ABSTRACT
Resumo Fundamento Apesar da necessidade de opções terapêuticas específicas para a doença do coronavírus 2019 (covid-19), ainda não há evidências da eficácia de tratamentos específicos no contexto ambulatorial. Há poucos estudos randomizados que avaliam a hidroxicloroquina (HCQ) em pacientes não hospitalizados. Esses estudos não indicaram benefício com o uso da HCQ; no entanto, avaliaram desfechos primários diferentes e apresentaram vieses importantes na avaliação dos desfechos. Objetivo Investigar se a HCQ possui o potencial de prevenir hospitalizações por covid-19 quando comparada ao placebo correspondente. Métodos O estudo COVID-19 Outpatient Prevention Evaluation (COPE) é um ensaio clínico randomizado, pragmático, duplo-cego, multicêntrico e controlado por placebo que avalia o uso da HCQ (800 mg no dia 1 e 400 mg do dia 2 ao dia 7) ou placebo correspondente na prevenção de hospitalizações por covid-19 em casos precoces confirmados ou suspeitos de pacientes não hospitalizados. Os critérios de inclusão são adultos (≥ 18 anos) que procuraram atendimento médico com sintomas leves de covid-19, com randomização ≤ 7 dias após o início dos sintomas, sem indicação de hospitalização na triagem do estudo e com pelo menos um fator de risco para complicações (> 65 anos, hipertensão, diabetes melito, asma, doença pulmonar obstrutiva crônica ou outras doenças pulmonares crônicas, tabagismo, imunossupressão ou obesidade). Todos os testes de hipótese serão bilaterais. Um valor de p < 0,05 será considerado estatisticamente significativo em todas as análises. Clinicaltrials.gov: NCT04466540. Resultados Os desfechos clínicos serão avaliados centralmente por um comitê de eventos clínicos independente cegado para a alocação dos grupos de tratamento. O desfecho primário de eficácia será avaliado de acordo com o princípio da intenção de tratar. Conclusão Este estudo apresenta o potencial de responder de forma confiável a questão científica do uso da HCQ em pacientes ambulatoriais com covid-19. Do nosso conhecimento, este é o maior estudo avaliando o uso de HCQ em indivíduos com covid-19 não hospitalizados.
Abstract Background Despite the need for targeting specific therapeutic options for coronavirus disease 2019 (COVID-19), there has been no evidence of effectiveness of any specific treatment for the outpatient clinical setting. There are few randomized studies evaluating hydroxychloroquine (HCQ) in non-hospitalized patients. These studies indicate no benefit from the use of HCQ, but they assessed different primary outcomes and presented important biases for outcome evaluation. Objective To evaluate if HCQ may prevent hospitalization due to COVID-19 compared to a matching placebo. Methods The COVID-19 Outpatient Prevention Evaluation (COPE) study is a pragmatic, randomized, double-blind, placebo-controlled clinical trial evaluating the use of HCQ (800 mg on day 1 and 400 mg from day 2 to day 7) or matching placebo for the prevention of hospitalization due to COVID-19 in early non-hospitalized confirmed or suspected cases. Inclusion criteria are adults (≥ 18 years) seeking medical care with mild symptoms of COVID-19, with randomization ≤ 7 days after symptom onset, without indication of hospitalization at study screening, and with at least one risk factor for complication (> 65 years; hypertension; diabetes mellitus; asthma; chronic obstructive pulmonary disease or other chronic lung diseases; smoking; immunosuppression; or obesity). All hypothesis tests will be two-sided. A p-value < 0.05 will be considered statistically significant in all analyses. Clinicaltrials.gov: NCT04466540. Results Clinical outcomes will be centrally adjudicated by an independent clinical event committee blinded to the assigned treatment groups. The primary efficacy endpoint will be assessed following the intention-to-treat principle. Conclusion This study has the potential to reliably answer the scientific question of HCQ use in outpatients with COVID-19. To our knowledge, this is the largest trial evaluating HCQ in non-hospitalized individuals with COVID-19.
