[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infection-in-icu\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infection-in-icu":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,80,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100599525","early-optimization-of-ceftazidime-regimen-in-critical-care-100599525",false,"NCT07085624","Early Optimization of Ceftazidime Regimen in Critical Care","FORTOPTIM_1","Inclusionn criteria:\n\n* Patient hospitalized in intensive care unit for an expected duration of at least 72 hours, with an infection for which initiation of ceftazidime therapy is being considered.\n* Patient with an arterial catheter for blood sampling.\n* Patients affiliated to or entitled under a social security scheme.\n\nExclusion Criteria:\n\n* Pregnant woman, parturient, nursing mother;\n* Person deprived of liberty, hospitalized without consent,\n* Adults under legal protection (guardianship-curatorship)\n* Patients undergoing extra-renal purification or whose CKD-EPI at the start of treatment is less than 15 ml\u002Fmin.","ALL","18 Years",{"count":19,"type":20},128,"ESTIMATED","INTERVENTIONAL",[23],"NA","Hospital-acquired infections, most of which are caused by Gram-negative bacteria, are common in intensive care units and have a major impact on patient prognosis. Patient survival in severe sepsis and septic shock depends on the early administration of appropriate antibiotic therapy, with mortality increasing by 7.6% for each hour of delay, justifying the probabilistic use of broad-spectrum antibiotics such as ceftazidime, an essential betalactamine, particularly used for its activity against Pseudomonas aeruginosa, a frequent pathogen in nosocomial infections.\n\nIt is currently recommended that ceftazidime should initially be administered as a 2g loading dose, followed by maintenance treatment by continuous infusion, at a dose adapted to renal function.\n\nThe recommended dosage regimen, with its 2g loading dose, was developed using the median value of parameters from a pharmacokinetic model. This explains the findings of many critical care studies, which have found that 40-60% of patients initially have concentrations below target with the recommended dosing regimen.\n\nIn the context of critical care, maintaining concentrations within the target therapeutic range is difficult due to variations in the elimination clearance of ceftazidime. Ceftazidime is mainly eliminated by the kidneys. Critical patients may have increased glomerular filtration rate, or, conversely, impaired renal function, with rapid variations in the event of severe infection. This leads to high intra- and inter-individual variability, and increases the risk of antibiotic under- or overdose when the maintenance dose is administered at a fixed dose (6g\u002Fd continuously). This high variability can also be observed in the volume of distribution (capillary leakage, oedema, perfusion volumes, effusions ...).\n\nIn order to propose an individualised dosing regimen, we therefore propose an iterative randomised study to :\n\n* Step 1: FORTOPTIM\\_1 Evaluation of an optimised dosage regimen based on literature data compared with the standard psological regimen.\n* Step 2: FORTOPTIM\\_2 Build a pharmacokinetic model from the prospective data obtained in step 1. Based on this model, an individualised dosage regimen (loading dose and maintenance dose) will be obtained for step 3.\n* Step 3: FORTOPTIM\\_3 Prospectively evaluate in a randomised trial the individualised dosing regimen previously defined (Step 2) by comparing it to the best dosing regimen determined in Step 1 or to the standard dosing regimen if there is no significant difference in Step 1.",[26,27,28,29],"Infection in ICU","Sepsis","Septic Shock","Pseudomonas Aeruginosa Infection",[31,32,33,34],"ceftazidime","intensive care unit","pharmacokinetics","individualised dosing regimen","NOT_YET_RECRUITING","2025-11-21",{"date":38,"type":39},"2025-11-24","ACTUAL",{"date":41,"type":20},"2026-01",{"date":43,"type":20},"2026-11",{"name":45,"class":46},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",8,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100591187","investigating-the-impact-of-sepsis-phenotypes-on-antibiotic-treatment-in-patients-with-severe-pneumonia-and-sepsis-100591187","NCT06977165","Investigating the Impact of Sepsis Phenotypes on Antibiotic Treatment in Patients With Severe Pneumonia and Sepsis","Investigating the Impact of Sepsis Phenotypes on Antibiotic Treatment in Patients With Severe Pneumonia and Sepsis: a Prospective Observational Cohort Study","SIPRES","Inclusion Criteria:\n\n* age ≥ 18 years;\n* admitted to intensive care and receiving at least one-organ supportive care;\n* treated for presumed or confirmed lower respiratory infection;\n* receiving or about to receive piperacillin\u002Ftazobactam as part of standard clinical care;\n* valid informed consent or enrolment through deferred consent pathway appropriate.