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1.
N Engl J Med ; 390(5): 397-408, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38294972

RESUMO

BACKGROUND: Butantan-Dengue Vaccine (Butantan-DV) is an investigational, single-dose, live, attenuated, tetravalent vaccine against dengue disease, but data on its overall efficacy are needed. METHODS: In an ongoing phase 3, double-blind trial in Brazil, we randomly assigned participants to receive Butantan-DV or placebo, with stratification according to age (2 to 6 years, 7 to 17 years, and 18 to 59 years); 5 years of follow-up is planned. The objectives of the trial were to evaluate overall vaccine efficacy against symptomatic, virologically confirmed dengue of any serotype occurring more than 28 days after vaccination (the primary efficacy end point), regardless of serostatus at baseline, and to describe safety up to day 21 (the primary safety end point). Here, vaccine efficacy was assessed on the basis of 2 years of follow-up for each participant, and safety as solicited vaccine-related adverse events reported up to day 21 after injection. Key secondary objectives were to assess vaccine efficacy among participants according to dengue serostatus at baseline and according to the dengue viral serotype; efficacy according to age was also assessed. RESULTS: Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or placebo (5976 participants). The overall 2-year vaccine efficacy was 79.6% (95% confidence interval [CI], 70.0 to 86.3) - 73.6% (95% CI, 57.6 to 83.7) among participants with no evidence of previous dengue exposure and 89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure. Vaccine efficacy was 80.1% (95% CI, 66.0 to 88.4) among participants 2 to 6 years of age, 77.8% (95% CI, 55.6 to 89.6) among those 7 to 17 years of age, and 90.0% (95% CI, 68.2 to 97.5) among those 18 to 59 years of age. Efficacy against DENV-1 was 89.5% (95% CI, 78.7 to 95.0) and against DENV-2 was 69.6% (95% CI, 50.8 to 81.5). DENV-3 and DENV-4 were not detected during the follow-up period. Solicited systemic vaccine- or placebo-related adverse events within 21 days after injection were more common with Butantan-DV than with placebo (58.3% of participants, vs. 45.6%). CONCLUSIONS: A single dose of Butantan-DV prevented symptomatic DENV-1 and DENV-2, regardless of dengue serostatus at baseline, through 2 years of follow-up. (Funded by Instituto Butantan and others; DEN-03-IB ClinicalTrials.gov number, NCT02406729, and WHO ICTRP number, U1111-1168-8679.).


Assuntos
Vacinas contra Dengue , Vírus da Dengue , Dengue , Vacinas Atenuadas , Adulto , Criança , Pré-Escolar , Humanos , Anticorpos Antivirais , Dengue/prevenção & controle , Vacinas contra Dengue/efeitos adversos , Vacinas contra Dengue/uso terapêutico , Vírus da Dengue/imunologia , Método Duplo-Cego , Vacinação , Vacinas , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/uso terapêutico , Brasil , Eficácia de Vacinas , Adolescente , Adulto Jovem , Pessoa de Meia-Idade , Seguimentos
2.
Artigo em Inglês | MEDLINE | ID: mdl-36613170

RESUMO

(1) Objectives: To evaluate the frequency and factors associated with the Post-COVID-19 Syndrome (PCS) in COVID-19 survivors after 3 and 6 months of hospital discharge; (2) Methods: We conducted a cohort study with patients who were hospitalized with COVID-19 in a referral public hospital in Brasília, Federal District, Brazil. After 3 and 6 months of discharge, patients answered a questionnaire about PCS symptoms. Poisson regression with robust variance was used to estimate the crude and adjusted prevalence ratios (PR and aPR) of PCS. (3) Results: The prevalence of PCS was 81% and 61% after 3 and 6 months of hospital discharge, respectively. The main symptoms after 3 months of discharge were hair loss (44%), fatigue (42%), and memory loss (39%); while after 6 months, they were memory loss (29%) and fatigue (27%). In the multivariate analysis, the main factor associated with PCS was female gender (aPR): 1.28 (1.16-1.41) and 1.60 (1.34-1.90), 3 and 6 months after hospital discharge, respectively. Hypercholesterolemia was also associated with PCS after 3 months aPR of 1.15 (1.04-1.27). After 6 months of discharge, obesity [aPR: 1.22 (1.03-1.45)] and pronation [aPR: 1.15 (1.06-1.25)] were relevant associated factors. (4) Conclusions: The prevalence of PCS was high in COVID-19 survivors who had the moderate and severe forms of the disease. Memory loss was the most persistent symptom. Our data pointed to female gender, hypercholesterolemia, obesity, and pronation during hospitalization as relevant PCS-associated risk factors.


