View clinical trials related to Endocarditis.
Filter by:Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage. Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications. Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications. Primary endpoint: 1) Mortality at 1 year Secondary endpoints: 1. Analyze the factors associated with neurological degradation 2. Evaluate the neurological tolerance of cardiac surgery.
Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb is a device designed to remove cytokine (IL-6, IL-10, TNFalpha) from the blood to reduce immune reactions. This trial investigates the use of CytoSorb during cardiac surgery in patients with endocarditis at the University Hospital Basel.
Infective endocarditis is a deadly disease with a mortality rate between 20 and 40%. Antibiotic therapy is of utmost importance. It is primarily guided by microbial results from positive blood culture. However, culture-based microbiological diagnostic can identify the species, but not the strain or the genotypic characteristics of a pathogen. Identifying the strain can be of utmost clinical significance. S. aureus is the most common causative organism of IE worldwide (16%-32%). This pathogen causes massive valve destruction and abscesses, which is strongly dependent on the expression of virulence factors that vary between different S. aureus strains. Functional characterization of S. aureus and determination of virulence factors can currently be achieved through cell culture-based assays (CCBA). However, these tests are very time consuming and cannot be performed as routine clinical diagnostics. Next Generation Sequencing (NSG) has the potential to identify the genotypic characteristics of the pathogen, which is important to determine its virulent potential. The aim of this study is to evaluate the possible utilization of NGS in the prediction of virulence factors of S. aureus and to compare it to the virulence factors determined using CCBA. Hopefully, by comparing the NGS and CCBA, the investigators will get a faster way of determining the possible virulence factors. The NGS method can be further utilized to describe the prevalence of different strains of bacteria in infected valve tissue and blood culture samples. The collected data will serve as a basis for further evaluation of the potentials of NGS-based Diagnosis of IE, as well as a comparison between NGS-guided antibiotic treatment and the standard of care antibiotic treatment.
Background: it is well known that most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which are the first days after diagnosis. Subsequently, the vast majority of patients who overcome this acute phase has a favourable evolution, and usually stay in the hospital for a long time only to complete antibiotic therapy. In stable patients with adequate response to antibiotic treatment, without signs of persistent infection or metastatic foci such as spondylodiscitis, it is likely that a shorter antibiotic regimen would be an efficient and safe alternative, as has already been confirmed in patients with IE on tricuspid valves caused by a microorganism considered virulent such as S. aureus. This attractive alternative would improve patients' quality of life, save costs, and decrease the risk of complications related to the adverse effects of prolonged antibiotic treatment. Objectives: to compare the incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion between patients with IE caused by gram-positive cocci receiving a short-course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy (4-6 weeks). Methodology: multicenter, prospective, randomized, controlled open-label, phase IV clinical trial. Sample: patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients. Intervention: Control group: standard antibiotic therapy, according to ESC guidelines recommendations, for 4 to 6 weeks. Experimental group: short-course antibiotic therapy for 2 weeks. The prevalence of previously known risk factors for adverse events will be compared between the two groups to confirm that randomization have worked properly. The incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.
Current study evaluates the relationship between cell immunity and lipid transport systems in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis) in order to develop new methods for predicting the course and outcome of severe bacterial infections.
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE). Patients will be randomized to receive a single intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the investigators based on the protocol. Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to SoCA to treat S. aureus BSI including IE.
Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI). The aims of our study are: Primary: To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care. Secondary: 1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy. 2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients: A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score". B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve. 3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI. 4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis. 5. To evaluate the rate of 90-day development of Clostridium difficile infection. The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form. All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients. Period of data collection will be from september 2019 to 31th December 2020.
The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s. The main indication for the choice of this prosthesis is a combined pathology with degenerated aortic valve and additional dilatation of the root often involving the ascending aorta. The Freestyle® prosthesis is also used in cases of dissection of the ascending aorta with the involvement of the aortic valve, which opens the debate on how far the ascending aorta should be replaced for a sustainable solution with calculable low periprocedural risk. Considering a lower intraoperative risk in the life-threatening situation, an extended resection of the aorta can be avoided and only the aortic root replaced with a piece of ascending aorta. On the contrary, focusing on improved long-term outcome, the technique of total arch replacement in aortic dissection was developed in emergency situations with acceptable results, which, however, were often reproducible only in large, experienced centers. Apart from the abovementioned options, the technique of proximal arch replacement can provide a tension-free anastomosis. The intention of hemiarch replacement is the attachment of the prosthesis to an aneurysm-free portion of the aortic arch helping to protect against further anastomotic aneurysms and spare the patient complex reoperation or interventional procedures in the future. As a possible drawback of the technique, especially in emergency situations, the potentially prolonged duration of surgery and the need of selective brain perfusion via axillary or carotid artery are discussed increasing the risk of stroke and further major events, which could not be reflected in current literature. However, there is still no convincing evidence of a long-term benefit in terms of re-operation and survival after hemiarch replacement. The aim of this retrospective analysis was to assess the mid-term outcome of the biological Freestyle® prosthesis in combination with operations on the ascending aorta and the aortic arch with regard to prosthetic performance, reoperations, stroke and death.
To evaluate the gender-related elements, a first step will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.
Acute kidney injury (AKI) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery. AKI compromises seriously short and long-term prognosis of critically ill patients. Several AKI risk factors have been identified including a chronic pathology of the patient such as kidney failure or diabetes, acute kidney injury related to hemodynamic disorders during surgery, including cardiopulmonary bypass, or sepsis, and the use of nephrotoxic agents such as some antibiotics, colloids or iodine contrast agents. Avoiding nephrotoxic agents is therefore strongly recommended in ICU patients, to reduce the incidence of AKI, or to reduce its severity. The aim of this cohort study was to assess whether the use of daptomycin, was associated to a lower incidence of AKI than vancomycin in cardiovascular ICU patients, with similar efficacy. This is a retrospective observational study with a propensity score adjustment to reduce the bias of selection for a comparative analysis between two antibacterial treatments used in routine care. Since treatments were not randomized, the investigators used the propensity score method for primary endpoint analysis. For this, the investigators included the covariates potentially related to treatment and outcome in a multivariate logistic model explaining the choice of treatment. This propensity score was used in the second model as an adjustment covariate included in the multivariate analysis to determine factors independently associated with the primary endpoint (AKI within 7 days). The main hypothesis is the first line antibiotic treatment with daptomycin leads to less nephrotoxicity than vancomycin in a population known at high risk for AKI and with at least a similar efficacy on clinical success rate.