\n\nExclusion Criteria:\n\n* unlikely to survive 24 hours as judged by the treating physician;\n* study antimicrobial started more than 24 hours prior.",{"count":57,"type":20},119,"OBSERVATIONAL","Aim of the research: To find out why antibiotics work differently in certain patients with severe pneumonia and sepsis.\n\nBackground: Individuals can become very unwell from pneumonia, sometimes requiring admission to hospital or even the intensive care unit (ICU). In some cases, pneumonia can lead to a condition called sepsis, which can be deadly if not treated quickly. In the UK, approximately 30,000 patients die from pneumonia every year. Clinicians use antibiotic injections to treat life-threatening infections such as severe pneumonia. After being injected into the bloodstream, antibiotics quickly spread throughout the body, attacking the infection. Antibiotics are eventually broken down and removed from the body by the kidneys and other organs. However, antibiotics fail to achieve the same consistent result for every patient. This may be to do with the way the antibiotics travel through and are removed from the body, leading to different antibiotic levels in the blood at any one time. Low antibiotic levels can result in worse outcomes and antibiotic resistance. Patients can be grouped based on how their immune system reacts to infections. The SIPRES Study aims to explore if these previously described groups explain the difference in antibiotic levels in patients with severe pneumonia and sepsis.\n\nProcedures: We will study how adult patients with severe pneumonia respond when treated with the most commonly used antibiotic in the ICU called piperacillin\u002Ftazobactam. Alongside information on how quickly patients get better and how long they need to stay in hospital or in ICU, we will collect blood samples to measure antibiotic levels and assess each patient's immune system at two time points during their treatment. This will allow us to measure antibiotic levels in blood at different times and group patients based on their immune system reaction to infection. We will describe the range of antibiotic levels seen in the different immune system reaction groups using mathematical and statistical models.\n\nPatient involvement: We are working closely with people who have experienced severe pneumonia and will work with two patient partners and a patient advisory group to help shape this research. Patient contributors have already shaped the development of the funding application and identified important study outcomes. Patients we have spoken to are concerned over the appropriate dosing of antibiotics and appreciate the need for improved and precise approaches to treating severe infections. Moving forward, patient partners will help finalise the protocol, develop patient and public facing materials, provide their perspective on the study results and shape plans to share the outcomes of the study more broadly.\n\nPotential impact: The SIPRES Study will help identify a group of patients at risk of low antibiotic levels in blood, who are less likely to improve with treatment and more likely to develop antibiotic resistance. Mathematical models that can help clinicians personalise antibiotic dosing for each critically ill patient with severe pneumonia will be developed. Findings have the potential to limit the development of antibiotic resistance and help patients survive and get better faster so that they can return to their normal daily lives. Individualised dosing for patients with low antibiotic levels, as opposed to 'one size fits all' prescribing, also has the potential to more efficiently allocate scarce resources to those who will benefit the most.",[61,62,27,26,63],"Respiration Disorders","Respiratory Failure","Pneumonia",[65,66,67,68,69],"sepsis","pneumonia","therapeutic drug monitoring","beta-lactam antibiotics","piperacillin-tazobactam","2025-05-08",{"date":72,"type":39},"2025-05-18",{"date":74,"type":20},"2025-09-01",{"date":76,"type":20},"2027-09-30",{"name":78,"class":46},"University of Manchester",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":79},"100581096","measurement-of-intestinal-permeability-in-intensive-care-patients-with-single-or-multiple-organ-failure-100581096","NCT06845865","Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure","BLUE-REA","Inclusion Criteria:\n\nPatient with single organ failure, secondary to sepsis, hospitalized in intensive care for a foreseeable duration of \\> 48 hours\n\n* SAPS2 between 20 and 40 at the sixth hour after the diagnosis of organ failure.\n* Consent from the patient or their trusted person.\n* Affiliation to a social security system.\n* Functional digestive tract and possible feeding (per os or via a nasogastric tube whose indication was determined independently of the study's needs).\n\nSecond group of patients with multi-organ failure:\n\n* Multi-organ failure syndrome with at least 2 organ failures, secondary to sepsis.\n* SAPS2 between 60 and 80 at the sixth hour after the diagnosis of organ failure.\n* Consent from the patient or their trusted person.\n* Affiliation to a social security system.