[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sepsis-bacterial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sepsis-bacterial":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,80,106,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100549918","phase-4-therapeutic-options-for-crab-100549918",false,"NCT06440304","Therapeutic Options for CRAB","Therapeutic Strategies for Carbapenem-Resistant Acinetobacter Baumannii Infections: Study Protocol","TheraCRAB","Inclusion Criteria:\n\n* Surgical patients (abdominal, vascular, and polytraumatized patients)\n* Older than 18 years\n* Require postoperative treatment in the ICU\n* A positive sample (surveillance or diagnostic) for A. baumannii with signs of systemic infection\n\nInfection will be defined as a diagnostic microbiologically positive sample for A. baumannii and a surveillance microbiologically positive sample for A. baumannii with signs of systemic infection (elevated CRP, leukocytes, and body temperature).\n\nColonization will be defined as a positive surveillance microbiological sample for A. baumannii in the absence of signs of systemic infection (normal CRP, leukocytes, and body temperature).\n\nExclusion Criteria:\n\n* Allergy to the study medications\n* Positive surveillance swabs for A. baumannii without signs of systemic infection\n* Positive findings (surveillance or diagnostic) for carbapenem-sensitive A. baumannii\n* Refusal to participate in the research","ALL","18 Years","90 Years",{"count":21,"type":22},108,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","CRAB infections in ICUs are on the rise, leading to higher morbidity, mortality, and healthcare costs due to resistance to most antibiotics, including carbapenems. The main resistance mechanisms include carbapenemases, efflux pumps, and changes in the bacterial cell wall.\n\nCurrent treatments include polymyxins (Colistin, Polymyxin B), which are effective but can lead to resistance, aminoglycosides (Amikacin, Gentamicin), which are limited by resistance, and tetracyclines (Tigecycline, Eravacycline), which are effective against CRAB. Fosfomycin is effective in combination treatments, and combination therapy (e.g., colistin with sulbactam, fosfomycin, or eravacycline) can enhance outcomes.\n\nPrevious research shows promise for combination therapies, improving treatment efficacy and reducing mortality. New regimens are being studied to find optimal combinations. Individualized dosing is crucial, considering patient-specific factors like age, weight, and renal function. Adjustments depend on the infection site and comorbidities.\n\nStrict infection control and antimicrobial stewardship programs (ASPs) are essential. ASPs focus on optimizing antibiotic use and reducing resistance through education and surveillance. Future directions include continued research for new drugs or combinations and strategies to overcome resistance and improve treatment efficacy.\n\nStudy goals include achieving negative samples after 10 days of therapy, 30-day survival, discharge rates, reduced SOFA scores, and improved clinical and radiological findings. A randomized study will compare colistin combined with fosfomycin, ampicillin\u002Fsulbactam, and eravacycline.\n\nIn summary, treating CRAB infections is complex, requiring combination therapy, individualized dosing, and strict infection control measures.",[28,29],"Infections, Bacterial","Sepsis Bacterial",[31,32,33,34,35,36,37,38],"Carbapenem-resistant Acinetobacter baumannii (CRAB)","Intensive Care Unit (ICU) infections","Polymyxins (colistin)","Combination antimicrobial therapy","Antimicrobial resistance mechanisms","Fosfomycin","Eravacyclin","Ampicillin\u002Fsulbactam","RECRUITING","2026-01-16",{"date":42,"type":43},"2026-01-21","ACTUAL",{"date":45,"type":43},"2025-01-30",{"date":47,"type":22},"2027-02",{"name":49,"class":50},"Clinical Hospital Centre Zagreb","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":51},"100602637","prospective-validation-of-grady-a-machine-learning-model-for-early-sepsis-and-bacteremia-detection-in-icu-patients-100602637","NCT07126106","Prospective Validation of GRADY: A Machine Learning Model for Early Sepsis and Bacteremia Detection in ICU Patients","Prospective Validation of the GRADY Bacteremia\u002FSepsis Prediction Model in Intensive Care Unit Patients: Clinical Performance and Feasibility as an Early Warning System","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* ICU stay of 48 hours or longer\n* Patients from whom blood cultures were obtained during routine monitoring\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* ICU stay shorter than 48 hours\n* Patients without blood cultures",{"count":60,"type":22},55,"12 Months","OBSERVATIONAL","This study aims to prospectively validate the GRADY prediction models, which use machine learning algorithms to estimate the risk of gram-negative bacteremia and sepsis in intensive care unit (ICU) patients based on routinely collected vital signs and laboratory data. Sepsis, a life-threatening condition associated with high ICU mortality, requires early diagnosis and treatment-yet current diagnostic methods relying on blood cultures are time-consuming. Existing scoring systems such as SOFA, SIRS, and NEWS2 often lack sufficient sensitivity and specificity in early sepsis detection. Unlike traditional tools, the GRADY models seek to provide earlier and more accurate risk stratification. This study will compare the clinical performance of GRADY models against standard scoring systems and explore their integration as early warning tools to support rapid intervention and improve outcomes in critical care.",[65,29],"Bacteremia",[67,68,69,70],"Bloodstream Infection","sepsis","Machine Prediction Methods","external validation","2025-08-15",{"date":73,"type":43},"2025-08-17",{"date":75,"type":43},"2025-02-01",{"date":77,"type":22},"2026-01-01",{"name":79,"class":50},"Sisli Hamidiye Etfal Training and Research Hospital",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":87,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":51},"100553890","clinical-outcomes-and-inflammatory-responses-in-viral-vs-bacterial-sepsis-100553890","NCT06491966","Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis","Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis: A Retrospective Cohort Study in ICU Patients","Inclusion Criteria:\n\n1. Patients diagnosed with sepsis according to Sepsis 3.0 criteria.