Assuntos
COVID-19 , Hipercolesterolemia , Humanos , Feminino , Brasil/epidemiologia , Síndrome de COVID-19 Pós-Aguda , Estudos de Coortes , Prevalência , COVID-19/epidemiologia , Hospitalização , Fadiga , Hospitais Públicos , Obesidade , Transtornos da Memória
3.
Infection ; 51(2): 455-458, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35704257

RESUMO

PURPOSE: There is evidence that humans can transmit SARS-CoV-2 to cats and dogs. However, there is no evidence that they can transmit it back to humans or play any role in SARS-CoV-2 transmission. Here, we present an exploratory analysis on that matter. METHODS: We conducted a case-control study with participants with flu-like symptoms seeking care at a primary healthcare unit to be tested for COVID-19. They were asked if they owned pet cats and/or dogs in their residences, and this variable was evaluated as exposure. RESULTS: The odds ratio of "having dogs and/or cats in the residence" was 1.29 (95% CI 1.08-1.54) of "having only dogs and no cats" was 1.26 (1.05-1.52), and "no dogs and only cats" was 1.29 (0.95-1.75). CONCLUSION: Having a cat/dog in the house can affect the risk of infection by SARS-CoV-2.


Assuntos
COVID-19 , Doenças do Gato , Humanos , Animais , Gatos , SARS-CoV-2 , Estudos de Casos e Controles , Animais de Estimação , Doenças do Gato/epidemiologia
4.
Cien Saude Colet ; 27(7): 2679-2688, 2022 Jul.
Artigo em Português, Inglês | MEDLINE | ID: mdl-35730838

RESUMO

HIV exceptionalism refers to the fact that the illness is so different from other diseases that testing needs a special approach to informed consent. HIV infected people often visit health clinics, especially emergency departments, years before receiving a diagnosis without being tested for HIV. There is considerable public interest in increasing HIV testing in emergency departments. However, because these departments are sensitive environments that primarily provide urgent and emergency care, a number of ethical questions have been raised about the appropriateness of these settings for the implementation of universal screening programs. Human rights in patient care therefore constitutes an essential theoretical framework for analyzing ethical and legal dilemmas that arise in clinical encounters, thus strengthening the application of human rights principles to the context of patient care.


O "excepcionalismo" da infecção pelo HIV diz respeito ao fato de essa doença ser considerada tão diferente das demais e de que sua testagem necessita de uma abordagem especial em relação ao consentimento informado. Frequentemente, pessoas infectadas pelo HIV visitam unidades de assistência à saúde, sobretudo prontossocorros, anos antes de receberem um diagnóstico, sem terem sido testadas nessas oportunidades. Existe considerável interesse público em ampliar a testagem para o HIV em prontos-socorros. Por se tratar de ambiente sensível, cuja missão principal é o cuidado de urgências e emergências, há questionamentos quanto a esse ser um local apropriado para um programa de rastreamento universal, notadamente por questões éticas. Assim, os "direitos humanos dos pacientes" (DHP) constituem referencial teórico essencial para a análise de conflitos éticos que surgem no encontro clínico, fortalecendo a efetiva aplicação dos direitos humanos ao cuidado em saúde.


Assuntos
Infecções por HIV , Consentimento Livre e Esclarecido , Serviço Hospitalar de Emergência , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Teste de HIV , Humanos , Assistência ao Paciente
5.
Rev Soc Bras Med Trop ; 55: e03062021, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35416870

RESUMO

BACKGROUND: Guillian Barré syndrome (GBS) is an acute autoimmune polyradiculoneuropathy often associated with previous exposure to infectious agents. METHODS: A clinical cohort of 41 patients with GBS admitted to the Base Hospital Institute of the Federal District between May 2017 and April 2019 was followed up for 1 year. Serological tests for arbovirus detection and amplification of nucleic acids using polymerase chain reaction for zika virus (ZIKV), dengue virus (DENV), and chikungunya virus (CHIKV) were performed. RESULTS: The cohort consisted of 61% men with a median age of 40 years, and 83% had GBS-triggering events. A total of 54% had Grade 4 disability, 17% had Grade 3, 12% had Grade 2, 10% had Grade 5, and 7% had Grade 1. The classic form occurred in 83% of patients. Nerve conduction evaluations revealed acute demyelinating inflammatory polyneuropathy (51%), acute motor axonal neuropathy (17%), acute sensory-motor neuropathy (15%), and indeterminate forms (17%). Four patients were seropositive for DENV. There was no laboratory detection of ZIKV or CHIKV infection. Ninety percent of patients received human immunoglobulin. Intensive care unit admission occurred in 17.1% of the patients, and mechanical ventilation was used in 14.6%. One patient died of Bickerstaff's encephalitis. Most patients showed an improvement in disability at 10 weeks of follow-up. CONCLUSIONS: GBS in the Federal District showed a variable clinical spectrum, and it was possible to detect recent exposure to DENV.


