Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-9 (of 9 Records) |
Query Trace: Brown NE[original query] |
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Clinical Course of SARS-CoV-2 Infection in Adults with ESKD Receiving Outpatient Hemodialysis
Bardossy AC , Korhonen L , Schatzman S , Gable P , Herzig C , Brown NE , Beshearse E , Varela K , Sabour S , Lyons AK , Overton R , Hudson M , Hernandez-Romieu AC , Alvarez J , Roman K , Weng M , Soda E , Patel PR , Grate C , Dalrymple LS , Wingard RL , Thornburg NJ , Halpin ASL , Folster JM , Tobin-D'Angelo M , Lea J , Apata I , McDonald LC , Brown AC , Kutty PK , Novosad S . Kidney360 12/28/2021 2 (12) 1917-1927 BACKGROUND: Patients with ESKD on maintenance dialysis receive dialysis in common spaces with other patients and have a higher risk of severe SARS-CoV-2 infections. They may have persistently or intermittently positive SARS-CoV-2 RT-PCR tests after infection. We describe the clinical course of SARS-CoV-2 infection and the serologic response in a convenience sample of patients with ESKD to understand the duration of infectivity. METHODS: From August to November 2020, we enrolled patients on maintenance dialysis with SARS-CoV-2 infections from outpatient dialysis facilities in Atlanta, Georgia. We followed participants for approximately 42 days. We assessed COVID-19 symptoms and collected specimens. Oropharyngeal (OP), anterior nasal (AN), and saliva (SA) specimens were tested for the presence of SARS-CoV-2 RNA, using RT-PCR, and sent for viral culture. Serology, including neutralizing antibodies, was measured in blood specimens. RESULTS: Fifteen participants, with a median age of 58 (range, 37‒77) years, were enrolled. Median duration of RT-PCR positivity from diagnosis was 18 days (interquartile range [IQR], 8‒24 days). Ten participants had at least one, for a total of 41, positive RT-PCR specimens ≥10 days after symptoms onset. Of these 41 specimens, 21 underwent viral culture; one (5%) was positive 14 days after symptom onset. Thirteen participants developed SARS-CoV-2-specific antibodies, 11 of which included neutralizing antibodies. RT-PCRs remained positive after seroconversion in eight participants and after detection of neutralizing antibodies in four participants; however, all of these samples were culture negative. CONCLUSIONS: Patients with ESKD on maintenance dialysis remained persistently and intermittently SARS-CoV-2-RT-PCR positive. However, of the 15 participants, only one had infectious virus, on day 14 after symptom onset. Most participants mounted an antibody response, including neutralizing antibodies. Participants continued having RT-PCR-positive results in the presence of SARS-CoV-2-specific antibodies, but without replication-competent virus detected. |
A standardized approach for collection of objective data to support outcome determination for late-phase TB trials
Kurbatova EV , Phillips PP , Dorman SE , Sizemore EE , Bryant KE , Purfield AE , Ricaldi J , Brown NE , Johnson JL , Wallis CL , Akol JP , Ocheretina O , Van Hung N , Mayanja-Kizza H , Lourens M , Dawson R , Nhung NV , Pierre S , Musodza Y , Shenje J , Badal-Faesen S , Vilbrun SC , Waja Z , Peddareddy L , Scott NA , Yuan Y , Vernon A , Goldberg SV , Swindells S , Chaisson RE , Nahid P . Am J Respir Crit Care Med 2023 207 (10) 1376-1382 INTRODUCTION: We developed a standardized method, "Possible poor treatment response" (PPTR), to help ascertain efficacy endpoints in Study S31/A5349 (NCT02410772), an open-label trial comparing two 4-month rifapentine-based regimens with a standard 6-month regimen for the treatment of pulmonary TB. We describe the use of the PPTR process and evaluate whether the goals of minimizing bias in efficacy endpoint assessment and attainment of relevant data to determine outcome for all participants were achieved. METHODS/DESIGN: A PPTR event was defined as the occurrence of one or more pre-specified triggers. Each PPTR required initiation of a standardized evaluation process that included obtaining multiple sputum samples for microbiology. RESULTS: Among 2,343 participants with culture-confirmed drug-susceptible TB, 454 individuals (19.4%) had a total of 534 individual PPTR events, of which 76.6% were microbiological (positive smear or culture at or after 17 weeks). At least one PPTR event was experienced by 92.4% (133 of 144) of participants with TB-related unfavorable outcome, and between 13.8 and 14.7% of participants with favorable and not assessable outcomes. 75% of participants with TB-related unfavorable outcomes had microbiological confirmation of failure to achieve disease-free cure. DISCUSSION: Standardized methodologies, such as our PPTR approach, could facilitate unbiased efficacy outcome determinations, improve discrimination between outcomes that are related and unrelated to regimen efficacy, and enhance the ability to conduct pooled analyses of contemporary trials. Clinical trial registration available at www. CLINICALTRIALS: gov, ID: NCT02410772. |
