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Infective Endocarditis clinical trials

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NCT ID: NCT03199287 Completed - Clinical trials for Infective Endocarditis

Clinical Metagenomics of Infective Endocarditis

Meta-ENDO
Start date: June 8, 2017
Phase:
Study type: Observational

Infective endocarditis (IE) is an infection of cardiac valves. IE mainly involves bacteria, more rarely fungi. IE is an uncommon diseases with an estimated incidence of 1-12 cases per 100,000 inhabitants per year. The diagnostic of IE relies on the culture of biological samples (blood cultures and per-operative samples) in the bacteriology laboratory in order to identify the pathogen and its susceptibility to antimicrobials. Nonetheless in about 10% of the cases, the blood cultures remain negative, due to antibiotics taken before harvesting, to non-culturable bacteria or to aseptic phenomena. Clinical metagenomics is defined as the application of high-throughput sequencing (NGS) followed by a specific bioinformatics analysis to obtain clinical information, i.e. pathogen identification and the prediction of their susceptibility to antimicrobials. The metagenome of a sample (i.e. all the genomes of the organisms present) virtually contains all the information necessary for bacteriological diagnosis: what is the pathogenic bacteria , and to which antibiotics it is susceptible. Hence, using clinical metagenomics in the context of IE appears seducing in order to overcome the limitations of conventional methods based on culture. Here, we propose to assess the performance of clinical metagenomics in the diagnostic of IE.

NCT ID: NCT03153384 Completed - Bacteremia Clinical Trials

Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis

UniEndo
Start date: November 11, 2017
Phase:
Study type: Observational [Patient Registry]

To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis.

NCT ID: NCT02940340 Completed - Clinical trials for Infective Endocarditis

Evaluation of Systemic Microvascular Endothelial Dysfunction in Patients Presenting With Infective Endocarditis

Start date: January 2016
Phase: N/A
Study type: Observational

Infective endocarditis (IE) is a severe clinical condition with a high in-hospital and 5-year mortality. It has a growing incidence, both related to healthcare and possibly to changes in prophylaxis recommendations regarding oral procedures. Though not a new disease, several aspects in its clinical and laboratory diagnosis remain to be better studied and innovated. The evaluation of systemic microvascular disease has proven crucial in the investigation and comprehension of pathophysiology of cardiovascular diseases, as well as a tool for early diagnosis and prediction of complications. Few studies deal with microcirculation in patients with IE, and so far none utilizing speckle contrast imaging and functional capillary density. The present study will contribute to the investigation of microcirculatory changes in IE and possibly to earlier diagnosis of the condition and/or of its severity and complications. The aim of the study is to evaluate the changes in microvascular bed of patients with both acute and subacute endocarditis by speckle contrast imaging and skin video-capillaroscopy.

NCT ID: NCT02910856 Completed - Clinical trials for Infective Endocarditis

Infective Endocarditis in the Elderly

ELDERL-IE
Start date: March 2015
Phase:
Study type: Observational

ELDERL-IE is a multicenter national prospective observational study. The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE). The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

NCT ID: NCT02887079 Completed - Clinical trials for Infective Endocarditis

Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis

EMBOL-EI
Start date: January 1, 2014
Phase:
Study type: Observational

EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in infective endocarditis) is a prospective cohort study with a biological collection. The main objective is: to re-evaluate the potential value of antiphospholipid (aPL) antibodies as predictors of embolic events in infective endocarditis (IE) in the light of the improved current knowledge on these aPL. The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von Willebrand factor) will be taken into account in the analysis, and interest in predicting embolic risk, alone or in combination with aPL will be investigated.

NCT ID: NCT02727413 Completed - Clinical trials for Valvular Heart Disease

Inflammatory Mediator Profiles During Heart Valve Replacement Surgery

Remove-Pilot
Start date: June 2016
Phase:
Study type: Observational

The study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative valvular heart disease. Specific attention will focus on the distinction between mediator release associated with infection and that resulting from CPB. Concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.

NCT ID: NCT02701608 Recruiting - Clinical trials for Infective Endocarditis

Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus

Start date: February 29, 2016
Phase: Phase 3
Study type: Interventional

Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations. A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery. These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort. There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's. The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE. Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction. It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for multisusceptible staphylococci with a benefit regarding costs. The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

NCT ID: NCT02701595 Recruiting - Clinical trials for Infective Endocarditis

Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus

Start date: February 29, 2016
Phase: Phase 3
Study type: Interventional

Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations. A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery. These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort. There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's. The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE. Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as amoxicillin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction. It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for streptococci, and enterococci IE with a benefit regarding costs. The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

NCT ID: NCT02698930 Recruiting - Clinical trials for Infective Endocarditis

Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

Start date: August 2016
Phase: N/A
Study type: Interventional

Acute kidney injury is major complication after open heart surgery. The cause of acute kidney injury following open heart surgery is related to activation of sympathetic nervous system, decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory response. Infective endocarditis patients undergoing open heart surgery have systemic inflammatory response associated with infective endocarditis. And the inflammatory response can be aggravated by cardiopulmonary bypass. The incidence of acute kidney injury following open heart surgery due to infective endocarditis was 50% in a previous report. And this acute kidney injury was related to the poor outcome and high mortality. Thus, the preventive method to protect kidney function will be needed in the patients with infective endocarditis undergoing open heart surgery. Dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and CNS depressive effect. And several experimental study demonstrated the renal protective effect. Intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed and suppress the sympathetic response resulted by surgical stimulation. And dexmedetomidine was reported to reduce the level of serum cortisol, epinephrine and norepinephrine during the operation. Thus, these effects of dexmedetomidine can be expected to reduce the incidence of acute kidney injury. Therefore, the investigators hypothesized that dexmedetomidine has renal protective effect and this effect might be related to the suppression of inflammatory response. Thus, the investigators will evaluate the incidence of acute kidney injury and the incidence of major adverse kidney events (MAKE) after open heart surgery due to infective endocarditis and the level of inflammatory mediators. The primary end point of this study is the incidence of acute kidney injury after open heart surgery due to infective endocarditis. And secondary end point is the incidence of MAKE, the level of cystatin C which is related to the renal function, the level of inflammatory mediator and the postoperative morbidities.

NCT ID: NCT02466139 Completed - Clinical trials for Infective Endocarditis

Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes in Infective Endocaridtis

CRP-IE
Start date: April 2012
Phase: N/A
Study type: Observational [Patient Registry]

The investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. The investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality.