RESUMO
We investigated the performance of the Xpert methicillin-resistant Staphylococcus aureus (MRSA)/S. aureus skin and soft tissue (SSTI) quantitative PCR (qPCR) assay in SAATELLITE, a multicenter, double-blind, phase 2 study of suvratoxumab, a monoclonal antibody (MAb) targeting S. aureus alpha-toxin, for reducing the incidence of S. aureus pneumonia. The assay was used to detect methicillin-susceptible S. aureus (MSSA) and MRSA in lower respiratory tract (LRT) samples from mechanically ventilated patients. LRT culture results were compared with S. aureus protein A (spa) gene cycle threshold (CT) values. Receiver operating characteristic (ROC) and Youden index were used to determine the CT cutoff for best separation of culture-S. aureus-negative and S. aureus-positive patients. Of 720 screened subjects, 299 (41.5%) were S. aureus positive by qPCR, of whom 209 had culture data: 162 (77.5%) were S. aureus positive and 47 (22.5%) were S. aureus negative. Culture results were negatively affected by antibiotic use and cross-laboratory variability. An inverse linear correlation was observed between CT values and quantitative S. aureus culture results. A spa CT value of 29 (≈2 × 103 CFU/mL) served as the best cutoff for separation between culture-negative and culture-positive samples. The associated area under the ROC curve was 83.8% (95% confidence interval [CI], 78 to 90%). Suvratoxumab provided greater reduction in S. aureus pneumonia or death than placebo in subjects with low S. aureus load (CT ≥ 29; relative risk reduction [RRR], 50.0%; 90% CI, 2.7 to 74.4%) versus the total study population (RRR, 25.2%; 90% CI, -4.3 to 46.4%). The qPCR assay was easy to perform, sensitive, and standardized and provided better sensitivity than conventional culture for S. aureus detection. Quantitative PCR CT output correlated with suvratoxumab efficacy in reducing S. aureus pneumonia incidence or death in S. aureus-colonized, mechanically ventilated patients.
Assuntos
Staphylococcus aureus Resistente à Meticilina , Infecções dos Tecidos Moles , Infecções Estafilocócicas , Humanos , Staphylococcus aureus Resistente à Meticilina/genética , Reação em Cadeia da Polimerase em Tempo Real , Respiração Artificial/efeitos adversos , Infecções Estafilocócicas/diagnóstico , Infecções Estafilocócicas/tratamento farmacológico , Staphylococcus aureus/genéticaRESUMO
Ante la situación excepcional de salud pública provocada por la pandemia por COVID-19, desde el grupo de ética de la Sociedad Española de la Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC) se ha promovido un trabajo de consenso, con el objetivo de encontrar algunas respuestas desde la ética a la encrucijada entre el incremento de personas con necesidades de atención intensiva y la disponibilidad efectiva de medios. En un periodo muy corto de tiempo, se ha cambiado el marco de ejercicio de la medicina hacia un escenario de "medicina de catástrofe", con el consecuente cambio en los parámetros de toma de decisiones. En este contexto la asignación de recursos o la priorización de tratamiento pasan a ser elementos cruciales, y es importante contar con un marco de referencia ético para poder tomar las decisiones clínicas necesarias. Para ello, se ha realizado un proceso de revisión narrativa de la evidencia, seguida de u. consenso de expertos no sistematizado, que ha tenido como resultado tanto la publicación de un documento de posicionamiento y recomendaciones de la propia SEMICYUC, como el consenso entre 18 sociedades científicas y 5 institutos/cátedras de bioética y cuidados paliativos de un documento marco de referencia de recomendaciones éticas generales en este contexto de crisis
In view of the exceptional public health situation caused by the COVID-19 pandemic, a consensus work has been promoted from the ethics group of the Spanish Society of the Spanish Society of Intensive, Critical Medicine and Coronary Units (SEMICYUC), with the objective of finding some answers from ethics to the crossroads between the increase of people with intensive care needs and the effective availability of means. In a very short period, the medical practice framework has been changed to a "catastrophe medicine" scenario, with the consequent change in the decision-making parameters. In this context, the allocation ofresources or the prioritization of treatment become crucial elements, and it is important to have an ethical reference framework to be able to make the necessary clinical decisions.For this, a process of narrative review of the evidence has been carried out, followed by u. Unsystematic consensus of experts, which has resulted in both the publication of a position paper and recommendations from SEMICYUC itself, and the consensus between 18 scientific societies and 5 institutes / chairs of bioethics and palliative care of a framework document of reference for general ethical recommendations in this context of crisis
Assuntos
Humanos , Consenso , Tomada de Decisões/ética , Unidades de Terapia Intensiva/ética , Infecções por Coronavirus/diagnóstico , Revisão por Pares , Pandemias/ética , Sociedades Médicas/ética , Sociedades Médicas/normasAssuntos
Neurofibromatoses/diagnóstico , Face , Feminino , Humanos , Pessoa de Meia-Idade , Neurofibromatoses/patologiaRESUMO
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