Assuntos
Arbovírus , Síndrome de Guillain-Barré , Infecção por Zika virus , Zika virus , Adulto , Feminino , Síndrome de Guillain-Barré/complicações , Síndrome de Guillain-Barré/epidemiologia , Síndrome de Guillain-Barré/terapia , Humanos , Masculino , Centros de Atenção Terciária , Infecção por Zika virus/complicações , Infecção por Zika virus/diagnóstico , Infecção por Zika virus/epidemiologia
6.
Ciênc. Saúde Colet. (Impr.) ; 27(7): 2679-2688, 2022.
Artigo em Português | LILACS-Express | LILACS | ID: biblio-1384454

RESUMO

Resumo O "excepcionalismo" da infecção pelo HIV diz respeito ao fato de essa doença ser considerada tão diferente das demais e de que sua testagem necessita de uma abordagem especial em relação ao consentimento informado. Frequentemente, pessoas infectadas pelo HIV visitam unidades de assistência à saúde, sobretudo prontossocorros, anos antes de receberem um diagnóstico, sem terem sido testadas nessas oportunidades. Existe considerável interesse público em ampliar a testagem para o HIV em prontos-socorros. Por se tratar de ambiente sensível, cuja missão principal é o cuidado de urgências e emergências, há questionamentos quanto a esse ser um local apropriado para um programa de rastreamento universal, notadamente por questões éticas. Assim, os "direitos humanos dos pacientes" (DHP) constituem referencial teórico essencial para a análise de conflitos éticos que surgem no encontro clínico, fortalecendo a efetiva aplicação dos direitos humanos ao cuidado em saúde.


Abstract HIV exceptionalism refers to the fact that the illness is so different from other diseases that testing needs a special approach to informed consent. HIV infected people often visit health clinics, especially emergency departments, years before receiving a diagnosis without being tested for HIV. There is considerable public interest in increasing HIV testing in emergency departments. However, because these departments are sensitive environments that primarily provide urgent and emergency care, a number of ethical questions have been raised about the appropriateness of these settings for the implementation of universal screening programs. Human rights in patient care therefore constitutes an essential theoretical framework for analyzing ethical and legal dilemmas that arise in clinical encounters, thus strengthening the application of human rights principles to the context of patient care.

7.
Parasit Vectors ; 14(1): 610, 2021 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-34924014

RESUMO

BACKGROUND: Vector-borne diseases, especially arboviruses transmitted by Aedes sp. mosquitos, should be a health policy priority in Brazil. Despite this urgency, there are significant limitations in the traditional surveillance system, mainly in vulnerable areas. This study aimed to investigate the circulation of dengue (DENV), Zika (ZIKV), and chikungunya viruses (CHIKV) by laboratory syndromic surveillance (LSS) in a slum area of the Federal District of Brazil, comparing the results with traditional surveillance data. METHODS: LSS for acute febrile and/or exanthematous symptoms was developed at a health unit of Cidade Estrutural, in order to identify the circulation of arboviruses transmitted by Aedes sp. mosquitos. Between June 2019 and March 2020, 131 valid participants were identified and sera tested by reverse transcription polymerase chain reaction (RT-PCR) for DENV (by serotype), ZIKV, and CHIKV acute infection and by immunoglobulin M enzyme-inked immunosorbent assay (ELISA-IgM) for DENV and CHIKV 15-21 days after symptom onset, when the participant reported no respiratory signs (cough and/or coryza). The results obtained were compared with traditional surveillance data for the study area and period. RESULTS: At least three DENV-1 (2.3%), four DENV-2 (3%), and one CHIKV (0.7%) cases were confirmed in the laboratory, showing evidence of hyperendemicity even though LSS had not reached the historic peak dengue fever months in the Federal District (April-May). When the results obtained here were compared with traditional surveillance, a significant discrepancy was observed, including underreporting of CHIKV infection. CONCLUSIONS: In addition to the risks posed to the study population, the area investigated with its respective socio-environmental profile may be a potential site for spread of the virus, given the cosmopolitan presence of Aedes sp. and human mobility in the Federal District. It is also suggested that traditional epidemiological surveillance may be reporting acute viral infections other than DENV as dengue fever, while underreporting other arboviruses transmitted by Aedes sp. mosquitos in the Federal District.


