Impact of a cefepime shortage on dosing regimens and outcomes in hospitalized adults with febrile neutropenia

2020 ◽  
pp. 107815522091863
Author(s):  
Manuela Haiduc ◽  
Monank Patel ◽  
Thomas L Walsh ◽  
Matthew A Moffa ◽  
Derek N Bremmer

Background Drug shortages may negatively impact outcomes in hospitalized patients. A cefepime dosing regimen of 1 gram every 6 hours (1 g q6h) has shown to provide similar exposures above target minimum inhibitory concentrations compared to the regimen of 2 g q8h approved by the United States Food and Drug Administration (FDA) for febrile neutropenia. Our objective was to determine if the dosing regimen of 1 g q6h amidst a cefepime shortage is an appropriate alternative for the treatment of febrile neutropenia. Methods A retrospective chart review of hospitalized patients who received cefepime for febrile neutropenia over a two-year period was performed. Patients were grouped based on cefepime dosing strategy: 2 g q8h vs. 1 g q6h. The primary objective was to compare time to defervescence after cefepime initiation. Secondary objectives included all-cause 30-day mortality, duration of antibiotic therapy, and inpatient length of stay. Results Seventy-five patients in each arm were included. There were no differences in baseline age or severity of illness between groups. There was no difference in the primary objective as median time to defervescence was similar between the 2 g q8h and 1 g q6h groups (69.0 vs. 65.3 h: p= 0.67). Additionally, no differences were found in the secondary objectives of all-cause 30-day mortality (10.7% vs. 9.3%: p = 0.79), duration of therapy (80.8 vs. 88.0 h: p = 0.34), or length of stay (9 vs. 7 days: p = 0.50). Conclusions Our study identified no differences in clinical outcomes with cefepime 1 g q6h compared to the traditional FDA-approved 2 g q8h regimen for the treatment of febrile neutropenia.

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S816-S816
Author(s):  
Travis Denmeade ◽  
William Smith ◽  
Banks Kooken ◽  
Michael Leonard

Abstract Background The US has seen a rise in the proportion of patients with extrapulmonary tuberculosis (TB) even though the yearly incidence of new TB cases has been in decline. The purpose of this study was to analyze incidence of extrapulmonary TB at Atrium Health, a large non-profit health system in the Southeastern US. Methods Retrospective chart review of 94 adult patients with culture confirmed extrapulmonary TB between 2008-2019. Individuals younger than 18 years were excluded from analysis. The primary objective was to examine incidence of extrapulmonary TB and compare it to that reported in the literature. Secondary objectives included determination of sites of extrapulmonary disease and associated patient characteristics including HIV status, race, ethnicity, and birthplace. Results 237 patients were identified as having confirmed TB infection from 2008-2019 in a retrospective analysis within the Atrium Health System. 94 (40%) were found to have extrapulmonary disease; 42 (45%) with concomitant pulmonary disease. The patients were 55% male, 40% African American, 21% Hispanic or Latino, and 51% US-born. Median age was 44 years (range 20-62). The most common sites of extrapulmonary TB were lymphatic (35%), pleural (24%), GI/Peritoneal (12%), CNS (10%), and Bone/Joint (10%). Lymphatic involvement was 40% cervical, 19% intrathoracic, and 16% axillary. 66% of skeletal disease was vertebral. Other sites included GU, pericardial, skin, and disseminated disease (5%). 37% were HIV positive, 18% with unknown HIV status as they were never tested. Information regarding patient’s race, ethnicity, and birthplace were unknown for 2 patients. The percentage of extrapulmonary cases were 29% in 2008, 39% in 2012, 38% in 2016, and 49% in 2019. Conclusion Lymphatic and pleural involvement were the most common extrapulmonary sites. Of those tested, 37% were HIV positive but there was a significant portion never tested showing a need for increased testing. The proportion of extrapulmonary TB cases since 2008 is higher at 40% compared to the 31% reported in the United States. There has been a rise in the proportion of extrapulmonary TB within our healthcare system and deserves further analysis. Disclosures All Authors: No reported disclosures


