[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bloodstream-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bloodstream-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,47,86,117,146,173,199,224,247,275,297,324],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100651551","clinical-impact-of-a-machine-learning-decision-support-system-for-empirical-antibiotic-therapy-100651551",false,"NCT07762378","Clinical Impact of a Machine Learning Decision Support System for Empirical Antibiotic Therapy","Clinical Impact of a Machine Learning Decision Support System for Empirical Antibiotic Therapy: A Prospective Quasi-Experimental Study","Inclusion Criteria:\n\n* Adult patients (aged ≥18 years)\n* Admitted to the Nephrology, Oncology or ICU wards\n* Diagnosis of sepsis, pneumonia and\u002For UTI\n* Empirical antibiotics prescribed\n\nExclusion Criteria:\n\n* informed consent obtained \\> 48 hours since the infection onset\n* beta-lactam allergy\n* infection syndrome other than sepsis, pneumonia or UTI\n* confirmed no-bacterial infection\n* death within the first 48 hours of inclusion or imminent risk of death at time of the inclusion\n* pregnancy and\u002For breastfeeding\n* inclusion in a clinical trial of antimicrobial treatment","ALL","18 Years",{"count":19,"type":20},486,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this quasi-experimental study is to analyze if a Machine Learning Clinical Decision Support System can improve the empirical antibiotic treatment in patients with pneumonia, urinary tract infection and \u002F or sepsis.\n\nThe main questions it aims to answer are:\n\n* Primary outcome: clinical success defined as clinical cure (resolution of all signs and symptoms related to infection); no complications until day 30 (recurrence, or development of adverse events- AEs-); no new acquisition of MDROs; and survival at day 30.\n* Secondary outcomes: a subgroup analysis of the primary outcome according to the department participants, infectious syndrome, severity of the infection assessed by the SOFA score, and in microbiological confirmed infections. In microbiological confirmed infections, desirability of Outcome Ranking (DOOR) for the Management of Antimicrobial Therapy (MAT) according to the beta-lactam classification\n\nResearchers will compare a pre-intervention group with a post-intervention to see if improve in the DOOR MAT score\n\nParticipants in the post-intervention group will:\n\n• Received empirical antibiotic therapy prescribed by their treating physicians according to the machine-learning recommendations",[26,27,28],"Pneumonia - Bacterial","Urinary Tract Infection Bacterial","Bloodstream Infection",[30,31,32,33,34],"antibiotics","empiric therapy","clinical decision support system","multidrug resistant microorganism","antimicrobial stewardship","NOT_YET_RECRUITING","2026-08-08",{"date":38,"type":39},"2026-08-13","ACTUAL",{"date":41,"type":20},"2026-09",{"date":43,"type":20},"2027-09",{"name":45,"class":46},"Instituto de Investigación Sanitaria Gregorio Marañón","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100624287","phase-3-prediction-and-prevention-of-bloodstream-infections-after-kidney-transplantation-100624287","NCT07407673","Prediction and Prevention of Bloodstream Infections After Kidney Transplantation","Prediction and Prevention of Bloodstream Infections After Kidney Transplantation - The PREDICT Study","PREDICT","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Kidney transplant recipient.\n3. Able to provide written informed consent.\n4. ≥1 urine sample with bacteriuria ≥10\\^5 CFU\u002FmL (excluding fungi) within first month post-transplantation.\n\nExclusion Criteria:\n\n1. Known strictures in the esophagus and\u002For obstructions in the gastrointestinal tract including diabetes gastroparesis.\n2. Known hypersensitivity or allergy to β-lactam antibiotics.\n3. Known or suspected genetic metabolism anomalies in the carnitine metabolism, including carnitine transporter defect or organic acidurias such as methylmalonic aciduria or propionic acidaemia.\n4. Individuals of Faroese descent (defined as both biological parents born in the Faroe Islands).\n5. Porphyria.\n6. Current treatment with valproic acid, valproate or other medications liberating pivalic acid.\n7. Current treatment with probenecid.\n8. Current treatment with methotrexate.\n9. Ongoing dialysis one month post-transplantation.