\n2. Patients with confirmed bacterial sepsis based on positive bacterial cultures.\n3. Patients with confirmed viral sepsis, specifically COVID-19, diagnosed via RT-PCR for SARS-CoV-2 for viral group and negative for bacterial group.\n4. Patients aged 18 years and older.\n5. Patients admitted to the ICU during the study period.\n\nExclusion Criteria:\n\n1. Patients with mixed bacterial and viral infections.\n2. Patients with sepsis not meeting the Sepsis 3.0 criteria.\n3. Patients who received immunomodulatory therapies other than standard treatments (e.g., investigational drugs).\n4. Pregnant or breastfeeding women.",{"count":88,"type":22},300,"This observational cohort study aims to compare clinical outcomes and inflammatory responses between patients with viral sepsis, specifically COVID-19-associated sepsis, and those with bacterial sepsis. Conducted at Sichuan Provincial People's Hospital, the study will retrospectively analyze data from ICU patients admitted between July 2021 and December 2023. The primary objective is to identify reliable biomarkers and diagnostic methods to improve patient outcomes through personalized diagnostic and therapeutic strategies.",[91,29,92,93,94,95,96],"Sepsis","Viral Sepsis","Inflammatory Response","Cytokine Storm","COVID-19","MODS","2024-07-08",{"date":99,"type":43},"2024-07-09",{"date":101,"type":43},"2024-04-02",{"date":103,"type":22},"2024-07-10",{"name":105,"class":50},"Sichuan Provincial People's Hospital",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":18,"enrollmentInfo":115,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100517534","molecular-culture-for-the-diagnosis-of-pediatric-sepsis-100517534","NCT06018792","Molecular Culture for the Diagnosis of Pediatric Sepsis","Children's Health Assessment and Molecular Pathogen Identification for Optimized Novel Sepsis Therapy","CHAMPIONS","Inclusion Criteria:\n\n* Undergoing collection of blood for a conventional blood culture as part of standard care OR\n* Having undergone sepsis evaluation collection of blood for a conventional blood culture as part of standard care in the past 72 hours\n\nExclusion Criteria:\n\n* Apart from an age criterion, there are no strict exclusion criteria. However, for the analysis of the secondary outcome (I.e. the testing of diagnostic accuracy of both MC as well as conventional culture for clinical sepsis), we plan to exclude all children who ultimately have a clear alternative cause for clinical illness that does not directly result from bacteraemia or bacterial sepsis. This will remain true in the case of conventional culture positivity, either when considered a contaminant as well as when considered a contributing factor in the presence of any of the causes of clinical illness mentioned below. A potential subject who meets any of the following criteria will be excluded from participation in this study These causes include, but are not limited to:\n* In case of the potential inclusion of a neonate suspicious for EOS, confirmed congenital infection with TORCHES (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes) will lead to exclusion particularly for the neonatal population\n* Auto inflammatory disease\n* Hemophagocytic syndrome\n* SIRS (Systemic Inflammatory Response Syndrome following a severe viral infection","0 Years",{"count":116,"type":22},1835,"Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the symptoms are often unclear and can also occur in children who are not sick. To determine whether there is an infection, a little blood is currently taken for a blood test (the blood culture) to investigate whether there is a bacteria in the blood. However, it often takes at least 36 hours before the results of this blood culture are available. That is why antibiotics are usually started immediately to treat the possible infection.\n\nHowever, it often turns out that the blood culture is negative after 36 hours, which means that no bacteria have been found in the blood. Usually the antibiotics are then stopped because it turns out that there was no infection at all. There is currently no good test that can predict whether (newborn) children have an infection or not. That is why too many children are currently wrongly receiving antibiotics. These antibiotics can damage the healthy bacteria in the intestines. There are many billions of 'beneficial bacteria' in the intestine. These play an important role in the digestion of food and protect against external infections. Antibiotics aim to kill bacteria that cause inflammation or infection. Unfortunately, antibiotics also kill some of these beneficial bacteria. In addition, unnecessary use of antibiotics contributes to antibiotic resistance. The aim of this research is to investigate whether Molecular Culture, a PCR based test that can identify bacterial pathogens in bodily fluids within 4 hours, has greater accuracy than traditional culturing techniques for bacteria in blood. If proven, this could lead to faster identification or exclusion of sepsis in children.",[91,29,119,120,121,122],"Sepsis, Neonatal","Infection, Bacterial","Antibiotic Side Effect","Microbial Colonization","2024-04-09",{"date":125,"type":43},"2024-04-10",{"date":127,"type":43},"2024-03-10",{"date":129,"type":22},"2027-11-01",{"name":131,"class":50},"Jip Groen",2,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"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":142,"type":22},820,[144],"NA","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.",[147,148,29,67,149,150,91],"Staphylococcus Aureus Bacteremia","Staphylococcus Aureus Septicemia","Staph Sepsis","Staphylococcus Aureus Infection",[152,147,148,91,29,149,150,67,153,154,155,156,157,158,159],"Staphylococcus","Staphylococcus Aureus Bacteraemia","PET","PET\u002FCT","PET-CT","Positron Emission Tomography","Positron Emission Tomography\u002FComputed Tomography","Diagnostic Imaging","NOT_YET_RECRUITING","2023-05-10",{"date":163,"type":43},"2023-05-15",{"date":165,"type":22},"2023-09",{"date":167,"type":22},"2026-07",{"name":169,"class":50},"University College, London"]