Invasive meningococcal disease among people experiencing homelessness-United States, 2016-2019
Rudmann KC , Brown NE , Blain A , Burns M , Ramsey A , Las Nueces D , Martin T , Barnes M , Davizon ES , Retchless AC , Potts C , Wang X , Hariri S , McNamara LA . J Infect Dis 2022 226 S322-S326 BACKGROUND: Recently, several invasive meningococcal disease (IMD) outbreaks caused by Neisseria meningitidis have occurred among people experiencing homelessness (PEH). However, overall IMD risk among PEH is not well described. We compared incidence and characteristics of IMD among PEH and persons not known to be experiencing homelessness (non-PEH) in the United States. METHODS: We analyzed 2016-2019 IMD data from the National Notifiable Diseases Surveillance System (NNDSS) and enhanced meningococcal disease surveillance. Incidence was calculated using U.S. census data and Point-in-Time counts from the U.S. Department of Housing and Urban Development. RESULTS: Of cases from states participating in enhanced surveillance during 2016-2019 (n = 1409), 45 (3.2%) cases occurred among PEH. Annual incidence was higher among PEH (2.12 cases/100,000) than non-PEH (0.11 cases/100,000; relative risk: 19.8, 95% CI: 14.8-26.7). Excluding outbreak-associated cases (PEH n = 18, 40%; non-PEH n = 98, 7.2%), incidence among PEH remained elevated compared to incidence in non-PEH (relative risk: 12.8, 95% CI: 8.8-18.8). Serogroup C was identified in 68.2% of PEH cases compared to 26.4% in non-PEH (p < 0.0001). CONCLUSIONS: PEH are at increased risk for IMD. Further assessment is needed to determine the feasibility and potential impact of meningococcal vaccination for PEH in the United States. |
Descriptive Evaluation of Antibody Responses to SARS-CoV-2 Infection in Plasma and Gingival Crevicular Fluid in a Nursing Home Cohort-Arkansas, June-August 2020.
Brown NE , Lyons AK , Schuh AJ , Stumpf MM , Harcourt JL , Tamin A , Rasheed MAU , Mills L , Lester SN , Thornburg NJ , Nguyen K , Costantini V , Vinjé J , Huang JY , Gilbert SE , Gable P , Bollinger S , Sabour S , Beshearse E , Surie D , Biedron C , Gregory CJ , Clemmons NS , Whitaker B , Coughlin MM , Seely KA , Garner K , Gulley T , Haney T , Kothari A , Patil N , Halpin AL , McDonald LC , Kutty PK , Brown AC . Infect Control Hosp Epidemiol 2021 43 (11) 1-24 OBJECTIVE: Characterize and compare SARS-CoV-2-specific immune responses in plasma and gingival crevicular fluid (GCF) from nursing home residents during and after natural infection. DESIGN: Prospective cohort. SETTING: Nursing home. PARTICIPANTS: SARS-CoV-2-infected nursing home residents. METHODS: A convenience sample of 14 SARS-CoV-2-infected nursing home residents, enrolled 4-13 days after real-time reverse transcription polymerase chain reaction diagnosis, were followed for 42 days. Post diagnosis, plasma SARS-CoV-2-specific pan-Immunoglobulin (Ig), IgG, IgA, IgM, and neutralizing antibodies were measured at 5 timepoints and GCF SARS-CoV-2-specific IgG and IgA were measured at 4 timepoints. RESULTS: All participants demonstrated immune responses to SARS-CoV-2 infection. Among 12 phlebotomized participants, plasma was positive for pan-Ig and IgG in all 12, neutralizing antibodies in 11, IgM in 10, and IgA in 9. Among 14 participants with GCF specimens, GCF was positive for IgG in 13 and IgA in 12. Immunoglobulin responses in plasma and GCF had similar kinetics; median times to peak antibody response was similar across specimen types (4 weeks for IgG; 3 weeks for IgA). Participants with pan-Ig, IgG, and IgA detected in plasma and GCF IgG remained positive through this evaluation's end 46-55 days post-diagnosis. All participants were viral culture negative by the first detection of antibodies. CONCLUSIONS: Nursing home residents had detectable SARS-CoV-2 antibodies in plasma and GCF after infection. Kinetics of antibodies detected in GCF mirrored those from plasma. Non-invasive GCF may be useful for detecting and monitoring immunologic responses in populations unable or unwilling to be phlebotomized. |
Estimated US Infection- and Vaccine-Induced SARS-CoV-2 Seroprevalence Based on Blood Donations, July 2020-May 2021.
