bluuebunny/crossref_metadata_2025_split huggingface dataset:
2296. Hypoglycemia Risk with Antibiotics: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)
Authors: Kennedy Kaitlin E , Teng Chengwen , Patek Taylor M , Frei Christopher R 
Published: October 2019

Abstract

Background
In July of 2018, the FDA published a drug safety warning for the potential risk of developing hypoglycemia with fluoroquinolones. Some studies have evaluated the potential risk of developing hypoglycemia with linezolid and tigecycline. A few case reports have also been published that report hypoglycemia from cefditoren, doxycycline, and trimethoprim-sulfamethoxazole use. Since data comparing various antibiotics and the risk of developing hypoglycemia is limited, the objective of this study was to evaluate the association between hypoglycemia and antibiotics using the FDA Adverse Event Reporting Systems (FAERS).

Methods
FAERS reports from January 1, 2004 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of hypoglycemia. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and hypoglycemia were calculated. An association was considered to be statistically significant when the lower limit of the 95% CI was greater than 1.0.

Results
A total of 2,334,959 reports (including 18,466 hypoglycemia reports) were considered, after inclusion criteria were applied. Cefditoren had the greatest proportion of hypoglycemia reports, representing 10% of all cefditoren reports. Statistically significant hypoglycemia RORs (95% CI) for antibiotics were: cefditoren 14.03 (8.93–22.03), tigecycline 3.32 (1.95–5.65), clarithromycin 2.41 (1.89–3.08), ertapenem 2.07 (1.14–3.75), moxifloxacin 2.06 (1.59–2.65), levofloxacin 1.66 (1.37–2.01), linezolid 1.54 (1.07–2.20).

Conclusion
Cefditoren, tigecycline, clarithromycin, ertapenem, moxifloxacin, levofloxacin, and linezolid were all significantly associated with hypoglycemia. The ertapenem association had not been reported in prior literature. Levofloxacin and moxifloxacin were the only fluoroquinolones significantly associated with hypoglycemia, even though the FDA drug safety warning was issued for all fluoroquinolones. Doxycycline and trimethoprim-sulfamethoxazole were not significantly associated with hypoglycemia, even though case reports have reported hypoglycemia with doxycycline and trimethoprim-sulfamethoxazole.

Disclosures
All authors: No reported disclosures.
2298. Infections in Patients Receiving TVEC Therapy
Authors: Robilotti Elizabeth , Kamboj Mini 
Published: October 2019

Abstract

Background
Oncolytic viral immunotherapy is an emerging cancer treatment, but the infectious complications are not well described outside of clinical trials. Genetically engineered replication competent herpes simplex virus (HSV-1), commercially known as IMLGYIC® (AmGen) or talimogene laherparepvec (TVEC) was the first FDA approved agent in this class and is used for the local intralesional treatment (of unresectable melanoma. TVEC is derived from a wild-type(WT) strain of HSV-1 (JS—1), which is modified to attenuate off-target effects and promote selective proliferation within cancer cells. Despite these changes local and systemic infection with HSV have been reported from trials and is the subject of an FDA mandated post-marketing review. Here we review the infectious complications of the first cohort of patients treated at our institution post-FDA approval.

Methods
Demographic and clinical information for 52 adult patients treated for unresectable melanoma with TVEC following FDA approval in 2015 was extracted from the EMR for the period October 1, 2015–June 30, 2018. EMR and microbiologic data were reviewed for evidence of local site reaction and disseminated infection.

Results
No cases of disseminated HSV infection were identified during the study period. Of cutaneous reactions, none were documented as greater than severity grade 2, based on standard adverse event reporting criteria. 3 (50%) grade 1–2 cutaneous reactions were deemed probable or definitely related to TVEC and described as pruritis or rash. 12 (23%) patients had any microbiologically confirmed infection identified following TVEC therapy; 6 were bacterial (3 UTI, 1BSI, 2 wound). 8 episodes of viral infections occurred (5 respiratory and 3 GI). A single patient was noted to have localized HSV dermal lesions more than one year after the final TVEC.

Conclusion
No local or disseminated HSV infections were encountered in the study cohort. Bacterial skin and soft-tissue infection were uncommon. Most other infections were unrelated to TVEC therapy. Real-world review of the use of an HSV-derived oncolytic viral vector therapy mimics reported infectious complications from clinical trials.

