Endocarditis

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index (MDPI) to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass (CPB). This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts: first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions; second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables; and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

Researchers are evaluating a shorter antibiotic treatment for patients with left-sided infectious endocarditis caused by Streptococci, Enterococcus faecalis, or Staphylococcus aureus. The study aims to assess whether reducing the treatment duration, based on individual patient response and clinical data, is as safe and effective as the standard longer treatment. This approach may reduce hospital stays and related risks such as mental strain and loss of function. Participants are randomly assigned to receive either accelerated antibiotic treatment or the standard length of treatment. The accelerated group receives shorter treatment durations tailored to the type of bacteria and disease complexity, ranging from 2 to 4 weeks, with adjustments after cardiac surgery. The standard group follows usual treatment durations of 4 to 6 weeks depending on bacterial type and disease status. This open-label study includes approximately 475 patients. During the study, researchers monitor safety outcomes such as mortality, embolic events, and unplanned heart surgery up to 6 months after randomization. They also assess efficacy by measuring days alive without antibiotic treatment and track secondary outcomes including hospital stay length, treatment costs, catheter complications, and recurrence of infection. Participants undergo regular clinical evaluations, laboratory tests, and follow-up visits to collect these data throughout the study period.

Researchers are evaluating treatment options for patients with probable or definite prosthetic valve endocarditis caused by Staphylococcus aureus. The study aims to determine whether not giving rifampin, an antibiotic, is no worse than giving rifampin alongside standard care. This is a Phase 3 randomized clinical trial led by Todd C. Lee MD MPH FIDSA. Participants will be randomly assigned to one of two groups: one will receive adjunctive rifampin at a dose of 900 mg per day divided into 2-3 doses, while the other group will not receive rifampin. The study will follow participants for outcomes related to treatment success or failure, including monitoring for adverse reactions and other complications. During the trial, participants will be monitored for treatment failure over 180 days, including deaths, unplanned cardiac surgery, new embolic events, and relapse of bacteremia. Additional assessments within 56 days will track discontinuation of rifampin due to drug interactions or adverse reactions. Participants will be followed closely to evaluate safety and effectiveness throughout the study period, which extends up to 180 days after treatment begins.

Researchers are establishing the Barts Endocarditis Research Registry to study Infective Endocarditis (IE) in their patient population. The registry aims to assess the characteristics of IE, the use of imaging techniques, and how European Society of Cardiology (ESC) guidelines affect patient prognosis. This research will improve diagnosis and management, forming the foundation for future studies, including interventional trials to evaluate treatments and outcomes. The registry collects detailed information on epidemiology, demographics, microbiology, surgery, and patient outcomes. It tracks patients admitted with IE, those attending outpatient clinics, and patients with cardiac device-related infections. The multidisciplinary team discusses cases weekly to ensure consistent, evidence-based care. Data collection spans up to 10 years, supporting the evaluation of mortality, morbidity, reinfection, and relapse rates. Participants provide informed consent and are monitored through regular data collection on their infection status, treatments, and outcomes. Researchers review imaging findings, infectious organisms, and pathological markers to better understand their relationship to patient health. This long-term registry supports ongoing safety reviews and helps shape future research to improve care for IE patients.

Researchers are studying infectious endocarditis (IE), a serious heart infection with a 10-12% mortality rate, to better understand how beta-lactam antibiotics behave in the body. These antibiotics, including ampicillin, penicillin G, cefotaxime, and cloxacillin, are given in high doses, but patient factors like age, weight, and kidney function affect how the drugs are processed, which may impact treatment success or side effects. The study collects detailed data from 150 patients treated with these antibiotics at four university hospitals in Sweden. Blood samples are taken frequently during the treatment period, including six samples within one dosing interval and additional samples weekly for up to six weeks. Patient information such as age, weight, gender, and routine biomarker results are also recorded. The goal is to develop a mathematical model predicting optimal dosing for individual patients. Participants provide informed consent and undergo regular blood sampling and monitoring of clinical outcomes, including treatment success and side effects. The study tracks various measures of drug levels in the blood and correlates them with patient characteristics and outcomes. Data is anonymized, securely stored, and analyzed to understand drug behavior and its relation to treatment effects and safety over the course of therapy and follow-up.

Infective Endocarditis (IE) is a serious and rare disease with high rates of complications and death. Streptococci from the mouth are the second most common cause of IE. The usual clinical exam combined with Orthopantomogram (OPT) imaging often misses oral infectious foci (OIF), which may contribute to IE. Cone Beam Computed Tomography (CBCT) is thought to detect these oral infections more accurately, but its impact on oral health in IE patients has not been studied before. This trial compares two approaches to oral examination in patients hospitalized for IE: the standard clinical exam with OPT and the newer clinical exam with CBCT. Participants will be randomly assigned to either the OPT group or the CBCT group. The study aims to see if CBCT improves oral health status over 12 months and if it can better detect oral infectious foci. Participants will be monitored over 12 months with evaluations at the start and after one year. These include assessments of oral hygiene, detection of symptomatic and asymptomatic oral infections, and oral health quality of life. Researchers will also track patients' dental follow-up habits and any premature study discontinuation. The main measure is whether CBCT offers superiority in oral health outcomes at 12 months compared to OPT. The study is sponsored by Nantes University Hospital and runs until mid-2028.