Subject(s)
Humans , Adult , COVID-19/drug therapy , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Outpatients , Treatment Outcome , SARS-CoV-2ABSTRACT
ABSTRACT Introduction: Use of antibiotic and bacterial resistance is the result of a complex interaction not completely understood. Objectives: To evaluate the impact of entire antimicrobial use (community plus hospitals) on the incidence of bloodstream infections in intensive care units adjusted by socioeconomic factors, quality of healthcare, and access to the healthcare system. Design: Ecologic study using a hierarchical spatial model. Setting: Data obtained from 309 hospitals located in the state of São Paulo, Brazil from 2008 to 2011. Participants: Intensive care units located at participant hospitals. Outcome: Hospital acquired bloodstream infection caused by MDRO in ICU patients was our primary outcome and data were retrieved from São Paulo Health State Department. Socioeconomic and healthcare indexes data were obtained from IBGE (Brazilian Foundation in charge of national decennial census) and SEADE (São Paulo Planning and Development Department). Information on antimicrobial sales were obtained from IMS Brazil. We divided antibiotics into four different groups (1-4). Results: We observed a direct association between the use of group 1 of antibiotics and the incidences of bloodstream infections caused by MRSA (1.12; 1.04-1.20), and CR-Acinetobacter sp. (1.19; 1.10-1.29). Groups 2 and 4 were directly associated to VRE (1.72; 1.13-2.39 and 2.22; 1.62-2.98, respectively). Group 2 was inversely associated to MRSA (0.87; 0.78-0.96) and CR-Acinetobacter sp. (0.79; 0.62-0.97). Group 3 was inversely associated to Pseudomonas aeruginosa (0.69; 0.45-0.98), MRSA (0.85; 0.72-0.97) and VRE (0.48; 0.21-0.84). No association was observed for third generation cephalosporin-resistant Klebsiella pneumoniae and Escherichia coli. Conclusions: The association between entire antibiotic use and resistance in ICU was poor and not consistent for all combinations of antimicrobial groups and pathogens even after adjusted by socioeconomic indexes. Selective pressure exerted at the community level seemed not to affect the incidences of MDRO infection observed in intensive care setting.
Subject(s)
Humans , Cross Infection , Anti-Bacterial Agents , Brazil/epidemiology , Cross Infection/drug therapy , Cross Infection/epidemiology , Drug Resistance, Bacterial , Hospitals , Intensive Care Units , Anti-Bacterial Agents/pharmacologyABSTRACT
Aim: The objective was to describe an outbreak of bloodstream infections by Burkholderia cepacia complex (Bcc) in bone marrow transplant and hematology outpatients. Methods: On February 15, 2008 a Bcc outbreak was suspected. 24 cases were identified. Demographic and clinical data were evaluated. Environment and healthcare workers' (HCW) hands were cultured. Species were determined and typed. Reinforcement of hand hygiene, central venous catheter (CVC) care, infusion therapy, and maintenance of laminar flow cabinet were undertaken. 16 different HCWs had cared for the CVCs. Multi-dose heparin and saline were prepared on counter common to both units. Findings: 14 patients had B. multivorans (one patient had also B. cenopacia), six non-multivorans Bcc and one did not belong to Bcc. Clone A B. multivorans occurred in 12 patients (from Hematology); in 10 their CVC had been used on February 11/12. Environmental and HCW cultures were negative. All patients were treated with meropenem, and ceftazidime lock-therapy. Eight patients (30%) were hospitalized. No deaths occurred. After control measures (multidose vial for single patient; CVC lock with ceftazidime; cleaning of laminar flow cabinet; hand hygiene improvement; use of cabinet to store prepared medication), no new cases occurred. Conclusions: This polyclonal outbreak may be explained by a common source containing multiple species of Bcc, maybe the laminar flow cabinet common to both units. There may have been contamination by B. multivorans (clone A) of multi-dose vials.