Disclosures
All authors: No reported disclosures.
2308. Comparison of Clinical Characteristics Between Laboratory-Confirmed Positive and Negative Patients with Severe Fever with Thrombocytopenia Syndrome
Authors: Oh Suhyun , Rae You Jeong , Taek Heo Sang , Jo Sujin 
Published: October 2019

Abstract

Background
Severe fever with thrombocytopenia syndrome (SFTS) is a tick-borne emerging infectious disease caused by SFTS virus (SFTSV). Mortality of SFTS estimated to be 21.8% in South Korea, and this disease is difficult differential diagnosis. Here, we analyzed clinical characteristics between SFTS positive group (SPG) and negative group (SNG) in a primary clinical setting.

Methods
In this prospective observational study, data were collected on patients with SFTS test performed at the single teaching hospital, in South Korea, between April 2013 and December 2018. The association between each demographic, climatic, clinical, and laboratory variable was assessed. All SFTS was confirmed at the KCDC by detecting the M segment gene of SFTSV RNA using reverse transcription-polymerase chain reaction (RT–PCR), and were confirmed at our laboratory by S segment gene of SFTSV RNA using RT–PCR about patient’s family member and those with close contact.

Results
Of the 199 patients in the study periods, 61 (31%) were SPG and 138 (69%) were SNG. Mean age was 55.1 ± 20.3 years, and 103 (52%) patients were male. In SPG, the comorbidity score and history of tick bite were significantly higher compared with SNG. SPG and SNG were prevalent in summer and autumn, respectively (60.7% vs. 45.7%, P < 0.05). SPG was associated with mean outdoor temperature, humidity and rainfall compared with SNG (22.9°Cvs. 18.9 ℃; 78.8% vs. 70.6%; 12.6 mm vs. 8.5 mm, all P < 0.01). Dizziness, poor oral intake, nausea, and diarrhea were common in SPG. In laboratory findings, white blood cell counts, absolute neutrophil count, and C-reactive protein were significantly lower in SPG. Lymphocyte fraction, activated partial thromboplastin time, and creatinine phosphokinase were significantly higher in SPG. Case fatality of the SPG and SNG were 9.8% and 1.0%, respectively. In multivariate analysis, mean outdoor temperature, humidity, dizziness, and low CRP were predictive factors in SPG.

Conclusion
Early prediction of SFTS diagnosis is important because this emerging zoonotic disease was a high fatality in endemic areas. When a physician wants to do SFTS test, they would consider according to this predictive variable for differentiating SFTS in primary care settings.

Disclosures
All authors: No reported disclosures.
2319. Clinical Predictors of Influenza and Hospitalization of Children with Influenza in an Emergent Care Setting
Authors: Rao Suchitra , Lamb Molly , Moss Angela , Yanni Emad , Bekkat-Berkani Rafik , Schuind Anne , Innis Bruce , Asturias Edwin J 
Published: October 2019

Abstract

Background
Objective measures utilizing early vital sign data show promise in predicting more severe outcomes among adults with influenza, but data are sparse in children. The objectives of this study were to determine the value of vital signs in predicting influenza infection or hospitalization due to influenza infection among children evaluated in an emergency department (ED) or urgent care (UC) setting in Colorado.

Methods
We evaluated vital signs obtained from a prospective cohort study of children aged 6 months to 8 years of age with influenza like illness evaluated at an ED/UC site in Aurora, CO from 2016–2018, and who underwent influenza testing by PCR. We collected the first set of vital signs, peak heart rate and temperature, and converted heart rate (HR) and respiratory rate (RR) to z-scores by age. HR z scores were further adjusted for temperature. Bivariable analyses for each vital sign as a predictor of influenza-related hospitalization and influenza infection as main outcomes were conducted. Predictors with P < 0.2 were entered into a multivariable logistic regression model to determine odds ratios (OR) and 95% CI; model performance was assessed using the Brier score and discriminative ability with the C statistic.

