Christian Coles

Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) diary in patients with influenza-like illness (ILI)

Background The inFLUenza Patient Reported Outcome (FLU-PRO) measure is a daily diary assessing signs/symptoms of influenza across six body systems: Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic, developed and tested in adults with influenza. Objectives This study tested the reliability, validity, and responsiveness of FLU-PRO scores in adults with influenza-like illness (ILI). Methods Data from the prospective, observational study used to develop and test the FLU-PRO in influenza virus positive patients were analyzed. Adults (≥18 years) presenting with influenza symptoms in outpatient settings in the US, UK, Mexico, and South America were enrolled, tested for influenza virus, and asked to complete the 37-item draft FLU-PRO daily for up to 14-days. Analyses were performed on data from patients testing negative. Reliability of the final, 32-item FLU-PRO was estimated using Cronbach’s alpha (α; Day 1) and intraclass correlation coefficients (ICC; 2-day reproducibility). Convergent and known-groups validity were assessed using patient global assessments of influenza severity (PGA). Patient report of return to usual health was used to assess responsiveness (Day 1–7). Results The analytical sample included 220 ILI patients (mean age = 39.3, 64.1% female, 88.6% white). Sixty-one (28%) were hospitalized at some point in their illness. Internal consistency reliability (α) of FLU-PRO Total score was 0.90 and ranged from 0.72–0.86 for domain scores. Reproducibility (Day 1–2) was 0.64 for Total, ranging from 0.46–0.78 for domain scores. Day 1 FLU-PRO scores correlated (≥0.30) with the PGA (except Gastrointestinal) and were significantly different across PGA severity groups (Total: F = 81.7, p<0.001; subscales: F = 6.9–62.2; p<0.01). Mean score improvements Day 1–7 were significantly greater in patients reporting return to usual health compared with those who did not (p<0.05, Total and subscales, except Gastrointestinal and Eyes). Conclusions Results suggest FLU-PRO scores are reliable, valid, and responsive in adults with influenza-like illness.

Rapid changes in serum cytokines and chemokines in response to inactivated influenza vaccination

The timing of host cytokine responses to influenza vaccination is poorly understood.

Etiology and clinical characteristics of influenza-like illness in healthy adults by hospitalization status

Abstract Background Viral respiratory infections are a common cause of hospitalization for younger, otherwise-healthy populations. In this study, we describe the epidemiology of influenza-like illness in non-elderly adults within the U.S. Military Health System (MHS) by pathogen and hospitalization status. Methods The Acute Respiratory Infection Consortium (ARIC) is a prospective cohort of patients with influenza-like illness within the MHS. Participants between 18 and 65 years of age were identified in outpatient settings between 2012 and 2017, and were excluded if pregnant, if reporting chronic cardiac, respiratory, renal, or neurologic disease, or if on long-term aspirin therapy. Demographics, nasopharyngeal swabs and symptom data were collected; swabs were tested for viral pathogens using a target-enriched multiplex PCR panel (TEM-PCRTM, Diatherix LLC). Data were analyzed to compare clinical features and risks for hospitalization. Results 397 participants met inclusion criteria. 34 participants required hospitalization; 363 were outpatients. Median length of hospitalization was 2 days. A virus was identified in 58.4% of outpatients (OP) and 55.9% of inpatients (IP); coronaviruses (63/363), enteroviruses (50/363), and influenza A (73/363) predominated in OP, whereas influenza A predominated among IP (35.3%, 12/34). There were no significant differences between OP and IP in terms of age, gender, ethnicity, or tobacco use. IP were more likely to be obese (BMI ≥30, 43.3% vs. 20.5%, P = 0.004) and less likely to have received influenza vaccination (45.5% vs. 16.9%, P > 0.001). IP with influenza did not report more severe symptoms (chills, cough, sore throat, diarrhea, myalgia, or headache) on enrollment but were more likely to have fever (temperature ≥38.0⁰ C) than OP (92.9 vs. 57.1%, P = 0.014). Conclusion Influenza A is the most frequently identified cause of hospitalization among healthy, non-elderly adults with viral respiratory infection. Although age and tobacco use may be risks for viral acquisition, they do not appear to increase the risk of hospitalization in infected patients. Non-obese BMI and influenza vaccination appear protective against hospitalization, even in a relatively healthy cohort. Disclosures L. Malone, Diatherix Laboratories: Employee, Salary; E. Grigorenko, Diatherix Laboratories: Employee, Salary; D. Stalons, Diatherix Laboratories: Employee, Salary

Study to Address Threats of Acute Respiratory Infections among Congregate Military Populations (ATARI)