Jones JM , Stone M , Sulaeman H , Fink RV , Dave H , Levy ME , Di Germanio C , Green V , Notari E , Saa P , Biggerstaff BJ , Strauss D , Kessler D , Vassallo R , Reik R , Rossmann S , Destree M , Nguyen KA , Sayers M , Lough C , Bougie DW , Ritter M , Latoni G , Weales B , Sime S , Gorlin J , Brown NE , Gould CV , Berney K , Benoit TJ , Miller MJ , Freeman D , Kartik D , Fry AM , Azziz-Baumgartner E , Hall AJ , MacNeil A , Gundlapalli AV , Basavaraju SV , Gerber SI , Patton ME , Custer B , Williamson P , Simmons G , Thornburg NJ , Kleinman S , Stramer SL , Opsomer J , Busch MP . JAMA 2021 326 (14) 1400-1409 IMPORTANCE: People who have been infected with or vaccinated against SARS-CoV-2 have reduced risk of subsequent infection, but the proportion of people in the US with SARS-CoV-2 antibodies from infection or vaccination is uncertain. OBJECTIVE: To estimate trends in SARS-CoV-2 seroprevalence related to infection and vaccination in the US population. DESIGN, SETTING, AND PARTICIPANTS: In a repeated cross-sectional study conducted each month during July 2020 through May 2021, 17 blood collection organizations with blood donations from all 50 US states; Washington, DC; and Puerto Rico were organized into 66 study-specific regions, representing a catchment of 74% of the US population. For each study region, specimens from a median of approximately 2000 blood donors were selected and tested each month; a total of 1 594 363 specimens were initially selected and tested. The final date of blood donation collection was May 31, 2021. EXPOSURE: Calendar time. MAIN OUTCOMES AND MEASURES: Proportion of persons with detectable SARS-CoV-2 spike and nucleocapsid antibodies. Seroprevalence was weighted for demographic differences between the blood donor sample and general population. Infection-induced seroprevalence was defined as the prevalence of the population with both spike and nucleocapsid antibodies. Combined infection- and vaccination-induced seroprevalence was defined as the prevalence of the population with spike antibodies. The seroprevalence estimates were compared with cumulative COVID-19 case report incidence rates. RESULTS: Among 1 443 519 specimens included, 733 052 (50.8%) were from women, 174 842 (12.1%) were from persons aged 16 to 29 years, 292 258 (20.2%) were from persons aged 65 years and older, 36 654 (2.5%) were from non-Hispanic Black persons, and 88 773 (6.1%) were from Hispanic persons. The overall infection-induced SARS-CoV-2 seroprevalence estimate increased from 3.5% (95% CI, 3.2%-3.8%) in July 2020 to 20.2% (95% CI, 19.9%-20.6%) in May 2021; the combined infection- and vaccination-induced seroprevalence estimate in May 2021 was 83.3% (95% CI, 82.9%-83.7%). By May 2021, 2.1 SARS-CoV-2 infections (95% CI, 2.0-2.1) per reported COVID-19 case were estimated to have occurred. CONCLUSIONS AND RELEVANCE: Based on a sample of blood donations in the US from July 2020 through May 2021, vaccine- and infection-induced SARS-CoV-2 seroprevalence increased over time and varied by age, race and ethnicity, and geographic region. Despite weighting to adjust for demographic differences, these findings from a national sample of blood donors may not be representative of the entire US population. |
Pneumococcal Disease Outbreak at a State Prison, Alabama, USA, September 1-October 10, 2018(1)
Sanchez GV , Bourne CL , Davidson SL , Ellis M , Feldstein LR , Fay K , Brown NE , Geeter EF , Foster LL , Gilmore C , McIntyre MG , Taylor B , Velusamy S , Chochua S , Matanock AM . Emerg Infect Dis 2021 27 (7) 1949-1952 A pneumococcal disease outbreak caused by Streptococcus pneumoniae serotype 12F occurred in a state prison in Alabama, USA. Among 1,276 inmates, 40 cases were identified (3 confirmed, 2 probable, 35 suspected). Close living quarters, substance use, and underlying conditions likely contributed to disease risk. Prophylaxis for close contacts included azithromycin and 23-valent pneumococcal polysaccharide vaccine. |
Racial disparities in invasive Haemophilus influenzae disease - United States, 2008-2017