Results
Among 1478 children, 411 were positive for influenza, of which 28 were hospitalized. In multivariable analyses, among children with influenza infection, lower initial oxygen saturation (OR 0.87, 95% CI 0.78–0.98, P = 0.026) and higher adjusted respiratory rate (OR 2.09, 95% CI 1.21–3.61, P = 0.0085) were significant predictors of hospitalization (Figure 1). Among children with ILI, higher peak temperature (OR 1.46, 95% CI 1.30–1.63, P < 0.0001), lower adjusted peak heart rate (OR 0.79, 95% CI 0.69–0.90, P = 0.0005), higher initial oxygen saturation (OR 1.07, 95% CI 1.03–1.12 P = 0.002) and lower adjusted respiratory rate (OR 0.74, 95% CI 0.64–0.87, P = 0.0002) were significant predictors for having PCR-confirmed influenza. However, this model had poor calibration and discriminatory ability.

Conclusion
Higher respiratory rate adjusted for age and lower initial oxygen saturation were significant predictors of hospitalization among young children with PCR-confirmed influenza, but were not reliable discriminators of having influenza infection.

Disclosures
All authors: No reported disclosures.
2329. Incidences and Characteristics of Influenza Among Pregnant Women in Middle-Income Countries: Preliminary Results of the Pregnancy and Influenza Multinational Epidemiologic (PRIME) Study
Authors: Dawood Fatimah S , Tinoco Yeny , Suntarratiwong Piyarat , Patel Archana , Hunt Danielle R , Kittikraisak Wanitchaya , Soto Giselle , Das Prabir Kumar , Wesley Meredith G , Hombroek Danielle , Florian Richard , Gonzales Oswaldo , Kurhe Kunal , Cabrera Santiago , Llajaruna Zumaeta Edwin , Prakash Amber A , Sinthuwattanawibool Chalinthorn , Mott Joshua , Brummer Tana , Malek Parker , Saha Siddhartha , Chang Howard , Lindstrom Stephen , Arriola Carmen S , Garg Shikha , Mundhada Shailendra G , Deshmukh Madhavi , Klungthong Chonticha , Thompson Mark G , Azziz-Baumgartner Eduardo 
Published: October 2019

Abstract

Background
The World Health Organization recommends influenza vaccination for pregnant women. However, few data exist on influenza incidence and clinical course among pregnant women in middle-income countries where influenza vaccine use during pregnancy is often limited. We conducted a prospective cohort study of pregnant women to estimate incidences of influenza in Lima, Peru; Bangkok, Thailand; and Nagpur, India.

Methods
Prior to and early in the 2017 and 2018 influenza seasons, we enrolled pregnant women aged > 18 years with expected delivery dates > 8 weeks after the start of the season. We contacted women twice weekly until end of pregnancy to identify illnesses with myalgia, cough, runny nose, sore throat, or difficulty breathing and collected nasal swabs from symptomatic women for influenza real-time reverse transcription polymerase chain reaction testing. Using 2017 cohort data, we calculated crude incidences per 10,000 pregnancy-months during influenza season by site and trimester and overall incidence weighted for population of women of childbearing age in each country.

Results
We enrolled 4774 women with a median age of 26 years (interquartile range [IQR] 23–31) and gestational age of 20 weeks (IQR 15–24); 15% received influenza vaccine. Local influenza seasons spanned 4.5–8 months. Overall, 143 participants (3%) had influenza (113 (79%) influenza A and 30 (21%) influenza B). Weighted influenza incidence was 88.7/10,000 pregnancy-months (95% CI 68.6–114.8), though incidences varied up to two-fold by site (Figure 1). Incidences did not differ by pregnancy trimester (Figure 2). Among the 143 influenza episodes, the median duration was 7 days (IQR 5–10), 30% involved fever or chills, 43% disrupted daily activities, 47% prompted medical attention, 4% were associated with hospitalization, and < 1% were treated with antiviral medications.

Conclusion
Overall, pregnant women had an average risk of influenza of 0.9% per month of pregnancy spent in the influenza season with almost half of illnesses disrupting daily activities and prompting medical attention. Influenza-associated hospitalization was infrequent. These findings provide valuable inputs to estimate illnesses averted by vaccine programs and evaluate their cost–benefit among pregnant women in middle-income countries.

