Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 39
Filtrar
1.
PLoS One ; 18(6): e0286297, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37352211

RESUMEN

IMPORTANCE: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. METHODS: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. DISCUSSION: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options. REGISTRATION: NCT05172024.


Asunto(s)
COVID-19 , Humanos , COVID-19/epidemiología , Estudios Observacionales como Asunto , Síndrome Post Agudo de COVID-19 , Estudios Prospectivos , Estudios Retrospectivos , SARS-CoV-2 , Adolescente , Adulto , Estudios Multicéntricos como Asunto
3.
PLOS Glob Public Health ; 2(3): e0000198, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36962289

RESUMEN

Antiretroviral therapy (ART) is a lifesaving intervention for people living with HIV infection, reducing morbidity and mortality; it is likewise essential to reducing transmission. The "Treat all" strategy recommended by the World Health Organization has dramatically increased ART eligibility and improved access. However, retaining patients on ART has been a major challenge for many national programs in low- and middle-income settings, despite actionable local policies and ambitious targets. To estimate retention of patients along the HIV care cascade in Liberia, and identify factors associated with loss-to-follow-up (LTFU), death, and suboptimal treatment adherence, we conducted a nationwide retrospective cohort study utilizing facility and patient-level records. Patients aged ≥15 years, from 28 facilities who were first registered in HIV care from January 2016 -December 2017 were included. We used Cox proportional hazard models to explore associations between demographic and clinical factors and the outcomes of LTFU and death, and a multinomial logistic regression model to investigate factors associated with suboptimal treatment adherence. Among the 4185 records assessed, 27.4% (n = 1145) were males and the median age of the cohort was 37 (IQR: 30-45) years. At 24 months of follow-up, 41.8% (n = 1751) of patients were LTFU, 6.6% (n = 278) died, 0.5% (n = 21) stopped treatment, 3% (n = 127) transferred to another facility and 47.9% (n = 2008) were retained in care and treatment. The incidence of LTFU was 46.0 (95% CI: 40.8-51.6) per 100 person-years. Relative to patients at WHO clinical stage I at first treatment visit, patients at WHO clinical stage III [adjusted hazard ratio (aHR) 1.59, 95%CI: 1.21-2.09; p <0.001] or IV (aHR 2.41, 95%CI: 1.51-3.84; p <0.001) had increased risk of LTFU; whereas at registration, age category 35-44 (aHR 0.65, 95%CI: 0.44-0.98, p = 0.038) and 45 years and older (aHR 0.60, 95%CI: 0.39-0.93, p = 0.021) had a decreased risk. For death, patients assessed with WHO clinical stage II (aHR 2.35, 95%CI: 1.53-3.61, p<0.001), III (aHR 2.55, 95%CI: 1.75-3.71, p<0.001), and IV (aHR 4.21, 95%CI: 2.57-6.89, p<0.001) had an increased risk, while non-pregnant females (aHR 0.68, 95%CI: 0.51-0.92, p = 0.011) and pregnant females (aHR 0.42, 95%CI: 0.20-0.90, p = 0.026) had a decreased risk when compared to males. Suboptimal adherence was strongly associated with the experience of drug side effects-average adherence [adjusted odds ratio (aOR) 1.45, 95% CI: 1.06-1.99, p = 0.02) and poor adherence (aOR 1.75, 95%CI: 1.11-2.76, p = 0.016), and attending rural facility decreased the odds of average adherence (aOR 0.01, 95%CI: 0.01-0.03, p<0.001) and poor adherence (aOR 0.001, 95%CI: 0.0004-0.003, p<0.001). Loss-to-follow-up and poor adherence remain major challenges to achieving viral suppression targets in Liberia. Over two-fifths of patients engaged with the national HIV program are being lost to follow-up within 2 years of beginning care and treatment. WHO clinical stage III and IV were associated with LTFU while WHO clinical stage II, III and IV were associated with death. Suboptimal adherence was further associated with experience of drug side effects. Active support and close monitoring of patients who have signs of clinical progression and/or drug side effects could improve patient outcomes.

