[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613740":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":32,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":81,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Complexo Hospitalario Universitario de A Coruña","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (individualized dosing based on therapeutic monitoring)","EXPERIMENTAL","Patients will receive individualized dosing of beta-lactam antibiotics based on therapeutic monitoring. Total and free plasma concentrations will be determined 48 hours after the start of antibiotic therapy and subsequently every 4-5 days, or sooner if there is a significant clinical change. Dosage adjustments will be made to achieve the defined PK\u002FPD targets:\n\n* Standard: ≥100% fT \\> MIC.\n* Infections caused by multidrug-resistant pathogens, increased renal clearance, or immunosuppression: ≥100% fT \\> 4×MIC.\n\nConcentrations will be interpreted in relation to the actual MIC of the identified pathogen or, failing that, to the ECOFF values defined by EUCAST.",[13],"Other: Individualized dosing of beta-lactam antibiotics based on therapeutic monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (usual dosage):","NO_INTERVENTION","Patients will receive the usual dosage of beta-lactam antibiotics following the recommendations of clinical guidelines and hospital protocols, without individualized adjustment based on MDT. Plasma samples will also be collected, but will be stored for deferred analysis at the end of the study, with no impact on clinical management.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Individualized dosing of beta-lactam antibiotics based on therapeutic monitoring","In the intervention group, plasma levels will be determined 48 hours after the start of antibiotic treatment and subsequently every 4-5 days, with a pharmacotherapeutic report and dosage adjustment within \\\u003C24 hours. In the control group, samples will be stored at -80 °C and analyzed at the end of the study, with no impact on clinical practice.\n\nPlasma concentrations of beta-lactam antibiotics will be determined by high-performance liquid chromatography (HPLC) using validated commercial kits, which allow simultaneous quantification of several drugs in this group with reduced processing times and feasible implementation in hospital routine.\n\nPatients will be evaluated weekly until hospital discharge, death, or completion of antibiotic treatment. Clinical progression, inflammatory markers, emergence of resistance, adverse effects, and clinical and microbiological outcomes will be recorded.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Iria Varela Rey, Pharmacist","CONTACT","+34697538722","iriavarela13@gmail.com",{"name":31,"role":27,"phone":18,"phoneExt":18,"email":18},"Manuel A Gómez-Rios, Anesthesiologist",[33],{"facility":34,"status":18,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Clinical Hospital of Santiago de Compostela","Santiago de Compostela","A Coruña","15705","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],-8.54569,42.88052,{"lat":44,"lon":43},[47],{"name":26,"role":27,"phone":48,"phoneExt":18,"email":29},"697538722",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Manuel Ángel Gómez-Ríos","Anesthesiologist",[54],{"name":55,"class":56},"Hospital Clínico Universitario de Santiago de Compostela","UNKNOWN","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":67,"type":68},198,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74],"Bacterial Sepsis",[76,77,78,79,80],"betalactam","therapeutic drug monitoring","sepsis","clinical cure","microbiological cure","NOT_YET_RECRUITING","2025-11-23",{"date":84,"type":85},"2025-12-08","ACTUAL",{"date":87,"type":68},"2026-01-01",{"date":89,"type":68},"2029-01-01",{"name":5,"class":6},1]