Brown NE , Blain AE , Burzlaff K , Harrison LH , Petit S , Schaffner W , Smelser C , Thomas A , Triden L , Watt JP , Pondo T , Whaley MJ , Hu F , Wang X , Oliver S , Soeters HM . Clin Infect Dis 2021 73 (9) 1617-1624 BACKGROUND: Since the introduction of Haemophilus influenzae serotype b (Hib) conjugate vaccines in the United States, invasive H. influenzae disease (Hi) epidemiology has changed and racial disparities have not been recently described. METHODS: Active population- and laboratory-based surveillance for Hi was conducted through Active Bacterial Core surveillance (ABCs) at 10 U.S. sites. Data from 2008-2017 was used to estimate projected nationwide annual incidence in cases/100,000. RESULTS: During 2008-2017, ABCs identified 7379 Hi cases. Of 6705 (90.9%) patients with reported race, 76.2% were White, 18.6% were Black, 2.8% were Asian/Pacific Islander (PI), and 2.4% were American Indian and Alaska Native (AI/AN). Nationwide annual incidence was 1.8 cases/100,000. By race, incidence was highest among AI/AN populations (3.1) and lowest among Asian/PI populations (0.8). Nontypeable Hi (NTHi) caused the largest incidence within all races (1.3), with no striking disparities identified. Among AI/AN children aged <5 years, incidence of Hi serotype a (Hia) was 16.7 times higher and Hib incidence was 22.4 times higher than among White children. Though Hia incidence was lower among White and Black populations compared to AI/AN, Hia incidence increased 13.6% annually among White children and 40.4% annually among Black children aged <5 years. CONCLUSIONS: While NTHi causes the largest Hi burden overall, AI/AN populations experience disproportionately high rates of Hia and Hib, with the greatest disparity among AI/AN children aged <5 years. Prevention tools are needed to reduce disparities affecting AI/AN children and address increasing Hia incidence in other communities. |
Central monitoring in a randomized, open-label, controlled phase 3 clinical trial for a treatment-shortening regimen for pulmonary tuberculosis
Bryant KE , Yuan Y , Engle M , Kurbatova EV , Allen-Blige C , Batra K , Brown NE , Chiu KW , Davis H , Elskamp M , Fagley M , Fedrick P , Hedges KNC , Narunsky K , Nassali J , Phan M , Phan H , Purfield AE , Ricaldi JN , Robergeau-Hunt K , Whitworth WC , Sizemore EE . Contemp Clin Trials 2021 104 106355 INTRODUCTION: With the growing use of online study management systems and rapid availability of data, timely data review and quality assessments are necessary to ensure proper clinical trial implementation. In this report we describe central monitoring used to ensure protocol compliance and accurate data reporting, implemented during a large phase 3 clinical trial. MATERIAL AND METHODS: The Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) study A5349 (S31) is an international, multi-site, randomized, open-label, controlled, non-inferiority phase 3 clinical trial comparing two 4-month regimens to a standard 6 month regimen for treatment of drug-susceptible tuberculosis (TB) among adolescents and adults with a sample size of 2500 participants. RESULTS: Central monitoring utilized primary study data in a five-tiered approach, including (1) real-time data checks & topic-specific intervention reports, (2) missing forms reports, (3) quality assurance metrics, (4) critical data reports and (5) protocol deviation identification, aimed to detect and resolve quality challenges. Over the course of the study, 240 data checks and reports were programed across the five tiers used. DISCUSSION: This use of primary study data to identify issues rapidly allowed the study sponsor to focus quality assurance and data cleaning activities on prioritized data, related to protocol compliance and accurate reporting of study results. Our approach enabled us to become more efficient and effective as we informed sites about deviations, resolved missing or inconsistent data, provided targeted guidance, and gained a deeper understanding of challenges experienced at clinical trial sites. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015. |
Antibody Responses after Classroom Exposure to Teacher with Coronavirus Disease, March 2020.
Brown NE , Bryant-Genevier J , Bandy U , Browning CA , Berns AL , Dott M , Gosciminski M , Lester SN , Link-Gelles R , Quilliam DN , Sejvar J , Thornburg NJ , Wolff BJ , Watson J . Emerg Infect Dis 2020 26 (9) 2263-5 After returning from Europe to the United States, on March 1, 2020, a symptomatic teacher received positive test results for severe acute respiratory syndrome coronavirus 2. Of the 21 students exposed to the teacher in the classroom, serologic results suggested past infection for 2. Classroom contact may result in virus transmission. |
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