4.
Disaster Med Public Health Prep ; 17: e72, 2021 11 25.
Artículo en Inglés | MEDLINE | ID: mdl-34819204

RESUMEN

Infectious disease outbreaks on the scale of the current coronavirus disease 2019 (COVID-19) pandemic are a new phenomenon in many parts of the world. Many isolation unit designs with corresponding workflow dynamics and personal protective equipment postures have been proposed for each emerging disease at the health facility level, depending on the mode of transmission. However, personnel and resource management at the isolation units for a resilient response will vary by human resource capacity, reporting requirements, and practice setting. This study describes an approach to isolation unit management at a rural Uganda Hospital and shares lessons from the Uganda experience for isolation unit managers in low- and middle-income settings.


Asunto(s)
COVID-19 , Enfermedades Transmisibles , Humanos , COVID-19/epidemiología , Uganda/epidemiología , Brotes de Enfermedades , Instituciones de Salud , Equipo de Protección Personal
5.
Ann Intern Med ; 174(12): 1727-1732, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34724402

RESUMEN

Biorepositories provide a critical resource for gaining knowledge of emerging infectious diseases and offer a mechanism to rapidly respond to outbreaks; the emergence of the novel coronavirus, SARS-CoV-2, has proved their importance. During the COVID-19 pandemic, the absence of centralized, national biorepository efforts meant that the onus fell on individual institutions to establish sample repositories. As a safety-net hospital, Boston Medical Center (BMC) recognized the importance of creating a COVID-19 biorepository to both support critical science at BMC and ensure representation in research for its urban patient population, most of whom are from underserved communities. This article offers a realistic overview of the authors' experience in establishing this biorepository at the onset of the COVID-19 pandemic during the height of the first surge of cases in Boston, Massachusetts, with the hope that the challenges and solutions described are useful to other institutions. Going forward, funders, policymakers, and infectious disease and public health communities must support biorepository implementation as an essential element of future pandemic preparedness.


Asunto(s)
Centros Médicos Académicos/organización & administración , COVID-19/prevención & control , Control de Infecciones/métodos , Pandemias , Manejo de Especímenes , Boston , Humanos , SARS-CoV-2 , Proveedores de Redes de Seguridad , Población Urbana
6.
Int J Infect Dis ; 112: 13-20, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34433096

RESUMEN

OBJECTIVE: Interrupted time-series analyses, using 5 years of routinely collected health information system data, were conducted to estimate the magnitude of impact of the 2014-2015 Ebola virus disease (EVD) epidemic and determine trends in tuberculosis (TB) care services in Liberia. METHODS: A segmented linear regression model was used to generate estimates and predictions for trends for three TB service indicators before, during, and after EVD, from January 2013 to December 2017. RESULTS: It was found that the number of presumptive TB cases declined significantly at the start of the EVD outbreak, with an estimated loss of 3222 cases (95% confidence interval (CI) -5691 to -752; P = 0.014). There was also an estimated loss of 709 cases per quarter post-EVD (95% CI -1346 to -71; P = 0.032). However, over the post-EVD period, quarterly increases were observed in the proportion of smear-positive to presumptive cases (1.45%, 95% CI 0.38% to 2.5%; P = 0.011) and the proportion of treatment success to TB cases evaluated (3.3%, 95% CI 0.82% to 5.79%; P = 0.013). CONCLUSIONS: These findings suggest that the EVD outbreak (2014-2015) negatively affected TB care services. Rigorous quantitative analyses can be used to assess the magnitude of interruption and advocate for preparedness in settings with limited healthcare capacity.


Asunto(s)
Epidemias , Fiebre Hemorrágica Ebola , Tuberculosis , Brotes de Enfermedades , Fiebre Hemorrágica Ebola/diagnóstico , Fiebre Hemorrágica Ebola/epidemiología , Humanos , Liberia/epidemiología , Tuberculosis/diagnóstico , Tuberculosis/epidemiología
7.
Cell Host Microbe ; 29(7): 1036-1039, 2021 07 14.
Artículo en Inglés | MEDLINE | ID: mdl-34265241

RESUMEN

Global vaccine inequity is prolonging the COVID-19 pandemic. Here, we outline the scope and impact of inequitable vaccine distribution and identify challenges in vaccine development, manufacturing, and distribution as well as potential solutions to address this crisis.