\n10. Pregnancy or breastfeeding.",{"count":56,"type":20},180,[58],"PHASE3","Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Some of these infections can spread to the bloodstream and cause serious illness, hospitalization, loss of kidney function, or death. Currently, there is no established strategy to prevent these serious bacterial infections in kidney transplant recipients who are at highest risk.\n\nThe PREDICT study is investigating whether a low daily dose of the antibiotic pivmecillinam can reduce the risk of bacterial urinary tract infections and bloodstream infections after kidney transplantation. The study focuses on kidney transplant recipients who have bacteria detected in their urine during the first month after transplantation, as previous research suggests that these patients have a particularly high risk of developing serious infections later.\n\nIn this randomized, double-blind, placebo-controlled trial, 180 adult kidney transplant recipients will be assigned by chance to receive either pivmecillinam or a matching placebo from 1 to 6 months after transplantation. Neither participants nor study staff will know which treatment has been assigned during the study. All participants will continue to receive standard post-transplant care and monitoring.\n\nThe main goal of the study is to determine whether prophylactic pivmecillinam can reduce the occurrence of infections caused by Enterobacterales bacteria, including urinary tract infections and bloodstream infections, during the first 6 months after transplantation. The study will also evaluate the effects of treatment on serious clinical outcomes, safety, quality of life, antimicrobial resistance, and long-term kidney transplant outcomes.\n\nThe study hypothesis is that targeted antibiotic prophylaxis with pivmecillinam in kidney transplant recipients at increased risk of infection will reduce the incidence of Enterobacterales urinary tract infections and bloodstream infections during the high-risk period after transplantation compared with placebo.",[61,28,62,63,64,65,27,66,67],"Kidney Transplant Infection","Kidney Transplant","Kidney Transplant Recipients","Infection","Urinary Tract Infection(UTI)","Antibiotic Prophylaxis","Bacteriuria",[69,70,71,72,73,74,75],"kidney transplantation","bloodstream infection","urinary tract infection","antibiotic prophylaxis","pivmecillinam","bacteriuria","Enterobacterales","2026-07-20",{"date":78,"type":39},"2026-07-22",{"date":80,"type":20},"2027-01-01",{"date":82,"type":20},"2041-07",{"name":84,"class":46},"Susanne Dam Nielsen, MD, DMSc",3,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100621554","antibiotic-duration-and-outcomes-in-high-risk-febrile-neutropenia-patients-100621554","NCT07372131","Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients","Appropriate Management of Bacteriemic Febrile Neutropenia in High-Risk Hematological Patients. Relationship Between Duration of Antibiotic Administration, Outcome and Resistance Profile","PERaSTrA","Inclusion Criteria:\n\n* Diagnosed with a hematologic malignancy that is candidate for treatment with chemotherapy or bone marrow transplantation or chimeric antigen receptor T cell therapy (CAR-T)\n* Diagnosis of febrile neutropenia defined according to the guidelines of the Infectious Disease Society of America, IDSA; ref: Freifeld, A.G., et al., Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis, 2011. 52(4): p. e56-93.) as: Fever: single record of oral temperature \\>=38.3°C or a temperature \\>=38.0°C sustained over a period of one hour; Neutropenia: absolute neutrophil count \\\u003C 1000 cells\u002FmicroL; Expected duration of neutropenia \\>= 7 days\n* Diagnosis of bacteraemia defined by positive blood cultures (at least 1 vial positive for a non-contaminating microorganism)\n* Isolation of Gram-Negative species\n\nExclusion Criteria:\n\n* Contextual diagnosis of pneumonia\n* Contextual diagnosis of intra-abdominal infection, in particular: neutropenic enterocolitis\u002Ftyphlitis or biliary tract infection\n* Persistently positive blood cultures at randomization\n* Any condition that endangers the safety of the patient based on the judgment of the treating physician",{"count":95,"type":20},172,[23],"The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia.\n\nThe main questions it aims to answer are:\n\n* Can a personalized antibiotic duration increase the number of days free from anti-Gram-negative therapy within 28 days without compromising patient safety?\n* How does the duration of antibiotic therapy (short vs. prolonged) affect the rate and modality of gut microbiota reconstitution?