O objetivo foi descrever um surto de infecções da corrente sanguínea por complexo B. cepacia (Bcc) nos ambulatórios de hematologia e transplante de medula óssea. Métodos: Em 15/02/2008, um surto de Bcc foi suspeitado. 24 casos foram identificados. Os dados demográficos e clínicos foram avaliados. Mãos de profissionais da saúde e ambiente foram cultivadas. Espécies foram determinadas e tipadas. Reforço da higiene das mãos, cuidados com cateteres, terapia de infusão e manutenção da câmara de fluxo laminar foram realizadas. 16 profissionais de saúde (PS) diferentes manipularam os cateteres. Heparina multidoses e soro eram preparadas em um balcão comum a ambas as unidades. Resultados: 14 pacientes tiveram B. multivorans (um paciente teve também B. cenopacia), 6 Bcc não-multivorans e um teve um agente não pertencente a Bcc. Clone A de B. multivorans ocorreu em 12 pacientes (da Hematologia), em 10 o cateter havia sido utilizado nos dias 11 ou 12 de fevereiro. Culturas ambientais e de PS foram negativos. Todos os pacientes foram tratados com meropenem e selo de ceftazidima. Oito pacientes (30%) foram hospitalizados. Não ocorreram mortes. Após as medidas de controle, nenhum novo caso ocorreu. Conclusões: Este surto policlonal pode ser explicado por uma fonte comum contendo várias espécies de Bcc, talvez a câmara de fluxo laminar comum a ambas as unidades. Pode ter havido contaminação por B. multivorans (clone A) de frascos multi-dose.
Subject(s)
Adolescent , Adult , Child , Child, Preschool , Female , Humans , Male , Middle Aged , Young Adult , Bacteremia/microbiology , Burkholderia Infections/microbiology , Burkholderia cepacia complex/isolation & purification , Catheter-Related Infections/microbiology , Disease Outbreaks , Bone Marrow Transplantation , Bacteremia/epidemiology , Burkholderia Infections/epidemiology , Catheter-Related Infections/epidemiology , Hematologic DiseasesABSTRACT
Surveillance systems for healthcare-associated infections (HAI) are essential for planning actions in prevention and control. Important models have been deployed in recent decades in different countries. This study aims to present the historical and operational characteristics of these systems and discuss the challenges for Brazil. Various models around the world have drawn on the experience of the United States, which pioneered this process. In Brazil, several initiatives have been launched, but the country still lacks a full national information system on HAI, thus indicating the need to promote action strategies, strengthen the role of States in communication between the Federal and local levels, pursue a national plan to organize surveillance teams with the necessary technological infrastructure, besides updating the relevant legislation for dealing with these challenges. Such measures are essential in the Brazilian context for the unified surveillance of HAI, aimed at healthcare safety and quality.
A formação de sistemas de vigilância de infecções relacionadas à assistência à saúde (IRAS) é medida essencial para o planejamento de ações de prevenção e controle. No mundo, importantes modelos estão sendo implantados nas últimas décadas. Este estudo busca apresentar os aspectos históricos e operacionais desses sistemas, discutindo os desafios para o Brasil. Os modelos internacionais se espelham no exemplo americano, pioneiro nesse processo. No Brasil, diversas iniciativas foram e estão sendo estabelecidas, entretanto, não temos um pleno sistema nacional de informação sobre IRAS, o que aponta a necessidade de reconhecer estratégias em vigência, fortalecendo o Estado como elo de comunicação; buscando um plano nacional para a formação de equipes de vigilância com aparato tecnológico necessário, e discutindo a atualização das legislações que já não contemplam os desafios atuais de tais ocorrências. Essas são medidas essenciais no contexto brasileiro para a vigilância unificada de IRAS, almejando segurança e qualidade nos cuidados em saúde.
La formación de los sistemas de vigilancia de infecciones asociadas a la atención en salud (IAAS) es una medida esencial para la planificación de acciones de prevención y control. Algunos modelos importantes en el mundo se están desplegando en las últimas décadas. Este estudio analiza los aspectos históricos y operativos de estos sistemas, discutiendo los desafíos para Brasil. Los modelos internacionales se reflejan en el ejemplo norteamericano, pionero en este proceso. En Brasil varias iniciativas han sido y están siendo establecidas, sin embargo, no se dispone de un pleno sistema nacional de información sobre IAAS, señalando la necesidad de reconocer estrategias vigentes; así como el fortalecimiento del Estado como un enlace de comunicación, buscando un plan nacional para formar equipos de vigilancia con los aparatos tecnológicos necesarios, así como discutiendo la actualización de las leyes que ya no incluyen los desafíos actuales para este tipo de ocurrencias. Estos son pasos esenciales en el contexto brasileño para el control unificado de las IAAS con los objetivos de seguridad y calidad en el cuidado de la salud.