Asunto(s)
Vacunas contra la COVID-19/provisión & distribución , COVID-19/prevención & control , Pandemias/prevención & control , Investigación Biomédica , Vacunas contra la COVID-19/normas , China , Humanos , Instalaciones Industriales y de Fabricación , SARS-CoV-2 , Estados Unidos , United States Food and Drug Administration , Vacunación
8.
Neurol Clin Pract ; 11(2): e83-e91, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33842075

RESUMEN

OBJECTIVE: To characterize the breadth of neurologic findings associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in a diverse group of inpatients at an urban, safety-net US medical center. METHODS: Patients were identified through an electronic medical record review from April 15, 2020, until July 1, 2020, at a large safety-net hospital in Boston, MA, caring primarily for underserved, low-income, and elderly patients. All hospitalized adult patients with positive nasopharyngeal swab or respiratory PCR testing for SARS-CoV-2 during their hospitalization or in the 30 days before admission who received an inpatient neurologic or neurocritical care consultation or admission during the study period were enrolled. RESULTS: Seventy-four patients were identified (42/57% male, median age 64 years). The majority of patients self-identified as Black or African American (38, 51%). The most common neurologic symptoms at presentation to the hospital included altered mental status (39, 53%), fatigue (18, 24%), and headache (18, 18%). Fifteen patients had ischemic strokes (20%). There were 10 in-hospital mortalities, with moderately severe disability among survivors at discharge (14%, median modified Rankin Scale score of 4). CONCLUSIONS: Neurologic findings spanned inflammatory, vascular pathologies, sequelae of critical illness and metabolic derangements, possible direct involvement of the nervous system by SARS-CoV-2, and exacerbation of underlying neurologic conditions, highlighting a broad range of possible etiologies of neurologic complications in patients with coronavirus disease 2019 (COVID-19). Further studies are needed to characterize the infectious and postinfectious neurologic complications of COVID-19 in diverse patient populations.

9.
Front Immunol ; 12: 614676, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33897682

RESUMEN

The COVID-19 pandemic has drastically impacted work, economy, and way of life. Sensitive measurement of SARS-CoV-2 specific antibodies would provide new insight into pre-existing immunity, virus transmission dynamics, and the nuances of SARS-CoV-2 pathogenesis. To date, existing SARS-CoV-2 serology tests have limited utility due to insufficient reliable detection of antibody levels lower than what is typically present after several days of symptoms. To measure lower quantities of SARS-CoV-2 IgM, IgG, and IgA with higher resolution than existing assays, we developed a new ELISA protocol with a distinct plate washing procedure and timed plate development via use of a standard curve. Very low optical densities from samples added to buffer coated wells at as low as a 1:5 dilution are reported using this 'BU ELISA' method. Use of this method revealed circulating SARS-CoV-2 receptor binding domain (RBD) and nucleocapsid protein (N) reactive antibodies (IgG, IgM, and/or IgA) in 44 and 100 percent of pre-pandemic subjects, respectively, and the magnitude of these antibodies tracked with antibody levels of analogous viral proteins from endemic coronavirus (eCoV) strains. The disease status (HIV, SLE) of unexposed subjects was not linked with SARS-CoV-2 reactive antibody levels; however, quantities were significantly lower in subjects over 70 years of age compared with younger counterparts. Also, we measured SARS-CoV-2 RBD- and N- specific IgM, IgG, and IgA antibodies from 29 SARS-CoV-2 infected individuals at varying disease states, including 10 acute COVID-19 hospitalized subjects with negative serology results by the EUA approved Abbott IgG chemiluminescent microparticle immunoassay. Measurements of SARS-CoV-2 RBD- and N- specific IgM, IgG, IgA levels measured by the BU ELISA revealed higher signal from 9 of the 10 Abbott test negative COVID-19 subjects than all pre-pandemic samples for at least one antibody specificity/isotype, implicating improved serologic identification of SARS-CoV-2 infection via multi-parameter, high sensitive antibody detection. We propose that this improved ELISA protocol, which is straightforward to perform, low cost, and uses readily available commercial reagents, is a useful tool to elucidate new information about SARS-CoV-2 infection and immunity and has promising implications for improved detection of all analytes measurable by this platform.