Disclosures
All authors: No reported disclosures.
2331. Seroprevalence of Cytomegalovirus in Pregnant Women and Birth Prevalence of Congenital Cytomegalovirus Infection in Henan Province, China
Authors: Huang Yue , Li Tingdong , Song Qiaoqiao , Man Tengfei , Wang Han , Guo Xiaoyi , Yu Huan , Adam Cui Yadong , Wu Ting , Marks Morgan , Fu Tong-Ming , Ge Shengxiang , Xia Ningshao , Zhang Jun 
Published: October 2019

Abstract

Background
Congenital cytomegalovirus infection (cCMVi) is the leading viral cause of birth defects and developmental disabilities in newborns. The epidemiology of cCMVi in settings with high cytomegalovirus (CMV) seroprevalence, such as China, is not well studied. This study sought to describe maternal CMV seroprevalence and cCMVi prevalence at birth in Henan Province, China.

Methods
A multicenter prospective cohort study was conducted in three counties of Henan Province in China from June 2015 through May 2018. Pregnant women were enrolled early in pregnancy and followed up through delivery. Serum specimens were collected at enrollment for CMV immunoglobulin G serological testing. Saliva and urine specimens were collected in newborns within 72 hours after birth and tested with real-time polymerase chain reaction for CMV DNA. cCMVi was defined as CMV DNA positive in the infants’ urine or saliva specimens.

Results
A total of 6327 pregnant women underwent CMV serological testing and 6062 were CMV seropositive (95.8%). The maternal age was 26.8 ± 4.3 (mean ± SD) years. There were 49 (0.7%) newborns identified with cCMVi among 6705 newborns screened. Lower maternal education level (middle school or lower), younger maternal age (<25 years) and twin-pregnancy were associated with higher cCMVi prevalence (P = 0.04, 0.016, and 0.001, respectively).

Conclusion
Despite a high maternal CMV seroprevalence in this large cohort study from China, the birth prevalence of cCMVi is similar to other studies in settings of high and medium CMV seroprevalence. In settings of high maternal CMV seroprevalence, additional research is needed to ascertain the relative contribution of non-primary CMV infections during pregnancy to congenital transmission.

Disclosures
All authors: No reported disclosures.
2333. Influenza-Related Neurologic Complications in Hospitalized Children with Underlying Neurologic Disorders
Authors: Frankl Sarah , Coffin Susan E , Swami Sanjeev , McGuire Jennifer 
Published: October 2019

Abstract

Background
Children with underlying neurological and neuromuscular conditions are considered “high risk” for developing severe infection due to influenza. Prior reports highlighted this population’s increased risk for respiratory failure. Little is known about neurological complications experienced by children with pre-existing neurologic disorders (PNDs) when infected with influenza.

Methods
Retrospective cohort study of children 0.5–18.0 years old hospitalized at a tertiary care pediatric hospital between August 2010 and June 2017 with laboratory-confirmed influenza. Eligible children were identified by electronic medical record query for influenza assay CPT codes with positive results during an admission; cases were confirmed by chart review. Demographics and clinical data were abstracted.

Results
A total of 1217 immune competent children (median age 5.5 [IQR 2.2–9.8] years) were hospitalized with laboratory-confirmed influenza during the study period. About 28% (341/1217) had at least one PND, including epilepsy (n = 105), developmental delay or intellectual disability (n = 234), neurogenetic or metabolic disorders (n = 77), neuromuscular disorders (n = 22) and others (n = 253). Compared with previously healthy peers, these children were more often admitted to the intensive care unit (31% vs. 16%, P < 0.001), had a longer length of stay (3 vs. 2 days, P < 0.001), and had a higher incidence of neurologic complications (23% vs. 6%, P < 0.001). Seizures (18% vs. 4%, P < 0.001) and encephalopathy (8% vs. 2%, P < 0.001) in particular were more common in children with PNDs, but other neurologic complications occurred in comparable proportions (3% vs. 1%, P = 0.088). Only 49% of the overall cohort had documented annual influenza vaccine; coverage was slightly better for children with PNDs than those without (55% vs. 48%, P = 0.017). The odds of having a neurologic complication in children with documented vaccination was nearly half that of other children when adjusted for age, influenza strain, and any PND (adjusted OR 0.64, 95% CI 0.44–0.94, P = 0.021).