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2404-2404
Author(s):  
Arya Mariam Roy ◽  
Manojna Konda ◽  
Akshay Goel ◽  
Appalanaidu Sasapu

Introduction Disseminated Intravascular Coagulation (DIC) is a systemic coagulopathy which leads to widespread thrombosis and hemorrhage and ultimately results in multiorgan dysfunction. DIC usually occurs as a complication of illnesses like severe sepsis, malignancies, trauma, acute pancreatitis, burns, and obstetrical complications. The prognosis and mortality of DIC depend on the etiology, however, the mortality of DIC is known to be on the higher side. The aim of the study is to analyze if gender, race, regional differences have any association with the mortality of hospitalized patients with DIC. Method The National Inpatient Sample database from the Healthcare Cost and Utilization Project (HCUP) for the year 2016 was queried for data. We identified hospital admissions for DIC with the International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code D65. The data was analyzed with STATA 16.0 version and univariate and multivariate analysis were performed. We studied the characteristics of all such hospitalizations for the year 2016 and the factors associated with the in-hospital mortality rate (MR) of DIC. We used length of stay, cost of stay as an outcome to determine if gender, race, and location play a role in the mortality. Results A total of 8704 admissions were identified with a diagnosis of DIC during the year 2016. The mean age for admission was found to be 56.48± 0.22. The percentage of admissions in females and males did not have a notable difference (50.57% vs 49.43%). The disease specific MR for DIC was 47.7%. Admission during weekend vs weekdays did not carry a statistically significant difference in terms of MR. Females with DIC were less likely to die in the hospital when compared to males with DIC (OR= 0.906, CI 0.82 - 0.99, p= 0.031). Interestingly, African Americans (AA) with DIC admissions were found to have 24% more risk of dying when compared to Caucasians admitted with DIC (OR= 1.24, CI 1.10 - 1.39, P= 0.00), Native Americans (NA) has 67% more risk of dying when compared to Caucasians (OR= 1.67, CI 1.03 - 2.69, p= 0.035). The mortality rate of NA, AA, Caucasians with DIC was found to be 57%, 52%, 47% respectively. The MR was found to be highest in hospitals of the northeast region (52%), then hospitals in the south (47%), followed by west and mid-west (46%), p= 0.000. Patients admitted to west and mid-west were 24% less likely to die when compared to patients admitted to northeast region hospitals (OR= 0.76, p= 0.001). The average length of stay and cost of stay were also less in west and mid-west regions when compared to north east. The difference in outcomes persisted after adjusting for age, gender, race, hospital division, co-morbid conditions. Conclusion Our study demonstrated that African Americans and Native Americans with DIC have high risk of dying in the hospital. Also, there exists a difference between the mortality rate, length and cost of stay among different regions in the United States. More research is needed to elucidate the factors that might be impacting the location-based variation in mortality. Disclosures No relevant conflicts of interest to declare.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A861-A861
Author(s):  
Chukwuka Akamnonu ◽  
David A Cohen

Abstract Introduction: Current guidelines from the International Society of Thrombosis and Hemostasis recommend limited screenings for deep vein thrombosis (DVT) or pulmonary embolism (PE) with no identifiable precipitating factor (termed unprovoked). There is paucity of data with regards to thyroid cancer screening in the setting of an unprovoked VTE. Studies from Europe have shown an association between VTE and thyroid cancer; however, these studies do not account for differences in iodine availability, thus the need for studies in the United States. Understanding the risk of thyroid cancer as a provocative factor in developing a deep venous thrombosis (DVT) or pulmonary embolism (PE) may be able to facilitate case detection of disease and prevent future morbidity and mortality from thyroid cancer and/or VTE. Objectives: The primary objective of this study is to understand the risk of developing VTE in the setting of thyroid cancer. Methods: In this retrospective chart review study, we reviewed electronic medical records of patients with a history of DVT or PE between ages 18-99, presenting to all outpatient clinics at a single academic medical center in New Jersey between October 1, 2015, and Dec 31, 2018. We screened for coexistent cancer history among this group, and from this sample we further isolated cases of thyroid cancer. Results: 345 patients were found to have a history of VTE. 187 were female (54%) and 113 (29%) had a history of malignancy. The most common cancers were breast (19%), colorectal (9%), leukemia (9%), prostate (8%), and lymphoma (8%). Thyroid cancer accounted for 2% of all discovered cases. Conclusion: In this retrospective analysis, 2% of all patients with VTE and cancer carried a diagnosis of thyroid cancer. Although this suggests a relatively low risk, given the medical burden of a venous thromboembolism and the comparable proportion of thyroid cancer in all new cancer cases, thyroid cancer should be considered a provoking factor in unprovoked VTE.