Asunto(s)
Envejecimiento/inmunología , Anticuerpos Antivirales/inmunología , Prueba Serológica para COVID-19 , COVID-19/inmunología , SARS-CoV-2/inmunología , Adulto , Anciano , Anciano de 80 o más Años , Envejecimiento/sangre , Anticuerpos Antivirales/sangre , COVID-19/sangre , Ensayo de Inmunoadsorción Enzimática , Femenino , Humanos , Masculino , Persona de Mediana Edad , SARS-CoV-2/metabolismo , Sensibilidad y Especificidad
10.
Med ; 2(4): 384-394, 2021 04 09.
Artículo en Inglés | MEDLINE | ID: mdl-33681831

RESUMEN

The coronavirus disease 2019 (COVID-19) pandemic has resulted in a concomitant deluge of medical, biological, and epidemiologic research. Clinicians are interested in incorporating the best new evidence-based practices when treating individuals with COVID-19 and instituting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission prevention protocols. However, without sufficient background knowledge, evaluating epidemiologic studies can be challenging, and failure to identify sources of bias could lead to poor treatment decisions. Here we provide a brief primer on key concepts and terms related to COVID-19 epidemiology to provide clinicians with a starting point for evaluating the emerging COVID-19 literature.


Asunto(s)
COVID-19 , Humanos , Pandemias/prevención & control , SARS-CoV-2
11.
Infect Control Hosp Epidemiol ; 42(11): 1307-1312, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-33583468

RESUMEN

OBJECTIVE: In response to the 2013-2016 Ebola virus disease outbreak, the US government designated certain healthcare institutions as Ebola treatment centers (ETCs) to better prepare for future emerging infectious disease outbreaks. This study investigated ETC experiences and critical care policies for patients with viral hemorrhagic fever (VHF). DESIGN: A 58-item questionnaire elicited information on policies for 9 critical care interventions, factors that limited care provision, and innovations developed to deliver care. SETTING AND PARTICIPANTS: The questionnaire was sent to 82 ETCs. METHODS: We analyzed ordinal and categorical data pertaining to the ETC characteristics and descriptive data about their policies and perceived challenges. Statistical analyses assessed whether ETCs with experience caring for VHF patients were more likely to have critical care policies than those that did not. RESULTS: Of the 27 ETCs who responded, 17 (63%) were included. Among them, 8 (47%) reported experience caring for persons under investigation or confirmed cases of VHF. Most felt ready to provide intubation, chest compressions, and renal replacement therapy to these patients. The factors most cited for limiting care were staff safety and clinical futility. Innovations developed to better provide care included increased simulation training and alternative technologies for procedures and communication. CONCLUSIONS: There were broad similarities in critical care policies and limitations among institutions. There were several interventions, namely ECMO and cricothyrotomy, which few institutions felt ready to provide. Future studies could identify obstacles to providing these interventions and explore policy changes after increased experience with novel infectious diseases, such as COVID-19.


Asunto(s)
COVID-19 , Fiebre Hemorrágica Ebola , Enfermedad Crítica , Brotes de Enfermedades , Fiebre Hemorrágica Ebola/epidemiología , Fiebre Hemorrágica Ebola/terapia , Humanos , Política Organizacional , SARS-CoV-2
12.
Lancet Infect Dis ; 21(6): 876-886, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33484646