Researchers are investigating the clinical and diagnostic features of endocarditis in today's medical context, focusing on how the condition affects a more fragile and older population due to increased percutaneous valve procedures. The study is international and multicenter, designed with two arms: retrospective and prospective. Its goal is to update epidemiological data and better understand endocarditis characteristics and outcomes. The retrospective arm collects anonymous data from patients discharged with endocarditis between 2016 and 2022, examining valve infection details, imaging techniques, treatment approaches, and one-year follow-up outcomes. The prospective arm enrolls patients referred for echocardiography with suspected or confirmed endocarditis over 12 months. It gathers detailed clinical, imaging, management, and follow-up information, including those without endocarditis but at risk, with all prospective participants providing informed consent. Participants will undergo echocardiographic assessments (transthoracic or transesophageal), advanced cardiac imaging, and evaluations by a specialized endocarditis team. Data collected include valve infection characteristics, diagnostic imaging, treatment methods, and one-year outcomes such as death, surgery, stroke, or reinfection. This comprehensive follow-up aims to measure the incidence of endocarditis and related clinical events, supporting improved diagnosis and management strategies.

Researchers are evaluating the effects of clopidogrel compared to aspirin in patients with Staphylococcus aureus bloodstream infections who are already taking aspirin for secondary prevention of cardiovascular events. This open-label randomized controlled trial aims to determine if switching from aspirin to clopidogrel, which may have activity against S. aureus, can improve patient outcomes. The study is a sub-study of the larger Staphylococcus aureus Network Adaptive Platform (SNAP) trial and could lead to a future Phase 3 trial for broader populations. Participants will be randomly assigned to either stop aspirin and start clopidogrel without a loading dose or continue their current aspirin treatment. The trial is designed to compare these two approaches for cardiovascular risk reduction in the context of S. aureus infection. The treatment period coincides with enrollment in the SNAP trial, and patients are monitored throughout. During the study, researchers will assess outcomes at 90 days after enrollment in the SNAP trial, focusing on a ranking system called the Desirability of Outcome Ranking (DOOR). Additional measures include clinical failure, adverse events leading to treatment changes, mortality, infectious complications, bleeding events, thromboembolic events, strokes, heart attacks, and other arterial events. Participation involves regular monitoring and data collection as part of the SNAP trial protocol up to the study end date in January 2030.

Researchers are investigating whether adding ertapenem to cefazolin improves treatment outcomes in adults with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. This phase 2 randomized controlled trial builds on previous laboratory and animal studies, as well as small human case series, suggesting potential benefits of this drug combination. The study is a sub-study of the larger Staphylococcus aureus Network Adaptive Platform (SNAP) trial and aims to explore clinical success rates by day 5 of treatment. Participants receive either ertapenem 1 gram intravenously once daily infused over 2 hours for 5 days alongside cefazolin or a saline placebo infused daily over 2 hours for 5 days with cefazolin as standard therapy. The study uses quadruple masking to compare the effects of ertapenem plus cefazolin against cefazolin with placebo. The trial will monitor a variety of secondary outcomes including blood culture clearance at 30 days, clinical improvement, length of hospital stay, mortality, and infection complications over periods up to 90 days. Throughout the study, participants will have blood cultures and clinical assessments to evaluate infection clearance and treatment response. Researchers will also monitor for adverse events such as acute kidney injury or seizures within the first week. The total participation timeframe includes outcome assessments up to 90 days after treatment starts. This comprehensive monitoring will help determine if the combination therapy reduces bacteremia duration and improves patient outcomes without increasing risks.

Researchers are evaluating the use of PET/CT imaging with Gallium 68 citrate (68Ga-PET/CT) to diagnose prosthetic valve infective endocarditis, a challenging infection of heart valve replacements. This exploratory Phase 2 study compares the diagnostic accuracy of 68Ga-PET/CT with the standard 18F-fluorodeoxyglucose PET/CT (18FDG-PET/CT), based on final diagnoses determined by expert review after three months using the 2023 European Society of Cardiology criteria. The study aims to address limitations of 18FDG-PET/CT, especially in patients who find it difficult to follow dietary restrictions before the exam. Participants suspected of having infective endocarditis on prosthetic heart valves will undergo both imaging tests, with 68Ga-PET/CT performed either the day before, the same day, or the day after 18FDG-PET/CT. Both scans will be interpreted independently by experienced nuclear medicine physicians who are unaware of the final diagnosis. This allows a direct comparison of the two imaging methods' ability to detect infection. During the study, participants will be followed for three months to confirm the diagnosis through expert panel review using clinical, microbiological, and imaging data according to ESC 2023 guidelines. Researchers will measure the sensitivity of 68Ga-PET/CT for detecting prosthetic valve infection and compare its accuracy and agreement with the standard 18FDG-PET/CT. Safety and interpretation consistency between readers will also be monitored throughout the observation period.