 1ºC and read on the WalkAway System, the autoSCAN-4 instrument, and visually. Read times for the MSDGN panels were at 16-20 hours. Frozen reference panels were prepared and read according to CLSI methodology. FDA and CLSI breakpoints (µg/mL) used for interpretation of MIC results were: Enterobacterales ≤ 0.25 S, 0.5 I, ≥ 1 R; Salmonella spp. ≤ 0.06 S, 0.12-0.5 I, ≥ 1 R; P. aeruginosa ≤ 0.5 S, 1 I, ≥ 2 R. Results Essential and categorical agreement was calculated compared to frozen reference panel results. Results for isolates tested during efficacy and challenge with Prompt inoculation and manual read are as follows: Conclusion Ciprofloxacin MIC results for Enterobacterales, Salmonella spp., and P. aeruginosa obtained with the MSDGN panel correlate well with MICs obtained using frozen reference panels using updated FDA/CLSI interpretive criteria in this multicenter study. * PROMPT® is a registered trademark of 3M Company, St. Paul, MN USA. BEC, the stylized logo and the BEC product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the US and other countries. Disclosures Maria M. Traczewski, BS MT (ASCP), Beckman Coulter (Scientific Research Study Investigator) Denise Beasley, BS, Beckman Coulter (Other Financial or Material Support, Research personnel) Amanda Harrington, PhD, Beckman Coulter (Scientific Research Study Investigator) Sharon DesJarlais, BS, Beckman Coulter (Other Financial or Material Support, Research personnel) Omai Garner, PhD, D(ABMM), Beckman Coulter (Scientific Research Study Investigator) Christine Hastey, PhD, Beckman Coulter (Employee) Regina Brookman, BS, Beckman Coulter (Employee) Zabrina Lockett, MS, Beckman Coulter (Employee) Jennifer Chau, PhD, Beckman Coulter (Employee)

scholarly journals 1400. Physician Attitudes towards Combination Vaccine Use in Infants up to 24 months of age in the United States (US)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S708-S709
Author(s):  
Ya-Ting Chen ◽  
Xinyi Ng ◽  
Tanaz Petigara ◽  
Jyoti Aggarwal ◽  
Jenna Bhaloo ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
Physician Attitudes ◽  
Combination Vaccine ◽  
Hexavalent Vaccine ◽  
Family Practitioners ◽  
Study Investigator ◽  
Vaccine Schedule ◽  
Combination Vaccines ◽  
Number Of Injections

Abstract Background Combination vaccines reduce the number of injections and improve the timeliness of vaccination coverage. US Advisory Committee on Immunization Practices (ACIP) recommendations state that combination vaccines are generally preferred over equivalent individual component vaccines. Healthcare providers strongly influence parental decisions about vaccination. We sought a contemporary understanding of physician’s attitudes towards combination vaccine use in infants. Methods We conducted an online survey of US physicians (70 pediatricians and 30 family practitioners) who administer vaccines to infants aged 0-24 months and spend at least 2 days a week providing patient care. Information was collected on attitudes towards combination vaccines and factors that influence the choice of combination vaccine used in clinical practice. Descriptive analyses were performed. Results Physicians (mean age=50.2 years, range 30.0-70.0; 66% white; 37% women) reported a median of 4 injections (range 2-9) as the maximum that parents would accept at a single visit, and 71% routinely explained what combination vaccines are to parents. When deciding which pentavalent vaccine to use, physicians considered how the brand fits into the current vaccine schedule (71%); upfront purchase costs (64%); and availability as a prefilled syringe (61%). The main reasons for using combination vaccines were to reduce the number of injections (96%); ensure the infant is up-to-date with vaccinations (86%); and reduce the pain that the infant experiences with multiple injections (68%). More than half reported that their institution or practice has a program to incentivize infant vaccination according to schedule. If a hexavalent vaccine-based schedule was available, 76% of physicians said they would choose it over their current schedule comprising pentavalent or equivalent component vaccines. Conclusion Choice of pentavalent combination vaccine among pediatricians and family practitioners was largely dependent on convenience and cost-related factors. Over three-quarters would be inclined to use a hexavalent vaccine schedule if available. Disclosures Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Xinyi Ng, PhD, Merck & Co., Inc. (Consultant) Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder) Jyoti Aggarwal, MHS, Merck & Co., Inc. (Consultant) Jenna Bhaloo, MPH, Merck & Co., Inc. (Consultant) Michelle Goveia, MD, Merck & Co., Inc (Employee, Shareholder) David Johnson, MD, MPH, Sanofi Pasteur (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator)

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