\n\nResearchers will compare:\n\n* Group A (Personalized Duration): Antibiotics are stopped after the patient maintains clinical stability (no fever and stable vital signs) for 72 consecutive hours.\n* Group B (Standard of Care): Antibiotics are continued for a standard duration, typically at least 10 days, based on current clinical surveys and physician decision.\n\nParticipants will:\n\n* Be randomized to receive either the personalized or the standard duration of antibiotic therapy once a Gram-negative infection is confirmed in the blood.\n* Be monitored for 28 days to assess for new fever episodes, recurrence of infection, and overall survival.\n* If participating in the microbiological sub-study, provide biological samples (blood, feces, and rectal swabs) at specific time points (at the onset of fever, at the end of treatment, and at day 28).\n* Undergo specialized laboratory testing (Whole Metagenomic Sequencing) on the collected samples to evaluate the evolution of their intestinal and blood microbiota and the presence of antibiotic-resistant genes.",[28,99,100,101],"Gram Negative Infections","Bacteraemia Caused by Gram-Negative Bacteria","Febrile Neutropenia (FN)",[103,28,104,105],"Antibiotics","Hematological patients with febrile neutropenia","Gram-negative","RECRUITING","2026-07-14",{"date":109,"type":39},"2026-07-15",{"date":111,"type":39},"2026-01-25",{"date":113,"type":20},"2028-11-30",{"name":115,"class":46},"Valeria Cento",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":116},"100630726","the-impact-of-fast-antimicrobial-sensitivity-testing-tools-on-stewardship-antibiotic-and-clinical-outcome-act-fast-100630726","NCT07491419","The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)","The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome: a Randomized Clinical Trial Within an Adaptive Platform Trial for Patients With Bloodstream Infections","ACT-FAST","Inclusion Criteria:\n\n* Patients admitted to emergency department or hospitalized for any cause in participating hospitals with clinically suspected BSI and positive blood culture.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Have previously taken part in this trial.\n* Concurrently participating in the active phase of a study considered incompatible.\n* Patient with severe or terminal disease with life expectancy shorter than 48 h.\n* Have an existing directive to withhold life-sustaining treatment, in relation to antibiotic use.",{"count":126,"type":20},400,[23],"The ACT-FAST study aims to compare commercially available Rapid Antimicrobial Susceptibility Testing (R-AST) tools with the current standard of care for patients with Bloodstream Infections (BSI). The primary objective is to evaluate whether \"early targeted\" antibiotic prescriptions, guided by these rapid tests, can improve antimicrobial stewardship and patient clinical outcomes.\n\nTo facilitate the evaluation of various diagnostic tools-including those currently on the market and those emerging in the near future-this study utilizes an adaptive clinical trial platform. This flexible design allows for the continuous assessment of different R-AST technologies within a single master protocol, ensuring that the most effective diagnostic strategies are identified efficiently.",[28,130,131,132],"Gram-Negative Infections","Gram-Positive Infections","Bacteremia Sepsis",[134,135,136,132],"Blood Stream Infection","Gram-negative Infections","Gram-positive Infections","2026-06-21",{"date":139,"type":39},"2026-06-24",{"date":141,"type":39},"2026-03-19",{"date":143,"type":20},"2028-03-19",{"name":145,"class":46},"Istituto Clinico Humanitas",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":156,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":116},"100641723","combination-vs-monotherapy-for-stenotrophomonas-maltophilia-infections-100641723","NCT07593547","Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections","Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections: A Multicentre Study Using Target Trial Emulation","EMULATE-Sm","Inclusion Criteria:\n\n* Adult patients\n* S. maltophilia infections\n* Different episodes if a new infection ocurred \\> 30 days since the index episode\n\nExclusion Criteria:\n\n* isolates obtained from patients outside of hospital admission\n* microbiological or clinical colonization\n* hospitalizations shorter than 72 hours since the time zero\n* patients who died in the first 72 hours since the time zero or who were in imminent risk of death\n* polymicrobial infections\n* receipt of inappropriate therapy after the time of the emulated randomization, defined as the absence of in vitro active antimicrobials or the administration of active antimicrobials for less than 48 hours\n* absence of data outcomes",{"count":155,"type":20},790,"60 Days","OBSERVATIONAL","The goal of this multicentre observational study is to analyse the treatment strategies and the outcomes for patients with S. maltophilia infections using target trial emulation methodology. The main question it aims to answer is:\n\n• Does combined therapy achieve better results than monotherapy in treating S. maltophilia infections?