Background: Staphylococcus aureus remains a common cause of ventilatorassociated pneumonia, with little change in infection rates over the past 15 years. This phase 2 study evaluated suvratoxumab, an anti-alpha-toxin monoclonal antibody, in reducing incidence of S. aureus pneumonia in intensive care unit (ICU) subjects on mechanical ventilation (MV). Methods:We did a multicenter, single-dose, randomized, placebo-controlled, doubleblind, phase 2 pilot trial in 9 countries. Eligible subjects were patients in an ICU ≥18 years of age, currently intubated and on MV, positive for S. aureus lower respiratory tract (LRT) colonization as assessed by polymerase chain reaction (PCR) of endotracheal aspirate, and with no diagnosis of new-onset pneumonia. Subjects were excluded if they had confirmed or suspected acute ongoing staphylococcal disease; had received anti-S. aureus antibiotics for >48 hours; had a CPIS ≥6, APACHE-II score ≥25, a SOFA score ≥9; or had active pulmonary disease that would impair the ability to diagnose pneumonia. Subjects were screened for S. aureus lower respiratory tract (LRT) colonization using real-time polymerase chain reaction (PCR).Colonized subjects were randomly assigned 1:1:1 to a single intravenous infusion of suvratoxumab 2000 mg, 5000 mg or placebo. Randomization was stratified by country and by whether subjects received anti-S. aureus systemic antibiotic therapy. Based on pre-defined PK criteria, the 2000 mg arm was discontinued upon the recommendation of the data monitoring committee at an interim analysis. Primary efficacy endpoint was incidence of S. aureus pneumonia, adjudicated by a blinded independent panel, through 30 days post dose in the modified intent-to-treat study population. Primary safety endpoints were Francois et al. Suvratoxumab Ph2 (NCT02296320) D3 5 treatment-emergent AEs assessed through 30 and 90 days, treatment-emergent SAEs, adverse events of special interest, and new onset chronic disease, all assessed through 190 days. Findings: PCR screening of 737 ICU subjects identified 213 with S. aureus colonization; of these, 96 were randomized to receive suvratoxumab 5000 mg and 100 to placebo. At 30 days, 17/96 (17•7%) suvratoxumab and 26/100 (26•0%) placebo subjects had developed S. aureus pneumonia (relative risk reduction, 31.9%; 90% confidence interval [CI], −7•5 to 56•8; P = 0•166). At 30 days, incidences of treatmentemergent adverse events (AEs) and serious AEs were similar in suvratoxumab and placebo groups (90•6% [87/96] vs. 90•0% [90/100] and 37•5% [36/96] vs 32•0% [32/100], respectively). At 90 and 190 days, incidence of treatment-emergent AEs was still similar in suvratoxumab and placebo groups (92.
Este estudo tem por objetivo analisar o perfil epidemiológico da COVID-19 em Santa Catarina. Foram estudados os coeficientes de prevalência, incidência, mortalidade e letalidade, com base nos dados secundários fornecidos pela Secretaria de Estado da Saúde de Santa Catarina acerca da distribuição de casos confirmados da COVID-19 no período de 14 semanas (28 de fevereiro a 30 de maio de 2020), e segundo o sexo, a faixa etária e a macrorregião de referência. Os resultados apontam que as taxas de prevalência de casos ativos e incidência em Santa Catarina foram ascendentes, mas de tendência linear, diferentemente da curva exponencial verificada no Brasil, no mesmo período de tempo. Constatou-se uma maior prevalência de casos ativos entre as mulheres, mas um maior número de óbitos e maior taxa de letalidade entre os homens, em praticamente toda a série temporal considerada. As maiores prevalência e incidência da COVID-19 foram detectadas nas faixas entre 20-39 e 40-59 anos, grupos mais sujeitos à exposição e disseminação do vírus, e menor incidência foi detectada na população mais jovem (0-19 anos). A taxa de letalidade por faixa etária mostrou-se especialmente significativa entre os mais idosos. As macrorregiões do Grande Oeste e Foz do Rio Itajaí foram as que mais aportaram casos acumulados da COVID-19, tanto em termos de prevalência quanto de incidência. Novos estudos durante a após a pandemia devem avançar no entendimento da disseminação da doença em Santa Catarina e no Brasil.
Background Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was assessed in PA-colonised mechanically ventilated subjects. Methods EVADE (NCT02696902) was a phase 2, randomised, parallel-group, double-blind, placebo-controlled study in Europe, Turkey, Israel, and the USA. Subjects ≥ 18 years old, mechanically ventilated, tracheally colonised with PA, and without new-onset pneumonia, were randomised (1:1:1) to MEDI3902 500, 1500 mg (single intravenous dose), or placebo. The primary efficacy endpoint was the incidence of nosocomial PA pneumonia through 21 days post-dose in MEDI3902 1500 mg versus placebo, determined by an independent adjudication committee. Results Even if the initial sample size was not reached because of low recruitment, 188 subjects were randomised (MEDI3902 500/1500 mg: n = 16/87; placebo: n = 85) between 13 April 2016 and 17 October 2019. Out of these, 184 were dosed (MEDI3902 500/1500 mg: n = 16/85; placebo: n = 83), comprising the modified intent-to-treat set. Enrolment in the 500 mg arm was discontinued due to pharmacokinetic data demonstrating low MEDI3902 serum concentrations. Subsequently, enrolled subjects were randomised (1:1) to MEDI3902 1500 mg or placebo. PA pneumonia was confirmed in 22.4% (n = 19/85) of MEDI3902 1500 mg recipients and in 18.1% (n = 15/83) of placebo recipients (relative risk reduction [RRR]: − 23.7%; 80% confidence interval [CI] − 83.8%, 16.8%; p = 0.49). At 21 days post-1500 mg dose, the mean (standard deviation) serum MEDI3902 concentration was 9.46 (7.91) μg/mL, with 80.6% (n = 58/72) subjects achieving concentrations > 1.7 μg/mL, a level associated with improved outcome in animal models. Treatment-emergent adverse event incidence was similar between groups. Conclusions The bivalent, bispecific monoclonal antibody MEDI3902 (gremubamab) did not reduce PA nosocomial pneumonia incidence in PA-colonised mechanically ventilated subjects. Trial registration Registered on Clinicaltrials.gov (NCT02696902) on 11th February 2016 and on EudraCT (2015-001706-34) on 7th March 2016.