2016 ◽  
Author(s):  
Lindsay Mook

<p>Despite advances in the diagnosis and treatment of Clostridium difficile infection (CDI), the prevention of CDI, particularly in the inpatient hospital setting, remains a challenge. Clostridium difficile now rivals methicillin-resistant staphylococcus aureus (MRSA) as the most common pathogen to cause hospital acquired infections (HAI) in the United States. Hospitalized patients are considered to be especially high risk for CDI, and among inpatient cases, antibiotic treatment, especially with Fluoroquinolones has been an almost universal factor in the development of CDIs. One preventative measure that is incontinently used in the prevention of CDI is oral probiotics. Probiotic consumption is reported to exert a myriad of beneficial effects including enhanced immune response, balancing of colonic microbiota, treatment of diarrhea associated with travel and antibiotic therapy, control of rotavirus and clostridium difficile induced colitis. The American College of Gastroenterology recognizes the role of probiotics and included probiotics as a level B recommendation for the treatment of CDI. It has been hypothesized that the use of probiotics, as an adjunctive therapy in patients receiving antibiotics, may provide a key intervention in reducing primary CDI. The purpose of this study was to conduct a retrospective chart review to explore healthcare providers prescribing trends regarding Fluoroquinolone antibiotics and adjunctive probiotics in patients with hospital acquired CDI. The Synergy model was used to guide the study. Results indicated that probiotics are not frequently prescribed for hospitalized patients on Fluoroquinolones and when they are it is with inconsistency. Additional research is recommended to further assess the use of probiotics in conjunction with other classes of commonly used antibiotics; this study solely looked at Fluoroquinolones.</p>


2020 ◽  
Author(s):  
Lisa R Treviño ◽  
Kristina Vatcheva ◽  
Michael E Auer ◽  
Angela Morales ◽  
Lama M Abdurrahman ◽  
...  

Abstract Background Traumatic brain injury (TBI) is one of the leading causes of disability in the United States. The EKSO GT Bionics® (EKSO®) is a robotic exoskeleton approved by the Federal Drug Administration (FDA) for rehabilitation following a cerebrovascular accident (CVA or stroke) and recently received approval for use in patients with TBI. The aim of the study was to examine if the use of exoskeleton rehabilitation in patients with TBI will produce beneficial outcomes. Methods This retrospective chart-review reports the use of the (EKSO®) robotic device in the rehabilitation of patients with TBI compared to patients with CVA. We utilized data from a single, private rehabilitation hospital for patients that received post-CVA or post-TBI robotic exoskeleton intervention. All patients that used the exoskeleton were discharged from the hospital between 01/01/2017 to 04/30/2020. Ninety-four percent of patients in the CVA groups and 100% of patients in the TBI group were of Hispanic or Latino ethnicity. Gains in total Functional Independence Measure (FIM), walking and cognition, and length of stay in the rehabilitation facility were measured. Results Patients in the TBI group (n = 11) were significantly younger than the patients in the CVA group (n = 66; p < 0.05). Both groups spent a similar amount of time active, number of steps taken, and the number of sessions in the exoskeleton. Both groups also started with similar admission FIM scores. The FIM gain in the TBI group was similar to that of the CVA group (37.5 and 32.0 respectively). The length of stay between groups was not different either. Conclusions The use of exoskeleton rehabilitation in patients with TBI appear to produce similar outcomes as for patients with CVA, prompting further attention of this intervention for this type of injury. Trial registration: Retrospectively registered on 07/09/2020 in clinicaltrials.gov number NCT4465019.


