[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Complexo Hospitalario Universitario de A Coruña\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100613740","therapeutic-monitoring-of-beta-lactams-in-critically-ill-patients-with-sepsis-100613740",false,"NCT07270523","Therapeutic Monitoring of Beta-lactams in Critically Ill Patients With Sepsis","Therapeutic Monitoring of Beta-lactams in Critically Ill Patients With Sepsis: OPTIBETA Clinical Trial Protocol","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of sepsis according to Sepsis-3 (SOFA ≥2).\n* Initiation of treatment with beta-lactam antibiotics.\n* Informed consent signed by the patient or their legal representative within the first 48 hours after the start of antibiotic therapy.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to beta-lactams.\n* Discontinuation of antibiotic treatment before the first TDM determination.\n* Simultaneous participation in another clinical trial.","ALL","18 Years",{"count":19,"type":20},198,"ESTIMATED","INTERVENTIONAL",[23],"NA","Background: Sepsis is a leading cause of morbidity and mortality among critically ill patients and is associated with intensive use of β-lactam antibiotics. These drugs show time-dependent pharmacodynamics and high pharmacokinetic variability in this population, making it difficult to achieve therapeutic levels. Therapeutic drug monitoring (TDM) may optimize dosing, but its routine clinical implementation remains limited.\n\nObjective: To evaluate whether individualized β-lactam dosing guided by TDM reduces time to full clinical recovery compared with standard dosing in critically ill patients with sepsis.\n\nMethods: OPTIBETA is a pragmatic, randomized, controlled, open-label clinical trial to be conducted at a tertiary hospital in Spain. Adult patients (≥18 years) admitted to the intensive care unit or infectious diseases ward with sepsis will be included. Participants will be randomized 1:1 to either a TDM-guided dosing arm (dose adjustments according to PK\u002FPD targets) or a standard dosing arm. Clinical, microbiological, and pharmacological outcomes will be collected. The primary endpoint is time to complete clinical cure. Secondary outcomes include overall survival, microbiological cure, ICU and hospital length of stay, adverse events, and achievement of PK\u002FPD targets. The estimated sample size is 198 patients.\n\nExpected results: We hypothesize that TDM-guided dosing will reduce time to clinical cure, improve overall outcomes, and decrease adverse events compared with standard dosing.\n\nConclusions: OPTIBETA will provide high-quality evidence on the role of β-lactam TDM in critically ill septic patients and may support its inclusion in antimicrobial stewardship programs.",[26],"Bacterial Sepsis",[28,29,30,31,32],"betalactam","therapeutic drug monitoring","sepsis","clinical cure","microbiological cure","NOT_YET_RECRUITING","2025-11-23",{"date":36,"type":37},"2025-12-08","ACTUAL",{"date":39,"type":20},"2026-01-01",{"date":41,"type":20},"2029-01-01",{"name":43,"class":44},"Complexo Hospitalario Universitario de A Coruña","OTHER",""]