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Endocarditis, Bacterial clinical trials

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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: NCT05264181 Recruiting - Clinical trials for Congenital Heart Disease

Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve

EUROPULMS3
Start date: September 1, 2021
Phase:
Study type: Observational

Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right ventricular outflow tract dysfunction in patients with congenital heart diseases. Long-term outcomes following this procedure using the new generation SAPIEN 3 valve is little known. Purpose This study aims to report mid-term outcomes in a large cohort of patients who had TPVI using the SAPIEN 3 valve. Methods We designed a retrospective multicentre observational registry of patients undergoing TPVI with the SAPIEN 3 valve across centres in Europe, Middle-east and Canada. Patient-related, procedural, and mid-term outcomes data will be characterized.

NCT ID: NCT05061355 Recruiting - Clinical trials for Endocarditis Infective

Antibiotics vs Antibiotics and Surgical ThERapy for Infective Endocarditis

ASTERIx
Start date: September 9, 2021
Phase: N/A
Study type: Interventional

Infective endocarditis (IE) is a deadly disease and the incidence is increasing. An important initial assessment of patients with IE includes whether surgical treatment is indicated; yet, appropriate data to guide this assessment do not exist. The ASTERIx study will assess whether a surgical approach in addition to medical care for treatment of IE is superior to medical care alone. In total, 496 patients will be included in the study over four years. The study is event-driven and will require at least 240 events. The study will assess the primary composite outcome of death, embolization, relapse of IE, new heart failure or reinfection. Study participants who survive to discharge will be followed by routine clinical check-ups at one- and four-weeks post-discharge and at three months. Additionally a 12-month study follow-up is planned. The investigators will also conduct a small substudy to assess the frequency of silent emboli.

NCT ID: NCT04992923 Recruiting - Clinical trials for Infective Endocarditis

Prospective Cohort Study of Patients With Infective Endocarditis at Pitié-Salpêtrière Hospital

EIPSL
Start date: September 15, 2020
Phase:
Study type: Observational [Patient Registry]

Infective endocarditis (IE) is a severe condition associated with high mortality. Due to the relative low prevalence of IE, prospective data are lacking and current guidelines are mostly based on expert consensus with low level of evidence. IE is also associated with severe complications especially strokes that occur in about one third of the patients. In order to improve the management and the prognosis of IE, clinical data from larges prospective cohort studies are needed.

NCT ID: NCT04840225 Recruiting - Anemia Clinical Trials

Anemia in Patients With Endocarditis

ANIE
Start date: March 22, 2021
Phase:
Study type: Observational

Prospective study of prevalence and deep charecterization of anemia in patients with endocarditis from diagnosis undtill 6 months after discharge.

NCT ID: NCT04792281 Recruiting - Clinical trials for Infective Endocarditis

Impact of FDG-PET/CT on Management of Patients With Native Valve Infective Endocarditis

PET-NAVIE
Start date: August 31, 2021
Phase:
Study type: Observational

The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.

NCT ID: NCT04647331 Recruiting - Clinical trials for Infective Endocarditis

Betalactam Pharmacokinetics in Endocarditis Patients

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

Infectious endocarditis (IE) is associated with mortality rates of 10-12%. Adequate antibiotic therapy is crucial for survival and is administered in high doses due to the severity of the disease. In most cases, beta-lactam antibiotics (e.g. ampicillin, penicillin G, cefotaxime or cloxacillin) are employed. A number of patient characteristics, such as age, body weight, and renal function) influence the pharmacokinetics of these drugs. Yet, the interindividual variability is poorly understood meaning that a large proportion of patients are at risk of subtherapeutic or excessive drug concentrations that might result in treatment failure or side effects, respectively. In the present study, data will be collected on antibiotic concentrations in patients treated with beta-lactams for infectious endocarditis as well as patient characteristics and treatment outcomes. A mathematical model will be developed to determine which patient factors determine drug pharmacokinetics. Based on this model, predictions will be made by mathematical simulations on which dosing regimens are optimal for individual patients to ensure therapeutic and non-toxic drug concentrations. In total, 150 patients will be included at four University Hospitals in Sweden; Uppsala University Hospital, Sahlgrenska University Hospital in Gothenburg, Skåne University Hospital in Lund and Karolinska University Hospital in Stockholm. Following informed consent to participate blood samples will be collected at 6 time-points during a dose interval and then at 3 time-points weekly during the full treatment episode (maximum 6 weeks).

NCT ID: NCT04544306 Recruiting - Clinical trials for Infective Endocarditis

Partial Oral Antimicrobials to Treat Infective Endocarditis in People Who Inject Drugs

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Infective endocarditis (IE) is a serious infection associated with significant morbidity and mortality. Recent studies demonstrated an increased risk of infective endocarditis in people who inject drugs (PWIDs). PWIDs have a high rate of non-compliance with hospital admissions and leaving against medical advice. A recent landmark randomized controlled trial demonstrated similar outcomes when comparing partial oral antimicrobial therapy to continued intravenous antimicrobial therapy in the general population. Performing a trial to explore the non-inferiority of oral compared to intravenous antimicrobial therapy in PWIDs is essential in advancing patient care in this high risk increasing population.

NCT ID: NCT04257292 Recruiting - Clinical trials for Infective Endocarditis

NExt-Generation Sequencing and Cell Culture-based Characterization of S. Aureus in Infective Endocarditis

NESSIE
Start date: September 1, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT03892174 Recruiting - Sepsis Clinical Trials

Cytokine REmoval in CRitically Ill pAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)

RECREATE
Start date: November 14, 2019
Phase: N/A
Study type: Interventional

Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.