\n\nResearchers will compare groups receiving monotherapy and combined therapy to see if there are differences in all-cause 30-day mortality.",[28,26,160],"S Maltophilia Infections",[162,64,163,164],"S. maltophilia","Mortality","Combined therapy","2026-06-14",{"date":167,"type":39},"2026-06-16",{"date":169,"type":39},"2026-03-06",{"date":171,"type":20},"2026-12-31",{"name":45,"class":46},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":116},"100637503","sulbactam-durlobactam-in-crab-infection-a-real-world-cohort-study-100637503","NCT07601711","Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study","This is a Single-center Real-world Observational Cohort Study of Sulbactam-Durlobactam for Carbapenem-Resistant Acinetobacter Baumannii Infections: Effectiveness, Safety, and Exposure-Response Analysis","SD-CRAB","Inclusion Criteria:\n\n* Age ≥18 years.\n* Hospitalized patients receiving anti-CRAB antimicrobial therapy, including:\n\n  1. patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection based on microbiological testing in combination with clinical evidence of infection; or\n  2. transplant recipients with donor-derived CRAB colonization or infection who receive early targeted antimicrobial therapy.\n* Treatment initiation time can be clearly determined.\n* Availability of clinical outcome data.\n\nExclusion Criteria:\n\n* Colonization without evidence of active infection.\n* Missing key clinical data.\n* Inability to determine treatment initiation time.\n* Pregnancy or lactation.\n* Patients considered unsuitable by investigators.",{"count":182,"type":20},200,"This is a multicenter real-world observational cohort study designed to evaluate the effectiveness and safety of sulbactam-durlobactam in patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections. Patients receiving sulbactam-durlobactam will be compared with those receiving other anti-CRAB regimens during the same period.\n\nThe primary outcomes are 28-day all-cause mortality and clinical failure. Secondary outcomes include microbiological clearance, recurrence, length of hospital and ICU stay, duration of mechanical ventilation, and adverse events.\n\nTo reduce confounding inherent in observational studies, propensity score methods, including matching and inverse probability weighting, will be applied. A nested therapeutic drug monitoring (TDM) sub-cohort will be established to explore the relationship between drug exposure and clinical outcomes.",[185,28,186,187],"Carbapenem-Resistant Acinetobacter Baumannii Infection","Pneumonia","Sepsis",[189],"CRAB Infection","2026-05-19",{"date":192,"type":39},"2026-05-22",{"date":194,"type":39},"2025-11-11",{"date":196,"type":20},"2027-11-11",{"name":198,"class":46},"Sichuan Provincial People's Hospital",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":207,"targetDuration":209,"studyType":157,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":223},"100556893","clinical-performance-study-of-microbio-infectid-bsi-for-detection-of-bacteria-and-yeast-with-patient-blood-samples-100556893","NCT06531031","Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples","Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast","IID-BSIqPCR","Inclusion Criteria:\n\n* Male or female of neonates (less than 1 month of age), paediatrics (between 1 month and 17 years of age) or adults (≥18 years of age).\n* Admitted to ICU, Emergency Department, or other medical wards for acute illness with medical decision to perform blood culture for suspicion of bloodstream Infection.\n* Two additional EDTA blood sample\u002Fs collected from one anatomical site and at the same time as blood culture (two EDTA samples to be collected where possible).\n* EDTA blood volume is ≥1mL.\n* EDTA blood sample is stored according to Microbio's stability requirements.\n\nExclusion Criteria:\n\n* No suspicion of blood stream infection (BSI).