[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587539":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":48,"responsibleParty":65,"collaborators":46,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":46,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":95,"whyStopped":46,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care beta-lactam treatment","ACTIVE_COMPARATOR","Beta-lactam standard-of-care dosing regimen, as currently used at participating wards, during 28 day study period",[13],"Drug: Beta-lactam antibiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Beta-lactam model-informed precision dosing","EXPERIMENTAL","fT\\>MIC-based model-informed precision dosing of beta-lactam antibiotics using a dosing calculator during 28 day study period.",[13,19],"Device: Beta-lactam model-informed precision dosing",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Beta-lactam antibiotic","amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment",[15,9],[27,28,29],"amoxicillin-clavulanic acid","piperacillin-tazobactam","meropenem",{"type":31,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","A dosing calculator is used for the prediction of starting doses (a priori dose predictions) and follow-up doses (a posteriori calculations), using a target 100% fT\\>MIC.",[15],[35],"Dosing calculator",[37],{"name":38,"affiliation":39,"role":40},"Evelyn Dhont, Dr.","Ghent University Hospital, Princess Elisabeth Children's Hospital","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Pieter De Cock, Prof.","CONTACT","+32 9 332 29 69",null,"pieter.decock@uzgent.be",[49],{"facility":50,"status":46,"city":51,"state":46,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ghent University Hospital","Ghent","9000","Belgium","BE",{"type":56,"coordinates":57},"Point",[58,59],3.71667,51.05,{"lat":59,"lon":58},[62,63],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},{"name":64,"role":40,"phone":46,"phoneExt":46,"email":46},"Evelyn Dhont",{"type":66,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100587539","phase-4-precision-dosing-of-beta-lactam-antibiotics-in-critically-ill-children-100587539",false,"NCT06929702","Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children","Early Model-Informed Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children: Big Solution for Small People?","MOMENTUM","Inclusion Criteria:\n\n* Subject aged between 0 - 17 years 10 months.\n* Subject admitted to a participating ward unit (Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Hematology-Oncology unit).\n* Strongly suspected or confirmed systemic infection.\n* Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is\n* 40 hours for amoxicillin-clavulanic acid (based on elimination half-life)\n* 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life) Subject planned to start on intravenous amoxicillin (without clavulanic acid) will not be included.\n* Informed consent\u002Fassent signed by parents or legal representatives of the subject.\n* Not previously enrolled in this trial.\n\nExclusion Criteria:\n\n* Subject with serum creatinine level ≥ 2 mg\u002FL at inclusion.\n* Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique.\n* Subject receiving (or planned to receive) body cooling.\n* Subject death is deemed imminent and inevitable.\n* Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours (\\*) after start treatment.\n* The subject is known or suspected to be pregnant.\n* The subject has a known allergy to the specific beta-lactam antibiotic.\n\n(\\*) The first (a posteriori) dose calculation and dose adjustment if necessary, is performed within a maximum timeframe of 28 hours after start of treatment (i.e. maximum timeframe to first dose adjustment).","ALL","0 Years","18 Years",{"count":79,"type":80},58,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.",[86,87,88],"Amoxicillin-clavulanate","Piperacillin-tazobactam","Meropenem",[90,91,29,92,93,94],"amoxicillin-clavulanate","piperacillint-tazobactam","model-informed precision dosing","dose calculator","critically ill children","NOT_YET_RECRUITING","2025-04-08",{"date":98,"type":99},"2025-04-16","ACTUAL",{"date":101,"type":80},"2025-04-22",{"date":103,"type":80},"2027-10-01",{"name":5,"class":6},1]