Assuntos
Aedes/virologia , Infecções por Arbovirus/epidemiologia , Infecções por Arbovirus/virologia , Arbovírus/isolamento & purificação , Áreas de Pobreza , RNA Viral/isolamento & purificação , Animais , Brasil/epidemiologia , Humanos , Vigilância da População , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Fatores de Risco
8.
Arch Public Health ; 79(1): 89, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-34074325

RESUMO

BACKGROUND: Healthcare-associated infections (HAI) are important causes of neonatal morbidity and mortality in developing countries. We reviewed the incidence and the pathogens involved in HAI among infants admitted to neonatal intensive care units (NICU) in Brazil. METHODS: A search was conducted in the MEDLINE, LILACS and SciELO databases from January 1995 to October 2019. Two authors scrutinized potential articles independently, after one author selected them from screening abstracts from every article flagged as related to neonatal HAI. Then, they were included in the review if they met our inclusion criteria. The studies were evaluated based on a quality score proposed by the authors, rated 0 to 1, with 1 point as the best quality rate. Pooled estimates and 95% confidence intervals (95% CI) for HAI cumulative incidence and incidence density were calculated, when the same denominators were available, using meta-analysis. A quality effect was applied to the models using the MetaXL software. Heterogeneity was assessed using I2 statistics and the Cochran's Q test. RESULTS: Of a total of 5596 citations identified, 15 studies met the inclusion criteria for this review, which comprised 24,408 patients and 312,744 patient-days. Quality of the studies varied between 0.36 and 1 according to the adopted score, and six (40.0%) studies presented a score of 1. Pooled HAI incidence was 36.1 (95% CI 22.8-50.7) infections and 26.3 (95% CI 18.4-35.0) infected patients per 100 patients. Pooled HAI incidence density was 23.5 (95% CI 16.3-33.9) per 1000 patient-days. Pooled incidence density rates of bloodstream infection and ventilator-associated pneumonia were 13.1 per 1000 catheter-days (95% CI 4.3-40.1) and 7.9 per 1000 ventilator-days (95% CI 1.1-55.5), respectively. A high degree of heterogeneity was observed in all models (I2 > 98% and Cochran's Q test with p < 0.05). Coagulase-negative Staphylococci (32.1%), Staphylococcus aureus (13.8%) and Klebsiella spp. (12.4%) were the most prevalent causative bacterial pathogens. CONCLUSIONS: The findings show high incidence of neonatal HAI in Brazilian NICU; therefore, efforts to standardize the collection and notification of HAI are needed in order to strengthen surveillance in the country and implement preventive measures, routine assessment, and close monitoring of neonates.

9.
Clin Infect Dis ; 72(9): e373-e381, 2021 05 04.
Artigo em Inglês | MEDLINE | ID: mdl-32785710

RESUMO

BACKGROUND: Steroid use for coronavirus disease 2019 (COVID-19) is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19. METHODS: A parallel, double-blind, placebo-controlled, randomized, Phase IIb clinical trial was performed with hospitalized patients aged ≥18 years with clinical, epidemiological, and/or radiological suspected COVID-19 at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution) twice daily for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. RESULTS: From 18 April to 16 June 2020, 647 patients were screened, 416 were randomized, and 393 were analyzed as mITT, with 194 individuals assigned to MP and 199 to placebo. SARS-CoV-2 infection was confirmed by reverse transcriptase polymerase chain reaction in 81.3%. The mortality rates at Day 28 were not different between groups. A subgroup analysis showed that patients over 60 years old in the MP group had a lower mortality rate at Day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until Day 7. CONCLUSIONS: The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population. CLINICAL TRIALS REGISTRATION: NCT04343729.


Assuntos
COVID-19 , Adolescente , Adulto , Brasil , Método Duplo-Cego , Humanos , Metilprednisolona/uso terapêutico , Pessoa de Meia-Idade , SARS-CoV-2 , Resultado do Tratamento
11.
Rev Soc Bras Med Trop ; 53: e20200007, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32935778

RESUMO

INTRODUCTION: It is believed that delays in diagnosis and treatment of Visceral Leishmaniasis (VL) contribute significantly to the burden of VL lethality in Brazil. METHODS: This study included several parts: a descriptive cross-sectional study of the individual characteristics of deaths from disease; a descriptive ecological study of the spatial distribution of deaths from disease; and an ecological analytical study to evaluate the association between disease lethality rates and the demographic, socioeconomic, and health indicators. The study population comprised all cases diagnosed throughout the country per the National Disease Notification System (SINAN) and the total number of disease deaths recorded in the Mortality Information System (SIM) from 2007 to 2012. RESULTS: Of the 223 deaths from disease captured by pairing the databases, 59.1% were reported as "death from other causes". There were significant associations between VL lethality rate and municipalities with the highest proportion of vulnerable individuals (rate ratio (RR)=1.18, 95% confidence interval (CI): 1.01-1.27), with VL lower incidence rate (RR=0.62, 95% CI: 0.58-0.67) and a higher incidence rate of Acquired Immune Deficiency Syndrome (AIDS) (RR=1.20, 95% CI: 1.17-1.51). CONCLUSIONS: Linking the SINAN and SIM databases allowed the inclusion of 14% of otherwise underreported deaths from VL for the study period, showing that this method is useful for the surveillance of VL-related deaths. The size of the municipal population, proportion of the vulnerable population, incidence of disease, and the incidence of AIDS were associated with municipal lethality rates related to VL in Brazil.