RESUMEN

BACKGROUND: Lassa fever is endemic in several west African countries. Case-fatality rates ranging from 21% to 69% have been reported. The pathophysiology of the disease in humans and determinants of mortality remain poorly understood. We aimed to determine host protein biomarkers capable of determining disease outcome. METHODS: In this observational study, we analysed left-over blood samples from patients who tested positive for Lassa fever at Irrua Specialist Teaching Hospital, Nigeria, between January, 2014, and April, 2017. We measured viral load, concentrations of clinical chemistry parameters, and levels of 62 circulating proteins involved in inflammation, immune response, and haemostasis. Patients with a known outcome (survival or death) and at least 200 µL of good-quality diagnostic sample were included in logistic regression modelling to assess the correlation of parameters with Lassa fever outcome. Individuals who gave consent could further be enrolled into a longitudinal analysis to assess the association of parameters with Lassa fever outcome over time. Participants were divided into two datasets for the statistical analysis: a primary dataset (samples taken between Jan 1, 2014, and April 1, 2016), and a secondary dataset (samples taken between April 1, 2016, and April 1, 2017). Biomarkers were ranked by area under the receiver operating characteristic curve (AUC) from highest (most predictive) to lowest (least predictive). FINDINGS: Of 554 patients who tested positive for Lassa fever during the study period, 201 (131 in the primary dataset and 70 in the secondary dataset) were included in the biomarker analysis, of whom 74 (49 in the primary dataset and 25 in the secondary dataset) had died and 127 (82 in the primary dataset and 45 in the secondary dataset) had survived. Cycle threshold values (indicating viral load) and levels of 18 host proteins at the time of admission to hospital were significantly correlated with fatal outcome. The best predictors of outcome in both datasets were plasminogen activator inhibitor-1 (PAI-1; AUC 0·878 in the primary dataset and 0·876 in the secondary dataset), soluble thrombomodulin (TM; 0·839 in the primary dataset and 0·875 in the secondary dataset), and soluble tumour necrosis factor receptor superfamily member 1A (TNF-R1; 0·807 in the primary dataset and 0·851 in the secondary dataset), all of which had higher prediction accuracy than viral load (0·774 in the primary dataset and 0·837 in the secondary dataset). Longitudinal analysis (150 patients, of whom 36 died) showed that of the biomarkers that were predictive at admission, PAI-1 levels consistently decreased to normal levels in survivors but not in those who died. INTERPRETATION: The identification of PAI-1 and soluble TM as markers of fatal Lassa fever at admission, and of PAI-1 as a marker of fatal Lassa fever over time, suggests that dysregulated coagulation and fibrinolysis and endothelial damage have roles in the pathophysiology of Lassa fever, providing a mechanistic explanation for the association of Lassa fever with oedema and bleeding. These novel markers might aid in clinical risk stratification and disease monitoring. FUNDING: German Research Foundation, Leibniz Association, and US National Institutes of Health.


Asunto(s)
Biomarcadores/sangre , Fiebre de Lassa/diagnóstico , Fiebre de Lassa/mortalidad , Fiebre de Lassa/fisiopatología , Virus Lassa/aislamiento & purificación , Adulto , Anciano , Anciano de 80 o más Años , Humanos , Fiebre de Lassa/epidemiología , Modelos Logísticos , Masculino , Persona de Mediana Edad , Mortalidad , Nigeria/epidemiología , Tasa de Supervivencia , Carga Viral
14.
Int J Infect Dis ; 99: 28-33, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32721528

RESUMEN

OBJECTIVE: The aim of this observational study was to determine the optimal timing of interleukin-6 receptor inhibitor (IL6ri) administration for coronavirus disease 2019 (COVID-19). METHODS: Patients with COVID-19 were given an IL6ri (sarilumab or tocilizumab) based on iteratively reviewed guidelines. IL6ri were initially reserved for critically ill patients, but after review, treatment was liberalized to patients with lower oxygen requirements. Patients were divided into two groups: those requiring ≤45% fraction of inspired oxygen (FiO2) (termed stage IIB) and those requiring >45% FiO2 (termed stage III) at the time of IL6ri administration. The main outcomes were all-cause mortality, discharge alive from hospital, and extubation. RESULTS: A total of 255 COVID-19 patients were treated with IL6ri (149 stage IIB and 106 stage III). Patients treated in stage IIB had lower mortality than those treated in stage III (adjusted hazard ratio (aHR) 0.24, 95% confidence interval (CI) 0.08-0.74). Overall, 218 (85.5%) patients were discharged alive. Patients treated in stage IIB were more likely to be discharged (aHR 1.43, 95% CI 1.06-1.93) and were less likely to be intubated (aHR 0.43, 95% CI 0.24-0.79). CONCLUSIONS: IL6ri administration prior to >45% FiO2 requirement was associated with improved COVID-19 outcomes. This can guide clinical management pending results from randomized controlled trials.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Interleucina-6/antagonistas & inhibidores , Neumonía Viral/tratamiento farmacológico , COVID-19 , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/patología , Femenino , Humanos , Intubación Intratraqueal , Masculino , Persona de Mediana Edad , Pandemias , Alta del Paciente , Neumonía Viral/mortalidad , Neumonía Viral/patología , SARS-CoV-2 , Resultado del Tratamiento
15.
AAS Open Res ; 3: 3, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32500116