2021 ◽  
Vol 09 (06) ◽  
pp. E927-E933
Author(s):  
Aleksey A. Novikov ◽  
Jennifer H. Fieber ◽  
Monica Saumoy ◽  
Russell Rosenblatt ◽  
Shirley A. Cohen Mekelburg ◽  
...  

Abstract Background and study aims Acute pancreatitis (AP) is an increasingly common indication for hospitalization in the United States. The necessity for endoscopic retrograde cholangiopancreatography (ERCP) and the timing of ERCP in acute gallstone-related pancreatitis without cholangitis (AGPNC) is controversial. The aim of this study was to evaluate the association of ERCP and its performance during admission with mortality and length of stay (LOS) in patients with AGPNC. Patients and methods We queried the Nationwide Inpatient Sample (NIS) from 2004 to 2014 to identify all patients with admissions for gallstone AP. We excluded patients with chronic pancreatitis or concurrent cholangitis, and those who were transferred from elsewhere for treatment. Our primary outcome measure was inpatient mortality. Our secondary outcome measure was hospital length of stay (LOS). Results We identified 491,011 records eligible for analysis. Of the patients, 30.6 % (150,101) had AGPNC. There were 1.34 deaths per 100 admissions in patients with AGPNC. The average LOS was 5.88 (± 6.38) days with a median stay of 4 days (range, 3–7). When adjusted for age, Elixhauser Comorbidity Index, and severe pancreatitis, patients with ERCP during admission were 43 % less likely to die. ERCP performed between Days 3 and 9 of hospitalization resulted in a significant mortality benefit. Among those who had ERCP, a shorter wait time for ERCP was associated with a shorter LOS after adjustment for demographics and severity of illness. Conclusion ERCP performed during inpatient admission for AGPNC was associated with decreased mortality. These data support early ERCP in patients with acute gallstone pancreatitis without cholangitis.


2021 ◽  
Vol 16 ◽  
Author(s):  
Debdipta Bose ◽  
Nithya Gogtay ◽  
Tejusv Goel ◽  
Mahanjit Konwar

Background: The black-box warning (BBW) is the most serious warning that US-FDA can ask for on a drug’s labelling. BBWs represent key safety concerns uncovered either during dossier review or post-approval. We have conducted the present study with the primary objective of assessing BBWs issued by the US-FDA. Methods: BBW’s were identified on US-FDA’s website from 1st January 2015 to 31st December 2019. Prescribing information was used to identify and characterize BBWs into new and minor/major update on a previous BBW. The therapeutic class of the drug, nature [Biological/New Molecular entity (NME)], formulation type, expected duration of use along with the year of first approval of the molecule with BBWs were evaluated. Results: A total of n = 167 BBWs were issued by FDA of which 53 (31.7%) had major updates, 57(34.1%) had minor updates and 57(34.1%) were new BBWs. A total of 137(82%) of BBWs were with NME’s whereas 30(18%) were with biologics. Drugs for neurology 40(25.5%)had the highest number of BBWs followed by oncology 38(24.2%). Among type of BBWs, cardiovascular risk 31 (15%) were the highest. Conclusion: Practicing physicians need to understand that benefit-risk of a drug is dynamic and keep abreast of new data related to it.


2017 ◽  
Vol 25 (3) ◽  
pp. 535-543 ◽  
Author(s):  
Herman J Johannesmeyer ◽  
Charles F Seifert

Objective The primary objective of this study was to identify factors that have predictive value in determining total hospital length of stay in patients with febrile neutropenia, particularly time to first antibiotic dose. Methods This study was a retrospective chart review analyzing patients admitted to a 443 bed tertiary county teaching hospital from 1 November 2010 through 1 November 2015. Patients were eligible for enrollment into the study if they met Infectious Diseases Society of America accepted criteria for febrile neutropenia. Results Ninety-three patients were included for analysis. Time to first antibiotic dose, first empirically appropriate antibiotic dose, and time to first isolate-appropriate antibiotic did not show a significant correlation to total hospital length of stay (p = 0.71, p = 0.342, and p = 0.77, respectively). Subject’s Multinational Association for Supportive Care in Cancer and Simplified Acute Physiology II scores were significantly correlated with hospital lengths of stay (p = 0.0052, rs = −0.243 and p = 0.0001, rs = 0.344, respectively). Higher median (interquartile ranges) Simplified Acute Physiology II scores were also associated with hospital mortality [dead = 46 (34.8–51.7) vs. alive = 34 (28–43.3), p = 0.0173]. Conclusions Measures of patient acuity, such as the Multinational Association for Supportive Care in Cancer and Simplified Acute Physiology II scores, did show a correlation to clinical outcomes in patients with febrile neutropenia. Timing of initial antibiotics between 2.32 and 6.27 hours after presentation in patients with febrile neutropenia did not correlate with clinical outcomes.