\n* Any inclusion criterion not met.\n* Multiple EDTA blood samples from the same patient.\n* EDTA blood sample not obtained from the same anatomical site and at the same time as the blood culture sample.\n* Subject has had an antimicrobial drug administered through the same port or central line as is used to collect the specimen.\n* EDTA blood samples that have not been stored according to Microbio's sample stability requirements.\n* EDTA blood volume \\\u003C1mL.",{"count":208,"type":20},1500,"1 Day","The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture.\n\nThe objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.",[28,187,212],"Septic Shock","2025-07-20",{"date":215,"type":39},"2025-07-24",{"date":217,"type":20},"2025-08",{"date":219,"type":20},"2026-11",{"name":221,"class":222},"Microbio Co Ltd","INDUSTRY",8,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":233,"studyType":157,"phases":4,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":116},"100599271","european-prospective-bloodstream-infection-cohort-100599271","NCT07082322","European Prospective Bloodstream Infection Cohort","EPIC-BSI","Inclusion Criteria:\n\n* EPIC-BSI Registry: Positive blood cultures result. For each patient only the first positive blood culture result during 90 days would be counted.\n* EPIC-BSI Diagnostic study: Centre recruiting for the EPIC study with access to microbiological and clinical data.\n* EPIC-BSI Management study - Regular dataset: First two BSI cases per month of (at least two or three) target pathogens (S. aureus, E. faecalis\u002FE. faecium, E. coli, Klebsiella spp., P. aeruginosa, A. baumanii, Streptococcus spp.)\n\nExclusion Criteria:\n\n* EPIC-BSI Registry: Non-comprehensive documentation and reporting of BSI cases, Age \\\u003C 18 years\n* EPIC-BSI Diagnostic Study: EPIC BSI centre does not participate in the EPIC BSI Diagnostic Study arm\n* EPIC-BSI Management Study: Non-comprehensive documentation and reporting of BSI cases; Age \\\u003C 18 years; For Follow-up part: Patient with dementia or other progressed neurological or vigilance disorder without contact details of legal representative, which makes follow-up unfeasible",{"count":232,"type":20},40000,"90 Days","Background:\n\nBloodstream infections (BSIs) and sepsis continue to pose significant public health challenges, contributing to high morbidity and mortality worldwide. According to the Global Burden of Diseases Study, BSIs and sepsis are associated with approximately 20% of global deaths. However, the clinical characteristics of BSIs have evolved over recent years, showing significant variability across different countries and continents. The diversity in management standards across regions further complicates the generalization and transferability of research findings. Despite the critical need for comprehensive data, BSI research in Europe remains fragmented, often limited to national-level studies.\n\nProject Aim:\n\nThe EPIC-BSI project aims to address these challenges by establishing a multinational, collaborative bloodstream infection cohort across Europe and globally. The primary objectives are to:\n\n* Integrate national BSI research into a cohesive multinational cohort that enable large-scale comparative research by standardizing BSI incidence data, diagnostic and therapeutic approaches, and patient outcomes across European countries and beyond.\n* Monitor shifts in BSI characteristics, including the emergence of multi-drug resistant organisms, and changes in risk groups, diagnostics, and therapies.\n* Create a foundation for future studies and collaborations, such as integrating BSI data with international antibiotic usage, population data, health policy data, or by biobanking blood-borne pathogens for sequencing.\n\nThe study is divided into three arms focusing on BSI epidemiology (EPIC-BSI registry), diagnostics (EPIC-BSI Diagnostic Study) and management (EPIC-BSI Management study). The EPIC-BSI Management study is partitioned in different levels of data contribution to reduce barriers for centres and enable broad participation.\n\nSpecific Objectives and Endpoints:\n\nEPIC-BSI Registry:\n\n* Primary aim\u002Fendpoint: Establish an international prospective BSI cohort with anonymized inclusion of all BSI cases from participating centres allowing estimation of BSI incidence by pathogen in the participating centres.\n* Secondary aims\u002Fendpoints:\n\n  * Analyse the incidence of BSIs across different settings and countries.