Assuntos
Leishmaniose Visceral , Adolescente , Adulto , Idoso , Brasil , Criança , Pré-Escolar , Estudos Transversais , Humanos , Incidência , Lactente , Pessoa de Meia-Idade , Fatores Socioeconômicos , Adulto Jovem
12.
Trop Med Int Health ; 25(10): 1168-1181, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32677284

RESUMO

OBJECTIVES: To analyse the accuracy of American tegumentary leishmaniasis (ATL) diagnostic methods and evaluate the quality of the existing publications by means of a systematic review. METHODS: Diagnostic tests evaluated in at least two studies with common reference standards were included in the sensitivity and/or specificity meta-analyses. Quality and susceptibility to bias were analysed using the QUADAS-2 and STARD tools. RESULTS: The title and abstract of 3387 publications were evaluated after deduplication resulting from database searches. Thirty-eight studies were included in the review, and 26 of them had results inserted in meta-analyses. The diagnostic methods with the highest pooled sensitivity values were ELISA, polymerase chain reaction (PCR), indirect immunofluorescence reaction and Montenegro's intradermal reaction. Cytometry was assessed in only two studies and presented 100% sensitivity in both. Smear slide microscopy and histopathology showed low pooled values of sensitivity. For specificity, the highest pooled values were identified for PCR. High values were also identified for ELISA, except for studies in which the reference standard for defining negative participants included individuals with Chagas' disease or paracoccidioidomycosis, which also occurred for cytometry. IFR had lower specificities than ELISA. There was a predominance of case-control designs of phase 1 or 2 and only four studies were strongly recommended as evidence generators. Several reference standards were adopted, and different methods were assessed in a small number of studies. CONCLUSION: PCR showed the highest accuracy for the diagnosis of ATL, and its use should be encouraged in clinical practice. ELISA is recommended for the screening of suspected individuals, but the possibility of cross-reactions should be considered. New validation studies for the tests evaluated in few publications and studies of phase 3 with appropriate methods are needed.


OBJECTIFS: Analyser l'exactitude des méthodes de diagnostic de la leishmaniose tégumentaire américaine (LTA) et évaluer la qualité des publications existantes au moyen d'une analyse systématique. MÉTHODES: Les tests diagnostiques évalués dans au moins deux études avec des étalons de référence communs ont été inclus dans les méta-analyses de sensibilité et/ou de spécificité. La qualité et la sensibilité au biais ont été analysées à l'aide des outils QUADAS-2 et STARD. RÉSULTATS: Le titre et le résumé de 3387 publications ont été évalués après déduplication résultant de recherches dans la base de données. 38 études ont été incluses dans la revue et 26 d'entre elles ont eu des résultats inclus dans des méta-analyses. Les méthodes de diagnostic avec les valeurs de sensibilité poolées les plus élevées étaient ELISA, la réaction en chaîne par polymérase (PCR), la réaction d'immunofluorescence indirecte et la réaction intradermique du Monténégro. La cytométrie a été évaluée dans seulement deux études et présentait une sensibilité de 100% dans les deux. La microscopie et l'histopathologie sur lame de frottis ont montré de faibles valeurs poolées de sensibilité. Pour la spécificité, les valeurs poolées les plus élevées ont été identifiées pour la PCR. Des valeurs élevées ont également été identifiées pour l'ELISA, à l'exception des études dans lesquelles la norme de référence pour définir les participants négatifs incluait des individus atteints de la maladie de Chagas ou de paracoccidioïdomycose, qui s'est également produite pour la cytométrie. L'IFR avait des spécificités plus faibles que l'ELISA. Il y avait une prédominance des essais cas-témoins de phases 1 ou 2 et seules quatre études étaient fortement recommandées comme génératrices de preuves. Plusieurs normes de référence ont été adoptées et différentes méthodes ont été évaluées dans un petit nombre d'études. CONCLUSION: la PCR a montré la plus grande exactitude pour le diagnostic de l'ATL et son utilisation doit être encouragée dans la pratique clinique. L'ELISA est recommandé pour le dépistage des personnes suspectées, mais la possibilité de réactions croisées doit être considérée. De nouvelles études de validation des tests évalués dans quelques publications et des études de phase 3 avec des méthodes appropriées sont nécessaires.