RESUMEN

The emergence of SARS-CoV-2 in China and transmission to more than 80 territories worldwide, including nine countries in Africa, presents a delicate situation for low-resource settings. Countries in Eastern and Central Africa have been on high alert since mid-2018 in anticipation of regional spread of the Ebola virus from the Democratic Republic of Congo. Significant investment has been made to support enhanced surveillance at point of entry and hospitals, infection control practices, clinical case management, and clinical research. With a new threat on the horizon, African countries have an opportunity to leverage the existing capacities for Ebola preparedness to brace for the imminent threat.

16.
Health Secur ; 18(2): 114-124, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32324070

RESUMEN

The West Africa Ebola virus disease outbreak of 2014-2016 demonstrated that responses to viral hemorrhagic fever epidemics must go beyond emergency stopgap measures and should incorporate high-quality medical care and clinical research. Optimal patient management is essential to improving outcomes, and it must be implemented regardless of geographical location or patient socioeconomic status. Coupling clinical research with improved care has a significant added benefit: Improved data quality and management can guide the development of more effective supportive care algorithms and can support regulatory approvals of investigational medical countermeasures (MCMs), which can alter the cycle of emergency response to reemerging pathogens. However, executing clinical research during outbreaks of high-consequence pathogens is complicated and comes with ethical and research regulatory challenges. Aggressive care and excellent quality control must be balanced by the requirements of an appropriate infection prevention and control posture for healthcare workers and by overcoming the resource limitations inherent in many outbreak settings. The Joint Mobile Emerging Disease Intervention Clinical Capability was established in 2015 to develop a high-quality clinical trial capability in Uganda to support rigorous evaluation of MCMs targeting high-consequence pathogens like Ebola virus. This capability assembles clinicians, laboratorians, clinical researchers, logisticians, and regulatory professionals trained in infection prevention and control and in good clinical and good clinical laboratory practices. The resulting team is prepared to provide high-quality medical care and clinical research during high-consequence outbreaks.


Asunto(s)
Ensayos Clínicos como Asunto/organización & administración , Brotes de Enfermedades/prevención & control , Fiebres Hemorrágicas Virales/prevención & control , Ensayos Clínicos como Asunto/métodos , Enfermedades Transmisibles Emergentes/prevención & control , Transmisión de Enfermedad Infecciosa/prevención & control , Fiebres Hemorrágicas Virales/terapia , Humanos , Uganda/epidemiología
18.
AMA J Ethics ; 22(1): E43-49, 2020 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-31958390

RESUMEN

Ethical and logistical challenges of deploying experimental vaccines in humanitarian emergencies are exacerbated by a paucity of safety and efficacy data. For outbreaks caused by pathogens with high mortality rates and few treatments, such as Ebola virus disease, not offering access to experimental vaccines with some evidence of efficacy can also be ethically suspect. This article recommends (1) gathering more preclinical data about experimental vaccines' safety and (2) improving research infrastructure to enable participation of a wide range of subjects in affected communities over long trial periods. Motivating these goals would facilitate clearer definitions of population vulnerability and risk acceptability.


Asunto(s)
Brotes de Enfermedades/ética , Urgencias Médicas , Accesibilidad a los Servicios de Salud/ética , Fiebre Hemorrágica Ebola/prevención & control , Seguridad del Paciente , Vacunación/ética , Vacunas , Altruismo , Aprobación de Drogas , Humanos , Sujetos de Investigación , Riesgo , Vacunas/efectos adversos , Poblaciones Vulnerables
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA
...