\n  * Monitor changes in patient demographics (age, gender) and acquisition modes.\n  * Track shifts in antimicrobial resistance patterns.\n  * Review effects of infection control practices on MDRO-BSI frequency\n\nEPIC-BSI Diagnostic Study:\n\n* Primary aim\u002Fendpoint: Biannual evaluation of diagnostic procedures and standards regarding BSI at participating centres\n* Secondary aims\u002Fendpoints:\n\n  * Assess the availability and use of (new) clinical and microbiological diagnostics.\n  * Identify gaps in diagnostic practices and time lags between scientific evidence, guideline publication and clinical implementation of new diagnostic utilities.\n\nEPIC-BSI Management Study:\n\n* Primary aim\u002Fendpoint: Analyse clinical data from BSI cases to evaluate management practices regarding the effect on in-hospital mortality and outcome on day 90 after onset incl. patient-reported outcomes (Desirability-of-outcome-ranking (DOOR) or health-related quality of life metrics)\n* Secondary aims\u002Fendpoints:\n\n  * Identify differences in clinical management across countries and hospital types.\n  * Analyse the impact of antimicrobial resistance patterns on clinical outcomes.\n  * Evaluate the effectiveness of different established therapeutic regimens.",[28],[237,238],"Registry","Therapeutical management","2025-07-15",{"date":215,"type":39},{"date":242,"type":20},"2025-09-01",{"date":244,"type":20},"2031-01-01",{"name":246,"class":46},"University Hospital Freiburg",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100593254","phase-4-optimising-treatment-for-severe-gram-negative-bacterial-infections-100593254","NCT07004049","Optimising TREATment for Severe Gram-Negative Bacterial Infections","TREAT-GNB [CR-GNB]","TREAT-GNB","Inclusion Criteria:\n\nA: Bloodstream infections\n\na) Suitable for at least 2 antibiotic regimens in the site randomisation list\n\n1. Growth of Gram-negative bacilli identified from blood culture(s)\n2. Receiving or planning to receive intravenous antibiotics\n3. Expected time from blood culture sampling to randomisation is ≤ 96 hours.\n\nOR\n\nB: Ventilator-associated pneumonia \u002F hospital-acquired pneumonia a) Suitable for at least 2 antibiotic regimens in the site randomisation list b) Infection syndrome definitions\\^( (US Centers for Disease Control and Prevention National Healthcare Safety Network)3: i) At least one of the following:\n\n1. temperature \\> 38 °C\n2. white blood cell count ≥ 12,000 cells\u002Fmm3 (12 x 109\u002FL, 12 x 103\u002FµL) or ≤ 4,000 cells\u002Fmm3 (4 x 109\u002FL, 4 x 103\u002FµL)\n3. altered mental status with no other causes in \\> 70 years old; AND ii) Two or more chest imaging tests demonstrating at least one of the following:\n\n1\\) new and progressive OR progressive and persistent infiltrate 2) new and persistent OR progressive and persistent consolidation 3) new and persistent OR progressive and persistent cavitation; AND iii) At least two of the following:\n\n1. new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements\n2. new onset or worsening tachypnoea or dyspnoea\n3. rales or bronchial breath sounds\n4. worsening gas exchange defined by oxygen desaturations (e.g., PaO2\u002FFiO2 \\\u003C 240), increased oxygen requirements or increased ventilation demand.\n\n   c) Hospital admission \\> 48 hours d) Predominant growth of Gram-negative bacilli identified from respiratory tract specimen(s)\\*; e) Receiving or planning to receive intravenous antibiotics f) Expected time from respiratory culture sampling to randomisation is ≤ 96 hours\n\n   AND\n\n   C: CR-GNB antibiotic backbone domain\n\n   a) Gram-negative bacilli belonging to Acinetobacter baumannii-calcoaceticus complex, Pseudomonas aeruginosa or Enterobacterales b) Carbapenem resistance in isolate detected - i) Phenotypically via conventional microbiology testing: meropenem \u002F imipenem \u002F ertapenem resistance; OR ii) Genotypically via PCR or next generation sequencing: presence of genes associated with carbapenemase production (eg. blaNDM, blaKPC, blaIMP, blaIMI, blaVIM, blaOXA-48-like).