Conclusion
The excess risk of neurological complications in children with PNDs highlights the importance of vaccinating this population. Additional consideration should be given to post-exposure prophylaxis for children with PNDs who have not received vaccine.

Disclosures
All authors: No reported disclosures.
2336. Adherence to Follow-up and CMV Testing in Infants Who Failed Newborn Hearing Screens: Evaluation of New Protocol to Ensure Follow-up and Testing
Authors: Penton Manuel , Herzog Aaron , Pan Jun , Manopla Charles , Otto Caitlin , Kohlhoff Stephan 
Published: October 2019

Abstract

Background
CMV is the most common non-hereditary cause of sensorineural hearing loss (SNHL) in children in the United States. SNHL may be the only presenting symptom in otherwise asymptomatic infants. Several states are making CMV testing mandatory for newborn infants who have a hearing deficit. Testing should be performed before 21 days of life to diagnose congenital CMV infection and provide effective therapy. However, the results of a retrospective 1 year audit of all newborn patients in the nursery of University Hospital of Brooklyn (UHB) who failed their hearing screen found that none were tested for CMV and approximately half failed to follow-up with audiology. Therefor we developed a new protocol to ensure testing and follow-up.

Methods
Under the new protocol, newborns who fail an initial and repeat hearing screen are tested for CMV in urine by culture and the audiology appointment is scheduled before discharge. Patients are tracked by a pediatric infectious disease fellow to ensure adherence to protocol.

Results
The pre-intervention audit conducted from November 1, 2017 to October 31, 2018 found 37/923 (4%) infants failed their hearing screening tests. Although 34/37 (92%) of these children had audiology appointments made before discharge, only 19 (56%) actually attended. Two (11%) children failed an otoacoustic emissions hearing test. One infant also went on to fail an auditory brainstem response test; both were lost to follow-up. None of these infants was tested for CMV. The new protocol was initiated November 1, 2018, 11/372 (3%) infants failed initial and repeat hearing screening tests. All 11 (100%) of these children had audiology appointments made before discharge, of which 9 (82%) attended. 2 (18%) of these children failed the otoacoustic emissions hearing test at that visit, 1 infant was lost to follow-up; 9 infants who failed hearing test were tested for CMV; 1 (9%) was positive.

Conclusion
Although it has only been in place for 5 months, the new protocol has increased adherence to audiology appointments. CMV testing has increased from 0% to 82% and 1 patient has tested positive for congenital CMV infection. The ongoing success of this protocol could facilitate timely and appropriate treatment of CMV with valgancyclovir.

Disclosures
All authors: No reported disclosures.
2343. How Smart Is the Chart? Accuracy of the Medical Record in Documenting Diarrhea in Patients Tested for Clostridium difficile Infection
Authors: Pora Gavriella , Karen Ng Wong Y , Jury Lucy , Donskey Curtis 
Published: October 2019

Abstract

Background
Inappropriate testing for Clostridium difficile infection (CDI) may result in diagnosis of CDI in asymptomatic carriers with diarrhea due to other causes such as laxatives. Current guidelines suggest that periodic chart review may be useful to assess the appropriateness of CDI testing, but it is not known how accurate the medical record is in documenting diarrhea.

Methods
We conducted a prospective cohort study of 80 patients tested for CDI to determine the accuracy of diarrhea documentation in the medical record in comparison to patient interviews and to assess the appropriateness of testing.

Results
Thirty-five of 80 (44%) CDI tests were deemed inappropriate because patients either did not have clinically significant diarrhea (i.e., 3 or more unformed stools per day) or had an alternative explanation for diarrhea. Seventy-four of 80 (93%) patients stated they had diarrhea, but only 53 (66%) had clinically significant diarrhea based on symptom review. Physician and/or nursing notes documented diarrhea in 67 of 80 (84%) patients, but the number of bowel movements and the consistency of stool were documented for only 36 (45%) and 41 (51%) patients.

Conclusion
In our facility, inappropriate CDI testing was common and the accuracy of the medical record in documenting diarrhea was suboptimal. Education of patients and providers may be beneficial in improving the accuracy of diarrhea documentation and the appropriateness of testing.

Disclosures
All authors: No reported disclosures.