[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561069":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":22,"locations":32,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":10,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Pulmonary tuberculosis",null,[12],"Other: MIPD",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":10},"MIPD","This is a non-inverventional study",[9],[19],{"name":20,"affiliation":5,"role":21},"Lina Davies Forsman, MD, PhD","PRINCIPAL_INVESTIGATOR",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Lina Davies Forsman, MD, PhD, Associate Professor","CONTACT","08-12370000","lina.davies.forsman@ki.se",{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},"Katarina Niward, MD, PhD","+46 10 103 00 00","katarina.niward@liu.se",[33,51],{"facility":34,"status":35,"city":36,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Linköping University Hospital","RECRUITING","Linköping","Sweden","SE",{"type":40,"coordinates":41},"Point",[42,43],15.62157,58.41086,{"lat":43,"lon":42},[46,49],{"name":47,"role":25,"phone":10,"phoneExt":48,"email":31},"Katarina Niward Senior Consultant, PhD, MD","+46 10 103 00",{"name":50,"role":21,"phone":10,"phoneExt":10,"email":10},"Katarina Niward, PhD",{"facility":52,"status":35,"city":53,"state":10,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Karolinska University Hospital","Stockholm","17177",{"type":40,"coordinates":56},[57,58],18.06871,59.32938,{"lat":58,"lon":57},[61,64,65],{"name":62,"role":25,"phone":63,"phoneExt":10,"email":27},"Lina Davies Forsman Senior Consultant, Ass. Professor, PhD, MD","+ 46 8 123 70 000",{"name":10,"role":25,"phone":10,"phoneExt":10,"email":27},{"name":66,"role":21,"phone":10,"phoneExt":10,"email":10},"Lina Davies Forsman",{"type":21,"investigatorFullName":66,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Principal Investigator",[70,71],{"name":52,"class":6},{"name":72,"class":6},"Region Östergötland","100561069","dosetb-individualised-dosing-by-model-informed-precision-dosing-for-pulmonary-tuberculosis-100561069",false,"NCT06585358","DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis","DoseTB","Inclusion criteria\n\n1. Adult persons ≥18 years with confirmed pulmonary TB (established through Mtb cultures or PCR for Mtb by clinical routine)\n2. Ongoing or planned treatment of TB that includes rifampin\n3. Written informed consent\n\nExclusion criteria\n\n1. TB treatment with rifampin for longer than 8 weeks prior to inclusion\n2. TB treatment with intravenous rifampin (including patients treated at an intensive care unit (ICU) or patients with cerebral TB)\n3. TDM of rifampin has already been performed (\\>24 h before inclusion) by clinical routine\n4. Study participants with extrapulmonary TB without pulmonary TB.","ALL","18 Years",{"count":83,"type":84},30,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to investigate whether model-informed precision dosing (MIPD), as a clinical support for early individualised dosing in addition to the national TB care program, can optimise the drug exposure of TB drugs during TB treatment.\n\nMain research questions:\n\nIn adult patients with drug-susceptible pulmonary tuberculosis, can current dose recommendations and information received from MIPD help clinicians in a timely manner to optimise the drug exposure of TB drugs in the early treatment phase, i.e., the time from PK sampling to dose adjustment (keep or adjust dose)?\n\nSpecific aims\n\nI. To perform a process evaluation of early MIPD for rifampicin, isoniazid, pyrazinamide and ethambutol during active TB treatment.\n\nII. To study the target attainment of first-line TB drugs with MIPD.\n\nIII. To evaluate model precision of predicted versus detected drug concentrations.\n\nDrug concentrations will be measured in study participants during TB treatment, and drug exposure and the optimal dose will be predicted by MIPD using pharmacokinetic population models.",[88],"Tuberculosis, Pulmonary",[90,91],"model-informed precision dosing","individualised dosing","2025-11-18",{"date":94,"type":95},"2025-11-21","ACTUAL",{"date":97,"type":95},"2025-11-01",{"date":99,"type":84},"2027-12",{"name":5,"class":6},2]