\n\n   Exclusion Criteria:\n   1. Treating team deems enrolment in the study is not in the best interest of the patient\n   2. Patient is on end-of-life care\n   3. Patient is incarcerated in a correctional facility\n   4. Participation in any interventional study activities outlined in the TREAT-GNB study within the last 90 days\n   5. Pregnant women and children\n\n      OR\n   6. Polymicrobial bloodstream infection",{"count":256,"type":20},600,[258],"PHASE4","TREAT-GNB is an innovative trial to expedite the evaluation of various antibiotic choices and treatment strategies for severe multidrug-resistant Gram-negative bacterial infections, specifically bloodstream and lower respiratory tract infections. This approach combines platform trial elements with adaptive clinical designs to streamline the evaluation of various treatment options and optimise resource utilisation. The overall aim of the TREAT-GNB platform trial is to identify interventions that improve survival in patients with severe infections due to Gram-negative bacteria.\n\nIn the CR-GNB silo of TREAT-GNB, the primary objective is to quantify the effect on all-cause mortality at 28 days of a range of interventions in patients with bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by CR-GNB.",[28,261,262,263,264],"Ventilator Associated Bacterial Pneumonia","Hospital Acquired Bacterial Pneumonia","Carbapenem Resistant Bacterial Infection","Multidrug Resistance","2025-05-26",{"date":267,"type":39},"2025-06-04",{"date":269,"type":39},"2025-04-21",{"date":271,"type":20},"2028-12-31",{"name":273,"class":46},"National University of Singapore",41,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":21,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":116},"100560370","the-clinical-impact-of-cobas-eplex-blood-culture-panels-for-the-diagnosis-of-bacteremia-and-fungemia-100560370","NCT06576258","The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia","Inclusion Criteria:\n\n* Patients with onset of BSI at the emergency department or general wards\n* Patients hospitalized from blood draw (at least 24h)\n* For pediatric patient only BSI episodes caused by gram-negative organisms\n\nExclusion Criteria:\n\n* Patients deceased at the time of the positive blood culture\n* Patients in comfort care or with an estimated survival before sepsis of less than one month\n* Patients with positive blood culture bottles within the past 14 days\n* Patients for which the blood bottles are highly suspected of contaminants (bacterial species belonging to potential skin commensals or known environmental contaminants) and in the absence of any other site of infections.",{"count":182,"type":20},[23],"A quality improvement study on the diagnostics and clinical management of bloodstream infection episodes. Patients of all ages and genders with positive blood cultures collected for standard patient care are included in the study. In the intervention group of patients, positive blood cultures will be analysed with the cobas® eplex (Roche) blood culture panels in addition to conventional, standard-of-care (SOC) culture methods. The control group will include patients with positive blood cultures analysed using conventional, standard-of-care (SOC) culture methods. The study aims to determine the effect of rapid molecular testing using the cobas® eplex blood culture panels (Roche) in the clinical management of bloodstream infections and more specifically the effect of the eplex result on the time to most effective\u002Ftargeted antibiotic treatment. The primary objective is to investigate the difference in time to most effective antibiotic treatment between the control and intervention group. The secondary aims are to analyze the concordance of results and compare the user-friendliness, hands-on time and turnaround times of the eplex to the SOC culture methods as well as to compare the difference in the length of stay, antibiotic intensity score at 96h after Gram staining and patient outcome (30-day, all cause mortality and 30-day readmission) in the control and intervention group.",[28],[286,70,287],"syndromic diagnostic testing","cobas eplex","2025-03-27",{"date":290,"type":39},"2025-04-02",{"date":292,"type":39},"2024-11-19",{"date":294,"type":20},"2025-12",{"name":296,"class":46},"University Hospital, Antwerp",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":116},"100564088","rapid-molecular-diagnosis-of-sepsis-in-the-intensive-care-unit-100564088","NCT06624618","Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit","Rapid Molecular Detection of Sepsis in Whole Blood","RADOS","Inclusion Criteria:\n\n-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.