View clinical trials related to Endocarditis.
Filter by:Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Duration of therapy in severe infections has a high impact in term of compliance, adverse events, and costs but also in term of antibiotic pressure on selection of multidrug-resistant pathogens. In this context, many advancements have been obtained for an early diagnosis of IE with a strict selection of criteria for surgery. Moreover, the use in antibiotic regimen of new drugs with peculiar PK/PD characteristics, as a quick bactericidal action, also for IE was not accompanied to a revaluation of duration of antibiotic treatment. On this basis, US and European guidelines recommend a 6-week duration of antibiotic treatment for IE due to enterococcal species. AIM 1: To evaluate a 4-week duration of antibiotic therapy versus a 6-week duration according to international guidelines. AIM 2: Second aim is to evaluate the PK/PD of antimicrobials in relation to the probability of target attainment (PTA) of optimal exposure against enterococci. AIM 3: Finally, we will analyze the bactericidal activities of antibiotic combinations used in patients with IE and the survival of the subgroup of patients who underwent surgery. Open-label, multicenter, randomized, non-inferiority trial to be conducted in a 3-year period. The institutional review board at each site will approve the protocol, and all patients or their authorized representatives will provide written informed consent. Eligible patients will be 18 years of age or older with a documented IE due to enterococcal strains, according to the modified Duke criteria. 63 patients in each of the two arms. The study will be conducted at Italian sites. Data on demographic characteristics, comorbidities, antibiotic and concomitant therapies will be collected. Baseline treatments will be defined according to the patients' pharmacological history. IE will be defined according to modified Duke criteria. Antibiotic treatment, indications and timing of surgery will be based on the 2015 American Heart Association and European Society of Cardiology guidelines. Blood samples for determining antibiotic concentrations of ampicillin, gentamicin, vancomycin, daptomycin and linezolid will be collected at predetermined times in order to allow estimation of PK/PD. Randomization: 1. 4-week duration of antibiotic therapy 2. standard 6-week duration of antibiotic therapy The intention-to-treat population (ITT) will include all randomized patients. The modified intention-to-treat population (mITT) will include all randomized patients receiving at least one dose of study medication. The clinically evaluable (CE) population will include ITT patients demonstrating sufficient adherence to study protocol. Primary endpoint: non-inferiority of a 4-week course in terms of outcome at 60 days. Secondary endpoints: microbiological eradication, pharmacological concentrations of antibiotic regimens, patients undergoing surgery, duration of therapy according with resistance profile of enterococcal species.
Study hypothesis: 68Ga-DOTATOC PET/CT could detect cardiac foci of infective endocarditis regardless of the type of valve (native or prosthetic) and also extracardiac localizations related to this pathology (infection responsible, peripheral emboli, ...). This study is a proof of concept with low population
The main objective of this study is to better estimate the rate of infectious intracranial aneurysms (IIA) in proved infective endocarditis (IE). It also aims to identify MRI markers capable of accurately predicting (or excluding) IIA; to assess the impact of the different MRI abnormalities on the outcome; to capture the real-world management of EI with neurological complications in comprehensive IE centers in France
This study aims to achieve the following objectives - objective 1 : To review the Investigators' experience of surgical management of infective endocarditis (IE) and analyze the outcomes and associated prognostic factors - objective 2 : To provides information on early and late clinical outcomes of patients undergoing surgery for IE - objective 3 : To evaluate the impact of perioperative clinical variables and identification of perioperative prognostic factors - objective 4 : To determine the indications of surgical intervention and the best time of the surgery
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.
Infective endocarditis is a microbial infection of the endocardial surface of the heart.
Indocarditis is an endogenous infection acquired when organisms entering the blood stream establish on the heart valves, therefore, any bacteremia can potentially result in endocarditis. Infective endocarditis is an uncommon disease that often presents as pyrexia of unknown origin. The mortality rate in endocarditis was very high before the antibiotic era, even now a day, the mortality rate is around 20%(1).A variety of microorganisms can cause IE; staphylococci and streptococci account for the majority of cases. Staphylococcal IE is a common cause of healthcare-associated IE ; streptococcal IE is a common cause of community-acquired IE. Common bacterial pathogens include Staphylococcus aureus , Viridans group streptococci , Enterococcus, Coagulase-negative staphylococci , Streptococcus bovis , other streptococci , gram-negative bacteria, HACEK organisms in this category include a number of fastidious gram-negative bacilli: Haemophilus aphrophilus(subsequently called Aggregatibacter aphrophilus and Aggregatibacter paraphrophilus); Actinobacillus actinomycetemcomitans (subsequently called Aggregatibacter actinomycetemcomitans); Cardiobacterium hominis; Eikenella corrodens; and Kingella kingae , and fungi (1,2). A variable proportion of IE remain blood culture- negative (1-4). Most clinically significant bacteremias are detected within 48 hours; common and fastidious pathogens (such as members of the HACEK group) may be detected within five days of incubation with modern automated blood culture detection systems. The optimal volume of blood for each blood culture in adults is 20 ml. Zoonotic agents, such as Coxiella burnetii, Brucella spp., and Bartonella spp. were frequently detected in North Africa and identified as causes of infective endocarditis (IE) in Egypt (3,4).Blood culture is the most important investigation for diagnosing infective endocarditis andto know the prevalence rate of different bacteria and their antibiotic sensitivity pattern.Positive blood culture is the cornerstone of microbiological diagnosis of IE; three sets of blood cultures detect 96 to 98 percent of bacteremia. At least three sets of blood cultures should be obtained from separate venipuncture sites prior to initiation of antibiotic therapy. Patients with IE typically have continuous bacteremia; therefore, blood cultures may be collected at any time and need not necessarily be obtained at the time of fever or chills. MATERIAL and METHOD A total of 150 blood cultures were received from 50 clinically diagnosed cases of bacterial endocarditis . Blood sample was collected under all aseptic precautions.
Introduction. Comprehensive data on infective endocarditis in developing countries are scarce. Objectives: Description of the characteristics (clinical and microbiological) and assessment of the outcomes of infective endocarditis in low-income countries. Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged over 1 year fulfilling the modified Duke criteria for infective endocarditis. Exclusion criteria: patient included during a previous infective endocarditis episode. Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access to antibiotic treatment (modalities and duration), hospital length of stay and reason for discharge, and cardiac surgery when indicated. Duration: One year (June 2014- June 2015)
Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale clinical trials conducted that included more than 1,000 subjects and than Daptomycin got complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood flow and endocardial infected patients. All subjects in Daptomycin clinical trials are European and American race. It is necessary that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to evaluate the safety and efficacy of Daptomycin which were used in patients with serious gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin future using.