\n* Functional digestive tract and possible feeding (conscious patient able to swallow or with a nasogastric tube whose indication was determined independently of the study's needs).\n\nExclusion Criteria:\n\n* Pregnant and breastfeeding women;\n* Minors;\n* Persons under administrative and judicial supervision;\n* Absence of a functional digestive tract (patient unable to swallow and absence of a nasogastric tube, contraindication to enteral feeding);\n* Patients with gastroparesis;\n* Refusal of the patient or their trusted person;\n* Patient with a SAPS2 at the sixth hour after the diagnosis of organ failure \\\u003C 20 or between 40 and 60 or \\> 80.",{"count":88,"type":20},126,"Multivisceral failure syndrome (MVFS) in humans is associated with a very high risk of mortality, ranging between 30 and 50%. This syndrome is associated with significant systemic inflammation and a high risk of bacteremia, the origin of which is not always identified. Among the possible causes of bacteremia, digestive translocation is the most probable but has not been formally proven to date. This translocation is made possible by the numerous cellular and metabolic alterations secondary to MVFS, which can lead to increased intestinal barrier permeability. Intestinal permeability is currently not systematically evaluated in clinical practice in humans.\n\nThis increased intestinal permeability, associated with the presence of inflammatory markers and a septic state, has been studied in several animal models ranging from the fruit fly (Drosophila) to the mouse. These studies have shown a high risk of mortality associated with increased intestinal permeability.\n\nWe propose to use this methodology in intensive care patients with at least one organ failure to investigate the link between increased intestinal permeability and survival chances.",[91,92,26],"Multivisceral Failure Syndrome","Monovisceral Failure","RECRUITING","2025-04-29",{"date":96,"type":39},"2025-05-02",{"date":98,"type":39},"2025-02-20",{"date":100,"type":20},"2029-04-30",{"name":102,"class":46},"Direction Centrale du Service de Santé des Armées",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":113,"conditions":114,"keywords":119,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":132,"locationsCount":79},"100573684","the-gut-microbiome---source-of-sepsis-and-novel-target-in-intensive-care-units-100573684","NCT06749483","The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?","The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units? Research on Human Tissue, Body Fluids, Neuropsychological Assessment and Brain Imaging","MS-ICU","Inclusion Criteria:\n\n* Age ≥ 18 years\n* One of the following criteria\n\n  1. Critically ill patients treated with meropenem or piperacillin\u002Ftazobactam started within the last 72 h\n  2. Critically ill patients without systemic antimicrobial therapy within the last 72 hours and an expected ICU length of stay of more than 3 days\n  3. Long-term survivors of sepsis, e.g. from pre-existing sepsis cohorts\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Major bowel resection\n* Selective decontamination of the oral and digestive tract\n* Oral vancomycin therapy\n* Immunocompromised patients\n* History of chemotherapy during the last 6 months.\n* Known travel history to countries to areas of high antimicrobial resistance (\\>5% according to the report of the European Centre for Disease Prevention and Control and all countries except USA and Canada) within the last 4 weeks\n* Acute neurological diseases (e.g., brain ischemia, hemorrhage, meningoencephalitis, tumor)\n* Manifest dementia, pre-existing psychiatric diseases (schizophrenia, psychosis)\n* Acute brain surgery\n* MRI contraindications: pacemakers, hearing aids, neurostimulation, insulin pumps, other potentially ferromagnetic implants, screws, clips, prostheses, metal splinters, etc., pregnancy, claustrophobia, extensive tattoos.",{"count":112,"type":20},100,"Here, the investigators propose to study host responses to reduced microbiome complexity driven by treatment with broad spectrum antibiotics in patients with severe infections or sepsis. The proposal aims to combine holistic approaches with emerging experimental technologies to investigate the complex interactions between the gut microbiota and its host and assess the impact of specific bacterial communities on longevity and stress responses. A strong focus of this study will also be placed on microbiome dysbiosis and secondary impacts on short- and long-term brain dysfunction using clinical, laboratory and imaging procedures.",[115,116,117,118,26,27],"Critical Illness","Intensive Care Unit Delirium","Neurocognitive Deficit","Microbiome,immune Function, Critically Ill",[65,120,121,122,123,124,125],"broad-spectrum antibiotics","stool","neuropsychological assessment","delirium","neurocognitive impairment","microbiome","2024-12-27",{"date":128,"type":39},"2024-12-30",{"date":126,"type":39},{"date":131,"type":20},"2026-12-31",{"name":133,"class":46},"Jena University Hospital"]