In a recent study of our group with the acronym ACTIVATE, Bacillus Calmete-Guérin (BCG) vaccination reduced the occurrence of new infections compared to placebo vaccination in the elderly. Most benefit was found for respiratory infections. The ACTIVATE-2 study was launched to assess the efficacy of BCG vaccination against coronavirus disease 2019 (COVID-19). In this multicenter, double-blind trial, 301 volunteers aged 50 years or older were randomized (1:1) to be vaccinated with BCG or placebo. The trial end points were the incidence of COVID-19 and the presence of anti–severe acute respiratory syndrome coronavirus 2 (anti–SARS-CoV-2) antibodies, which were both evaluated through 6 months after study intervention. Results revealed 68% relative reduction of the risk to develop COVID-19, using clinical criteria or/and laboratory diagnosis, in the group of BCG vaccine recipients compared with placebo-vaccinated controls, during a 6-month follow-up (OR 0.32, 95% CI 0.13-0.79). In total, eight patients were in need of hospitalization for COVID-19: six in the placebo group and two in the BCG group. Three months after study intervention, positive anti–SARS-CoV-2 antibodies were noted in 1.3% of volunteers in the placebo group and in 4.7% of participants in BCG-vaccinated group. These data indicate that BCG vaccination confers some protection against possible COVID-19 among patients older than 50 years with comorbidities. BCG vaccination may be a promising approach against the COVID-19 pandemic.
CKD is associated with worse cardiac autonomic function. Haemodialysis therapy for 3 months improves some indices of HRV, and this effect is more pronounced in non-diabetic subjects. Our findings suggest that the improvement of HRV after the initiation of chronic dialysis therapy can ameliorate clinical outcomes and survival in patients with end-stage renal disease.
BackgroundDevelopment of sepsis is a process with significant variation among individuals. The precise elements of this variation need to be defined. This study was designed to define the way in which comorbidities contribute to sepsis development.MethodsThree thousand five hundred nine patients with acute pyelonephritis (AP), community-acquired pneumonia (CAP), intraabdominal infections (IAI) or primary bacteremia (BSI) and at least two signs of the systemic inflammatory response syndrome were analyzed. The study primary endpoint was to define how comorbidities as expressed in the Charlson’s comorbidity index (CCI) and the underlying type of infection contribute to development of organ dysfunction. The precise comorbidities that mediate sepsis development and risk for death among 18 comorbidities recorded were the secondary study endpoints.ResultsCCI more than 2 had an odds ratio of 5.67 for sepsis progression in patients with IAI between significantly higher than AP and BSI. Forward logistic regression analysis indicated seven comorbidities that determine transition into sepsis in patients with AP, four comorbidities in CAP, six comorbidities in IAI and one in BSI. The odds ratio both for progression to sepsis and death with one comorbidity or with two and more comorbidities was greater than in the absence of comorbidities.ConclusionsThe study described how different kinds of infection vary in the degree to which they lead to sepsis. The number of comorbidities that enhances the risk of sepsis and death varies depending on the underlying infections.Electronic supplementary materialThe online version of this article (10.1186/s12879-018-3156-z) contains supplementary material, which is available to authorized users.
BCG vaccination induces heterologous protection against respiratory tract infections, and in children improves survival independently of tuberculosis prevention. The phase III ACTIVATE-2 study assessed whether BCG could also protect against COVID19 in the elderly. In this double-blind, randomized trial, elderly Greek patients were randomized (1:1) to receive either BCG revaccination or placebo at hospital discharge, followed by 6 months observation for incidence of COVID19 infection. BCG revaccination resulted in 68% risk reduction for total COVID19 clinical and microbiological diagnoses (OR 0.32, 95% CI 0.13-0.79). Five patients in the placebo group and one in the BCG-vaccinated group had severe COVID19 that necessitated hospitalization. 3 months after BCG vaccination 1.3% of placebo and 4.7% of BCG-vaccinated volunteers had anti-SARS-CoV-2 antibodies. These data argue that BCG revaccination is safe and protects the elderly against COVID19. BCG revaccination may represent a viable preventive measure against COVID19.
Purpose:To measure the apparent diffusion coefficient (ADC) after inhalation of hyperpolarized 3 He in healthy volunteers and lung transplant recipients, and demonstrate the gravity dependence of ADC values. Materials and Methods:Six healthy volunteers, 10 patients after single-lung transplantation, and six patients after double-lung transplantation were examined at 1.5T during inspiration and expiration. The inhalation of 300 mL of hyperpolarized 3 He was performed with a computer-controlled delivery device. A two-dimensional fast low-angle shot (FLASH) sequence measured the 3 He diffusive gas movement. From these data the ADC was calculated. Results:The mean ADC was 0.143 cm 2 /second in healthy individuals, 0.162 cm 2 /second in transplanted healthy lungs, and 0.173 cm 2 /second in rejected transplanted lungs, whereas it was 0.216 cm 2 /second in native fibrotic lungs and 0.239 cm 2 /second in emphysematous lungs. The difference in mean ADC values among healthy lungs, healthy transplanted lungs, and native diseased lungs was significant (P Ͻ 0.001). In inspiration the healthy volunteers showed higher ADC values in the anterior than in the posterior parts of the lungs. In expiration this gradient doubled. Conclusion:An anterior-posterior (A/P) gradient was found in inspiration and expiration in healthy lungs. Healthy, transplanted, and native diseased lungs had significantly different mean ADC values. From our preliminary results, 3 He MRI appears to be sensitive for detecting areas of abnormal ventilation in transplanted lungs.
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