Abstract Background More than 90% of active duty personnel receive influenza vaccinations yearly. Despite high coverage, influenza-like illnesses (ILI) remain a frequent cause of missed duty and hospitalizations, particularly in U.S. military recruits. More research is needed on the epidemiology and etiology of ILI to reduce the burden of respiratory infections in congregated military settings. Methods We conducted a prospective cohort study to assess ILI patterns among US Army recruits in a 9-week basic combat training course at Ft. Benning, GA. Demographic data, vaccination history, and information on recent illness were collected at enrollment in January 2017. Participants were divided into two platoons with staggered biweekly visit schedules. Visits occurred from reception through training, with nasal swabs and symptom surveys (all visits) and blood draws (weeks 8 and 9). Nasal specimens were used to detect clinical and colonizing pathogens using the Diatherix TEM-PCR Respiratory Panel. Results A total of 90 recruits were enrolled in the study. Twelve recruits were lost due to training attrition in the first week of the study. The participants were male and the mean age was 23 yo (SD 4.9). There were 10 (13%) cases of ILI reported among the 78 remaining participants, 6 in week 1, 3 in week 2 and 1 in week 9. The most frequently detected pathogens in the 10 symptomatic cases were coronavirus (5, 50%), rhinovirus (4, 40%), other enterovirus (3, 30%), and influenza A (2, 20%). Pathogen co-detections were common, 8 out 10 cases were associated with 2 pathogens, representing 7 unique combinations. While rhinovirus and coronavirus were most common among asymptomatic trainees, 10% had detectable influenza A. Detection of multiple pathogens was common in the first two weeks of training (50% among those who had viral detection). The study is still in progress. Conclusion Symptomatic ILI was associated with coronavirus, rhinovirus, and enterovirus, in addition to influenza in the early weeks of training. Coronavirus and rhinovirus also circulated widely among healthy recruits, along with influenza. The findings will inform ILI control strategies for congregated military trainees. Disclosures E. Grigorenko, Diatherix Laboratories: Employee, Salary.L. Malone, Diatherix Laboratories: Employee, Salary.

Burden of Influenza-like Illness among military personnel receiving advanced training at Ft. Sam Houston, TX

Abstract Background Influenza-like illness (ILI) places a significant burden on operational readiness in the U.S. military, particularly in trainees who live and work in congregated settings. ILI incidence rates for the trainees are based on passive surveillance of those presenting to medical clinics. Such clinic-based surveillance may under-estimate the true ILI burden because trainees with ILI may not seek health care due to mild symptoms or fear of missing training. We aimed to estimate the hidden ILI burden among trainees and behaviors related to healthcare seeking for ILI. Methods A 1-page voluntary, anonymous ILI survey was administered during the end of program sessions for military medical trainees at Fort Sam Houston (JBSA-FSH), TX. The survey was started in January 2017 and is ongoing. Results Between January and April 2017, 724 surveys were returned: respondents were aged 17–42 years (median 20 yo), 299 (41%) were female, and 442 (62%) white. The trainees maintained a healthy and active life style: 94% exercised at least 3 times a week; 79% never smoked and only 3% were obese. Overall, 68% trainees reported ILI symptoms during training: the proportion decreased from 75% in January to 46% in April (P-for-trend <0.01). History of travel and self-reported contact to people with ILI were associated with reporting having ILI. Of those reporting ILI, only 36% sought health care, and the proportion did not change over the four month period. Females were more likely to seek health care if they developed ILI: 43% of females vs. 31% of males (P = 0.02). While the majority of trainees washed their hands or used hand sanitizer at least 4 times a day, only 60% of trainees washed their hands after covering their mouth/nose for a sneeze, which may facilitate ILI circulation in the population. Conclusion Among young and healthy medical trainees at JBSA-FSH, ILI was reported frequently during winter and decreased in spring. Trainees often did not seek health care for mild symptoms. The high prevalence of self-reported ILI among trainees despite their healthy life styles and good daily hand hygiene warrants further study. A better understanding of the impact of self-reported ILI on performance and of factors associated with health-care seeking are needed. Disclosures All authors: No reported disclosures.

Comparative Evaluation of Diatherix Target Enriched Multiplex Polymerase Chain Reaction and BioFire FilmArray in the Detection of Viral and Bacterial Respiratory Pathogens

238. Comparative Evaluation of Diatherix Target Enriched Multiplex Polymerase Chain Reaction and BioFire FilmArray in the Detection of Viral and Bacterial Respiratory Pathogens Wei-Ju Chen, PhD; John Arnold, MD; Mary Fairchok, MD; Erin Hansen, BS; Leslie Malone, MS, MB(ASCP)CM; Elena Grigorenko, PhD; Donald Stalons, PhD, D (ABMM), MPH; Jacqueline Owens Milzman, MS; Michelande Ridore, MS; Christian Coles, PhD; Timothy Burgess, MD; Eugene Millar, PhD; Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland; Naval Medical Center San Diego, San Diego, California; Madigan Army Medical Center, Tacoma, Washington; Naval Health Research Center, San Diego, California; Diatherix Laboratories, LLC, Huntsville, Alabama; Children’s National Medical Center, Washington, District of Columbia