Introdução: o método Prechtl apresenta-se como um grande aliado na identificação precoce de sequelas neurológicas através da General Movements Assessment – GMA. Objetivo: verificar a associação entre a GMA com os fatores de risco para atraso do desenvolvimento neuropsicomotor (ADNPM). Método: estudo transversal realizado na UTI neonatal, com crianças com menos de 37 semanas, de ambos os sexos, sem distúrbios metabólicos, lesões nervosas periféricas, má formação congênita ou anormalidades cardíacas. Os dados foram coletados através da GMA e associadas com fatores de risco para ADNPM, admitiu-se o nível de significância de 5%. Resultados: 44 prematuros (média de idade 30,9 ± 3,4 semanas; 28 [63,6%] feminino foram analisados. As associações indicaram: prematuridade (OR: 3,42; IC: 0,55-21,17), baixo peso ao nascer (OR: 2,75; IC: 0,44-16,89), hipóxia neonatal (OR: 0,20; IC: 0,03-1,27), hiperbilirrubinemia (OR: 3,84; IC: 0,62-23,85), síndrome do desconforto respiratório (OR: 1,37; IC: 0,24-7,71), sepse (OR: 1,70; IC: 0,15-18,44), fumo (OR: 0,75; IC: 0,07-7,89), uso de álcool (OR: 1,12; IC: 0,11-11,2), infecção urinária (OR: 0,26; IC: 0,04-1,61) e anemia gestacional (OR: 2,03; IC: 0,21-19,49). Conclusão: não houve associação entre os fatores de risco neonatais e obstétrico com os General Movements.
Our aim was to map acquired peripheral and abdominal sarcopenia in mechanically ventilated adults with COVID-19 through ultrasound measurements. On Days 1, 3, 5 and 7 after admission to critical care, the muscle thickness and cross-sectional area of the quadriceps, rectus femoris, vastus intermedius, tibialis anterior, medial and lateral gastrocnemius, deltoid, biceps brachii, rectus abdominis, internal and external oblique, and transversus abdominis were measured using bedside ultrasound. A total of 5460 ultrasound images were analyzed from 30 patients (age: 59.8 ± 15.6 years; 70% men). Muscle thickness loss was found in the bilateral anterior tibial and medial gastrocnemius muscles (range 11.5–14.6%) between Days 1 and 3; in the bilateral quadriceps, rectus femoris, lateral gastrocnemius, deltoid, and biceps brachii (range 16.3–39.1%) between Days 1 and 5; in the internal oblique abdominal (25.9%) between Days 1 and 5; and in the rectus and transversus abdominis (29%) between Days 1 and 7. The cross-sectional area was reduced in the bilateral tibialis anterior and left biceps brachii (range 24.6–25.6%) between Days 1 and 5 and in the bilateral rectus femoris and right biceps brachii (range 22.9–27.7%) between Days 1 and 7. These findings indicate that the peripheral and abdominal muscle loss is progressive during the first week of mechanical ventilation and is significantly higher in the lower limbs, left quadriceps and right rectus femoris muscles in critically ill patients with COVID-19.
Introduction and aim: Studies regarding asynchrony in patients in the cardiac postoperative period are still only a few. The main objective of our study was to compare asynchronies incidence and its index (AI) in 3 different modes of ventilation (volume-controlled ventilation [VCV], pressure-controlled ventilation [PCV] and pressure-support ventilation [PSV]) after ICU admission for postoperative care. Methods: A prospective parallel randomised trial in the setting of a non-profitable hospital in Brazil. The participants were patients scheduled for cardiac surgery. Patients were randomly allocated to VCV or PCV modes of ventilation and later both groups were transitioned to PSV mode. Results: All data were recorded for 5 minutes in each of the three different phases: T1) in assisted breath, T2) initial spontaneous breath and T3) final spontaneous breath, a marking point prior to extubation. Asynchronies were detected and counted by visual inspection method by two independent investigators. Reliability, inter-rater agreement of asynchronies, asynchronies incidence, total and specific asynchrony indexes (AIt and AIspecific) and odds of AI ≥10% weighted by total asynchrony were analysed. A total of 17 patients randomly allocated to the VCV (n= 9) or PCV (n=8) group completed the study. High inter-rated agreement for AIt (ICC 0.978; IC95%, 0,963-0.987) and good reliability (r=0.945; p<0.001) were found. Eighty-two % of patients presented asynchronies, although only 7% of their total breathing cycles were asynchronous. Early cycling and double triggering had the highest rates of asynchrony with no difference between groups. The highest odds of AI ≥10% were observed in VCV regardless the phase: OR 2.79 (1.36-5.73) in T1 vs T2, p=0.005; OR 2.61 (1.27-5.37) in T1 vs T3, p=0.009 and OR 4.99 (2.37-10.37) in T2 vs T3, p<0.001. Conclusions: There was a high incidence of breathing asynchrony in postoperative cardiac patients, especially when initially ventilated in VCV. VCV group had a higher chance of AI ≥10% and this chance remained high in the following PSV phases.
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