Assuntos
Leishmania/isolamento & purificação , Leishmaniose Cutânea/diagnóstico , Animais , Testes Diagnósticos de Rotina , Ensaio de Imunoadsorção Enzimática , Humanos , Leishmania/genética , América do Norte , Reação em Cadeia da Polimerase , Sensibilidade e Especificidade , América do Sul
13.
JAMA Netw Open ; 3(4): e208857, 2020 04 24.
Artigo em Inglês | MEDLINE | ID: mdl-32330277

RESUMO

Importance: There is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug. Objective: To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19. Design, Setting, and Participants: This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon. Interventions: Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days). Main Outcomes and Measures: Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4. Results: Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to high-dosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%). Conclusions and Relevance: The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir. These findings cannot be extrapolated to patients with nonsevere COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04323527.


Assuntos
Antivirais/uso terapêutico , Cloroquina/análogos & derivados , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Adulto , Idoso , Antibacterianos/uso terapêutico , Antivirais/administração & dosagem , Antivirais/efeitos adversos , Azitromicina/uso terapêutico , Betacoronavirus , Brasil , COVID-19 , Cloroquina/administração & dosagem , Cloroquina/efeitos adversos , Cloroquina/uso terapêutico , Surtos de Doenças , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Oseltamivir/uso terapêutico , Pandemias , SARS-CoV-2 , Centros de Atenção Terciária
14.
Mem Inst Oswaldo Cruz ; 115: e190349, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32348406

RESUMO

BACKGROUND: Visceral leishmaniasis (VL) is relevant for human and animal public health. Several factors have been associated with the risk of Leishmania infantum infection in dogs. However, dog owner characteristics have been rarely explored. OBJECTIVES: To estimate the prevalence and to identify the associated factors for VL infection including dog owners characteristics. METHODS: A cross-sectional study was conducted including dogs from an endemic canine visceral leishmaniasis (CVL) region in the Federal District, Brazil. The infection was detected using parasitological, serological, and molecular methods. The associated factors were identified through Poisson regression modelling. FINDINGS: The prevalence of infection was 26.25% [95% confidence interval (CI): 20.05 to 33.57]. The associated factors were: short coat prevalence ratio (PR) = 2.33 (95% CI: 1.02 to 5.22); presence of backyard with predominance of soil and/or vegetation PR = 4.15 (95% CI: 1.35 to 12.77); and highest gross family income score PR = 2.03 (95% CI: 1.16 to 3.54). MAIN CONCLUSION: This is the first study that relates higher socioeconomic status of dog owners as an independent factor associated with higher prevalence of VL infection, along with other strongly associated factors related to receptive environment for phlebotomines. Our findings strengthen the need for exploration of the biological and behavioural bases linking dog owner characteristics to the risk of canine infection in prospective cohort studies.


Assuntos
Doenças do Cão/epidemiologia , Leishmaniose Visceral/veterinária , Animais , Brasil/epidemiologia , Estudos Transversais , Doenças do Cão/diagnóstico , Cães , Ensaio de Imunoadsorção Enzimática/veterinária , Feminino , Humanos , Leishmaniose Visceral/diagnóstico , Leishmaniose Visceral/epidemiologia , Masculino , Prevalência , Estudos Prospectivos , Fatores de Risco , Fatores Socioeconômicos
15.
Rev Soc Bras Med Trop ; 53: e20190117, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31994656

RESUMO

INTRODUCTION: This study intends to describe a HIV intake screening strategy in recently incarcerated adults in Distrito Federal, Brasilia, Brazil. METHODS: We tested 455 recently incarcerated adults in Distrito Federal in 2016 using rapid tests (RT) applied to oral samples (OS). RESULTS: The estimated frequency of positive tests was 0.88% (95% confidence interval [CI] 0.34% to 2.24%). CONCLUSIONS: The present findings reveal the potential significance of detecting new HIV infection cases in a vulnerable population using point-of-care rapid diagnostic tests.


Assuntos
Infecções por HIV/diagnóstico , Prisioneiros/estatística & dados numéricos , Adolescente , Adulto , Brasil/epidemiologia , Feminino , Infecções por HIV/epidemiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Prevalência , Kit de Reagentes para Diagnóstico , Adulto Jovem
16.
Rev. Soc. Bras. Med. Trop ; 53: e20200007, 2020. tab, graf
Artigo em Inglês | Sec. Est. Saúde SP, Coleciona SUS, LILACS | ID: biblio-1136827