2015 ◽  
Vol 23 (3) ◽  
pp. 615-617 ◽  
Author(s):  
Ranjan Pathak ◽  
Smith Giri ◽  
Madan Raj Aryal ◽  
Paras Karmacharya ◽  
Vijaya Raj Bhatt ◽  
...  

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 208.2-208
Author(s):  
K. Mathias ◽  
A. Mantha ◽  
L. Mathias ◽  
D. Arkfeld

Background:Fibromyalgia is a chronic pain syndrome that is associated with protean symptoms including musculoskeletal pain, psychiatric symptoms, cognitive dysfunction, memory difficulty, and sleep disturbance. Fibromyalgia can be a primary diagnosis, or it can be associated with other conditions. Fibromyalgia is often seen in conjunction with autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis. In 1990, the American College of Rheumatology released classification criteria for fibromyalgia that included symptoms of diffuse pain and physical exam findings of at least 11 of 18 defined tender points. In 2010, the ACR updated these criteria and eliminated the requirement of tender points. In 2011, these criteria were further modified to that they could be self-administered. A previous study used the national inpatient sample to examine hospitalization data for patients with fibromyalgia from 1999-2007. 1 No studies, however, have examined this data since the new ACR criteria were established in 2010.Objectives:We aim to characterize the epidemiology of hospitalized patients with diagnosis of fibromyalgia.Methods:Hospitalized patients with a diagnosis of fibromyalgia were identified in the 2016-2018 National Inpatient Sample (NIS) using the International Classification of Diseases 10 system (ICD-10). The NIS is an all-payer inpatient database that estimates over 37 million annual U.S. hospitalizations and is maintained by the Healthcare Cost and Utilization Project. The primary outcomes were prevalence of fibromyalgia and comorbid rheumatologic conditions among hospitalized patients. Secondary outcomes included cause of admission, mortality, length of stay, and cost of care.Results:Of 1,351,234 patients with fibromyalgia identified, 437,145 were admitted in 2016 increasing to 461,820 in 2018. On average 59.1 years old, more likely female (1,262,735, 93.5%) and white (1,060,845, 81.3%). Patients were most likely to have Medicare (775,420, 57.5%) and were in the bottom quartile of income (402,945, 30.3%). The most common rheumatologic comorbidities were rheumatoid arthritis (142,195, 10.5%), lupus (69,980, 5.2%), and inflammatory bowel disease (38,165, 2.2%). Notably fibromyalgia was commonly associated with depression (500,420, 37.0%), obesity (379,324, 28.1%), hypothyroidism (334,585 24.7%), and congestive heart failure (213,790, 15.8%).The mortality rate was 13,605 (1.0%) patients, the average length of stay was (4.53 days), and the average cost of hospitalization ($12,522). The most common causes of admission were inflammatory syndromes and joint disorders (13.4%) of which OA (4.2%) was most common complaint, digestive complaints (12.1%) of which IBD (4.4%) was most common.Conclusion:The yearly number of fibromyalgia hospital discharges were greater than previously described. This may be a result of a more sensitive classification criteria. Further investigation into the etiology of this increase in fibromyalgia hospitalization diagnosis is warranted.References:[1]Haviland MG, Banta JE, Przekop P. Fibromyalgia: prevalence, course, and co-morbidities in hospitalized patients in the United States, 1999-2007. Clin Exp Rheumatol. 2011 Nov-Dec;29(6 Suppl 69):S79-87. Epub 2012 Jan 3. PMID: 22243553.Disclosure of Interests:None declared.


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