\n\nExclusion Criteria:\n\n-N\u002FA",{"count":306,"type":20},300,"Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.",[187,28],[310,311,312,187,313,314],"Culture-free","Whole blood","Molecular diagnosis","Bloodstream infection","Bacterial DNA","2024-10-01",{"date":317,"type":39},"2024-10-03",{"date":319,"type":39},"2024-05-01",{"date":321,"type":20},"2026-05-01",{"name":323,"class":46},"Maastricht University Medical Center",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":334,"briefSummary":335,"conditions":336,"keywords":342,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":4},"100467006","18-fluorodeoxyglucose-positron-emission-tomographycomputed-tomography-in-s-aureus-bacteraemia-100467006","NCT05361135","18-fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography in S. Aureus Bacteraemia","18-fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography in Staphylococcus Aureus Bacteraemia (Bacteremia\u002FBloodstream Infection); an International, Multicentre, Randomised Control Trial","PET-SAB","Inclusion Criteria:\n\n* Adult (≥18 years of age)\n* Staphylococcus aureus complex grown from ≥1 blood culture\n* Symptoms of S. aureus bloodstream infection\n* Admitted to a participating hospital at the time of eligibility assessment . Agrees to PET\u002FCT\n\nExclusion Criteria:\n\n* Contraindication to PET\u002FCT (including pregnancy\u002Fbreast-feeding)\n* PET\u002FCT in the last 7 days or already planned to occur in the next 7 days\n* Treating team deems enrolment in the study is not in the best interest of the patient\n* Treating team believes that death is imminent and inevitable\n* Patient is for end-of-life care and PET\u002FCT is considered not appropriate",{"count":333,"type":20},820,[23],"Having bacteria in the blood can be very dangerous. This is called bacteraemia (or bacteremia) or bloodstream infection. It can lead to problems across the whole body, which is what happens in sepsis. Bacteria called Staphylococcus aureus (S. aureus) cause one kind of bacteraemia. Up to a third of people with this condition die within three months, even with antibiotics. One reason for such severe problems is that the bacteria can spread almost anywhere in the body, and hide in places where they are very hard to find. When people with S. aureus bacteraemia come into hospital and have had antibiotics, doctors sometimes cannot tell if they still have an infection source (called a 'focus') hiding in their body. The focus can be like an abscess and may need removing or the pus draining out. A focus might be obvious, if there is pain or swelling, or it might be hidden and deep. If these 'foci' can be found, then doctors can treat them and this helps to cure patients.\n\nTo improve survival for patients with these life-threatening infections, it is vital that doctors find the focus of S. aureus bacteraemia as quickly as possible. However, the research team do not know the best way to do this. Most patients with S. aureus bacteraemia have a chest X-ray and a scan of the heart valves. Patients may go to the scanning department lots of times while doctors try to work out where these foci are. This is uncomfortable and takes a lot of time. In about 1 in 5 cases the doctors still cannot find the focus. This is very worrying for patients, their relatives and doctors.\n\nThis study has been designed by researchers, doctors and patient advocates. It aims to work out if fewer patients may die when a specific type of scan called a 'PET\u002FCT' is done quickly, because it finds more foci. To do this the team plan to do a clinical trial in patients with S. aureus bacteraemia. Half of the patients will receive the usual tests that patients currently get and the other half will receive an extra scan as soon as possible. The patients will be chosen randomly (like the flip of a coin) to go into one of the 2 groups. A year into the trial, an independent committee will check the results to make sure the extra scan is finding more foci. If this is the case, the trial will carry on. At the end of the study, we will share the results globally. The findings are expected to change the way this dangerous condition is managed, so patients do better.",[337,338,339,28,340,341,187],"Staphylococcus Aureus Bacteremia","Staphylococcus Aureus Septicemia","Sepsis Bacterial","Staph Sepsis","Staphylococcus Aureus Infection",[343,337,338,187,339,340,341,28,344,345,346,347,348,349,350],"Staphylococcus","Staphylococcus Aureus Bacteraemia","PET","PET\u002FCT","PET-CT","Positron Emission Tomography","Positron Emission Tomography\u002FComputed Tomography","Diagnostic Imaging","2023-05-10",{"date":353,"type":39},"2023-05-15",{"date":355,"type":20},"2023-09",{"date":357,"type":20},"2026-07",{"name":359,"class":46},"University College, London"]