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Endocarditis clinical trials

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NCT ID: NCT05547607 Recruiting - Endocarditis Clinical Trials

Clinical and Diagnostic Features of Endocarditis

ENDO-LANDSCAPE
Start date: September 9, 2022
Phase:
Study type: Observational

The burden of endocarditis has changed in the last years due to an increase in percutaneous valve procedures offered to a more fragile, and old population. Therefore an update in epidemiology data is necessary. The Observational prospective multicenter study to characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era, (ENDO-LANDSCAPE study) is an observational, multicenter and international study. The study has two arms: retrospective and prospective. The retrospective arm will involve collecting data from patients discharged with a diagnosis of endocarditis between 2016 and 2022. The data obtained in the retrospective arm of the study will be utilized in a power calculation to determine the sample size for the prospective arm of the study. In the prospective phase in every participating center, all patients referred for echocardiography to assess for endocarditis and those with established endocarditis independent of the screened request will be eligible. Patients will then be stratified according to the presence or abscence of endocarditis. Those with an established diagnosis of endocarditis will be prospectively followed for outcomes.

NCT ID: NCT05530837 Completed - Clinical trials for Infectious Endocarditis

Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome

ENDO_ENTERO
Start date: June 8, 2022
Phase:
Study type: Observational

Infective endocarditis is a complex infection that can be life-threatening. These infections also cause anatomical lesions that can be severe. Their management is complex and involves several disciplines: cardiology, bacteriologists, infectious diseases specialists, radiologists, nuclear medicine specialists, cardiac surgeons, neurologists, pharmacologists, etc. The incidence of Enterococcus faecalis endocarditis is increasing due to the aging of the population and the disappearance of rheumatic fever. The adequate management of these infections is complex and relies on the prolonged administration of high-dose antibiotics, classically the combination of amoxicillin and ceftriaxone. In the context of Streptococcal endocarditis, the impact of increasing the Minimum Inhibitory Concentration (MIC) of amoxicillin on patient mortality has been demonstrated but no study has yet examined the impact of increasing the MIC of amoxicillin on the outcome of patients treated for Enterococcus faecalis infective endocarditis.

NCT ID: NCT05522764 Active, not recruiting - Bacteremia Clinical Trials

Predictors of Infective Endocarditis Among Patients Managed for Staphylococcus Aureus Bacteremia, Particularly Staphylococcus Aureus Bacteriuria, and Time to Blood Culture Positivity

BACT_URIE
Start date: July 18, 2022
Phase:
Study type: Observational

Staphylococcus aureus is a frequent cause of primary or secondary bacteremia. It is also responsible for many cases of infective endocarditis, for which the therapeutic management is specific. The frequency of infective endocarditis among Staphylococcus aureus bacteremias varies between 2.7% and 23.4%. Many factors associated with the risk of developing endocarditis in patients with S. aureus bacteremia have been described. Two parameters of potential interest remain excluded from this work: blood culture growth time, a marker of bacterial inoculum, and the presence of bacteriuria, which is common during bacteremia. The objective of this study is to evaluate the interest of these two parameters in the prediction of the presence of endocarditis during S. aureus bacteremia. Investigators will conduct a retrospective study including all patients managed for Staphylococcus aureus bacteremia and in whom a urine culture was performed. The primary objective is to describe the factors associated with the occurrence of endocarditis in patients managed for S. aureus bacteremia and who received a urine cytobacteriological examination (UCE). The secondary objectives are: to evaluate the factors associated with the occurrence of S. aureus bacteriuria in patients with S. aureus bacteremia and to evaluate the risk factors for mortality in patients managed for S. aureus bacteremia.

NCT ID: NCT05474118 Completed - Infectious Disease Clinical Trials

Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M

CEFASTA
Start date: February 5, 2020
Phase:
Study type: Observational

Retrospective, regional, multicenter study (including the Annecy-Genevois Hospital Center, the Chambéry Métropole Savoie Hospital Center, and the Grenoble University Hospital Center), comparing a cohort of patients treated with Cefazolin with a cohort of patients treated with Penicillin M

NCT ID: NCT05455788 Recruiting - Clinical trials for Prosthetic Valve Endocarditis

Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?

Start date: December 1, 2021
Phase:
Study type: Observational

Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.

NCT ID: NCT05446376 Not yet recruiting - Clinical trials for Infective Endocarditis

Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis

CiGal-EI-TEP
Start date: February 2024
Phase: Phase 2
Study type: Interventional

CiGal-EI-TEP is an exploratory study that aim to assess the diagnostic performance of 68Ga Positron emission tomography (PET) / Computed Tomography (CT) for the diagnosis of prosthetic valve infective endocarditis in comparison with the final diagnosis established according to the ESC 2023 criteria, after 3 months of follow-up, by a panel of experts.

NCT ID: NCT05432427 Recruiting - Endocarditis Clinical Trials

64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis.

Start date: April 28, 2022
Phase: N/A
Study type: Interventional

The investigators hypothesize that the 64Cu-DOTATATE will show uptake in the infected vegetations on the prosthetic heart valves and increase the accuracy of the right diagnosis - thus increasing the sensitivity and specificity compared to 18F-FDG PET/CT

NCT ID: NCT05398679 Not yet recruiting - Clinical trials for Endocarditis Infective

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

OraPAT-IEGAMES
Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis

NCT ID: NCT05398289 Not yet recruiting - Clinical trials for Enterococcal Endocarditis

FOUR-SIX TRIAL for the Treatment of Enterococcal Endocarditis

FOURSIX
Start date: January 1, 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05378126 Recruiting - Stroke Clinical Trials

Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated With Cerebral MRI in the Acute Phase of Infectious Endocarditis

POMPEI
Start date: April 6, 2023
Phase: N/A
Study type: Interventional

Infectious endocarditis (IE) is a serious condition with an annual incidence of 3 to 10 per 100,000 people. Brain infarctions complicate approximately 20-40% of endocarditis. Brain MRI can detect the presence of recent ischemic lesions and asymptomatic microbleeds. Preoperative brain imaging is part of the recommended assessment in the management of IEs, but the type of imaging and sequences are not codified and the impact of cerebral and vascular imaging findings on the therapeutic decision remains uncertain. The level of evidence of the recommendations remains low, especially for complicated IEs of stroke. There is very little neurological clinical data on patients with IEs. Similarly, neurologists do not systematically participate in multidisciplinary meetings during the management of an IE. It therefore seems interesting to carry out a neurological cohort of this population and to evaluate what would be the contribution of vascular neurologists in the management of infectious endocarditis.