RESUMO

Abstract INTRODUCTION: It is believed that delays in diagnosis and treatment of Visceral Leishmaniasis (VL) contribute significantly to the burden of VL lethality in Brazil. METHODS: This study included several parts: a descriptive cross-sectional study of the individual characteristics of deaths from disease; a descriptive ecological study of the spatial distribution of deaths from disease; and an ecological analytical study to evaluate the association between disease lethality rates and the demographic, socioeconomic, and health indicators. The study population comprised all cases diagnosed throughout the country per the National Disease Notification System (SINAN) and the total number of disease deaths recorded in the Mortality Information System (SIM) from 2007 to 2012. RESULTS: Of the 223 deaths from disease captured by pairing the databases, 59.1% were reported as "death from other causes". There were significant associations between VL lethality rate and municipalities with the highest proportion of vulnerable individuals (rate ratio (RR)=1.18, 95% confidence interval (CI): 1.01-1.27), with VL lower incidence rate (RR=0.62, 95% CI: 0.58-0.67) and a higher incidence rate of Acquired Immune Deficiency Syndrome (AIDS) (RR=1.20, 95% CI: 1.17-1.51). CONCLUSIONS: Linking the SINAN and SIM databases allowed the inclusion of 14% of otherwise underreported deaths from VL for the study period, showing that this method is useful for the surveillance of VL-related deaths. The size of the municipal population, proportion of the vulnerable population, incidence of disease, and the incidence of AIDS were associated with municipal lethality rates related to VL in Brazil.


Assuntos
Humanos , Lactente , Pré-Escolar , Criança , Adolescente , Adulto , Idoso , Adulto Jovem , Leishmaniose Visceral , Fatores Socioeconômicos , Brasil , Incidência , Estudos Transversais , Pessoa de Meia-Idade
17.
Rev. Soc. Bras. Med. Trop ; 53: e20190117, 2020. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1057297

RESUMO

Abstract INTRODUCTION: This study intends to describe a HIV intake screening strategy in recently incarcerated adults in Distrito Federal, Brasilia, Brazil. METHODS: We tested 455 recently incarcerated adults in Distrito Federal in 2016 using rapid tests (RT) applied to oral samples (OS). RESULTS: The estimated frequency of positive tests was 0.88% (95% confidence interval [CI] 0.34% to 2.24%). CONCLUSIONS: The present findings reveal the potential significance of detecting new HIV infection cases in a vulnerable population using point-of-care rapid diagnostic tests.


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Adulto Jovem , Prisioneiros/estatística & dados numéricos , Infecções por HIV/diagnóstico , Kit de Reagentes para Diagnóstico , Brasil/epidemiologia , Infecções por HIV/epidemiologia , Prevalência , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade
18.
Mem. Inst. Oswaldo Cruz ; 115: e190349, 2020. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1101273

RESUMO

BACKGROUND Visceral leishmaniasis (VL) is relevant for human and animal public health. Several factors have been associated with the risk of Leishmania infantum infection in dogs. However, dog owner characteristics have been rarely explored. OBJECTIVES To estimate the prevalence and to identify the associated factors for VL infection including dog owners characteristics. METHODS A cross-sectional study was conducted including dogs from an endemic canine visceral leishmaniasis (CVL) region in the Federal District, Brazil. The infection was detected using parasitological, serological, and molecular methods. The associated factors were identified through Poisson regression modelling. FINDINGS The prevalence of infection was 26.25% [95% confidence interval (CI): 20.05 to 33.57]. The associated factors were: short coat prevalence ratio (PR) = 2.33 (95% CI: 1.02 to 5.22); presence of backyard with predominance of soil and/or vegetation PR = 4.15 (95% CI: 1.35 to 12.77); and highest gross family income score PR = 2.03 (95% CI: 1.16 to 3.54). MAIN CONCLUSION This is the first study that relates higher socioeconomic status of dog owners as an independent factor associated with higher prevalence of VL infection, along with other strongly associated factors related to receptive environment for phlebotomines. Our findings strengthen the need for exploration of the biological and behavioural bases linking dog owner characteristics to the risk of canine infection in prospective cohort studies.


Assuntos
Humanos , Animais , Masculino , Feminino , Cães , Doenças do Cão/epidemiologia , Leishmaniose Visceral/veterinária , Fatores Socioeconômicos , Brasil/epidemiologia , Ensaio de Imunoadsorção Enzimática/veterinária , Prevalência , Estudos Transversais , Estudos Prospectivos , Fatores de Risco , Doenças do Cão/diagnóstico , Leishmaniose Visceral/diagnóstico , Leishmaniose Visceral/epidemiologia
19.
Trop Med Int Health ; 24(9): 1064-1077, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31278808

RESUMO

OBJECTIVE: To estimate the cost-effectiveness of strategies for the treatment of VL in Brazil. METHODS: Cost-effectiveness study comparing three therapeutic options: meglumine antimoniate (MA), liposomal amphotericin B (LAMB) and a combination of LAMB plus MA (LAMB plus MA), from public health system and societal perspectives. An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days. The efficacy and safety parameters of the drugs came from a randomised, open-label trial and the cost data came from a cost-of-illness study, both carried out in Brazil. RESULTS: For all outcomes analysed, the LAMB strategy was more effective. The MA strategy was inferior to the LAMB plus MA strategy for the outcomes early therapeutic failure avoided and cure. When only LAMB and MA were compared from a societal perspective, a cost of US$ 278.56 was estimated for each additional early therapeutic failure avoided, a cost of US$ 26.88 for each additional day of hospitalisation avoided and a cost of US$ 89.88 for each additional case of cured VL, for the LAMB strategy vs. MA. CONCLUSION: In Brazil, the LAMB strategy proved to be cost-effective for treating VL, considering a GDP per capita as the willingness-to-pay threshold, for all of the outcomes analysed in comparison to MA.


OBJECTIF: Estimer la rentabilité des stratégies de traitement de la leishmaniose viscérale (LV) au Brésil. MÉTHODES: Etude coût-efficacité comparant trois options thérapeutiques: l'antimoniate de méglumine (AM), amphotéricine B liposomale (LAMB) et une combinaison de LAMB et MA (LAMB plus AM), du point de vue du système de santé publique et sociétal. Un modèle décisionnel analytique a été utilisé pour comparer les stratégies pour les résultats suivants: échec thérapeutique précoce évité à 30 jours, jours d'hospitalisation évités et guérison de la LV à 180 jours. Les paramètres d'efficacité et de sécurité des médicaments provenaient d'un essai randomisé ouvert et les données relatives aux coûts, d'une étude sur le coût de la maladie, toutes deux menées au Brésil. RÉSULTATS: Pour tous les résultats analysés, la stratégie LAMB était plus efficace. La stratégie AM était inférieure à la stratégie LAMB plus AM pour les résultats: échec thérapeutique précoce évité et guérison. Lorsque seules les stratégies LAMB et AM ont été comparées d'un point de vue sociétal, un coût de 278,56 USD a été estimé pour chaque échec thérapeutique précoce additionnel évité, un coût de 26,88 USD pour chaque jour d'hospitalisation additionnel évité et un coût de 89,88 USD pour chaque cas additionnel de LV guéri, pour la stratégie LAMB par rapport à AM. CONCLUSION: Au Brésil, la stratégie LAMB s'est avérée rentable pour traiter la LV, considérant un PIB par habitant comme seuil de volonté de payer, pour tous les résultats analysés par rapport à l'AM.


Assuntos
Anfotericina B/economia , Anfotericina B/uso terapêutico , Antiprotozoários/uso terapêutico , Leishmaniose Visceral/tratamento farmacológico , Antimoniato de Meglumina/economia , Antimoniato de Meglumina/uso terapêutico , Anfotericina B/administração & dosagem , Antiprotozoários/economia , Brasil , Análise Custo-Benefício , Quimioterapia Combinada , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Antimoniato de Meglumina/administração & dosagem , Modelos Econométricos
20.
Trans R Soc Trop Med Hyg ; 113(5): 252-258, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30892628

RESUMO

BACKGROUND: Guillain-Barré syndrome (GBS) is a serious, acute paralytic neuropathy of autoimmune aetiology, usually associated with a previous infection. The current study aims to estimate the costs of GBS associated with Zika virus (ZIKV) infection in Brazil. METHODS: A cost-of-illness study was conducted from the perspective of the Brazilian public health system (Sistema Único de Saúde [SUS]) and Brazilian society for the year 2016. Direct and indirect costs were estimated by a mixed macrocosting and microcosting approach. RESULTS: The total cost of ZIKV-associated GBS in Brazil was US$11 997 225.85, consisting of the costs of symptomatic ZIKV infection before onset of GBS (direct costs US$2011.51, indirect costs US$19 780.53) and the costs that followed development of GBS (direct costs US$4 722 980.89, indirect costs US$7 252 452.92). The cost of treatment with human immunoglobulin (US$3 263 210.50) and the cost of productivity losses associated with potential years of working life lost due to early mortality (US$4 398 551.72) were particularly noteworthy. CONCLUSIONS: These findings suggest that ZIKV-associated GBS is costly to Brazil, especially due to productivity losses and hospitalization. This highlights the importance of investing in the prevention of ZIKV infection and in the care of patients with GBS.


Assuntos
Síndrome de Guillain-Barré/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Infecção por Zika virus/economia , Adulto , Brasil , Efeitos Psicossociais da Doença , Feminino , Síndrome de Guillain-Barré/complicações , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Zika virus , Infecção por Zika virus/complicações
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