[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629626":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":42,"responsibleParty":57,"collaborators":60,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":12,"enrollmentInfo":76,"targetDuration":12,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":45,"whyStopped":12,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"ASST Fatebenefratelli Sacco","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: linezolid 600 mg standard dose. Only TDM monitoring","NO_INTERVENTION","Linezolid will be administered at the recommended dose of 600 mg. The linezolid level will be measured for each patient once a week during the first month (4 blood samples), then once a month for the following 5 months (5 blood samples) to complete the 6-month regimen (at least 9 blood samples for each patient). One additional sample will be taken if linezolid-related side effects appear. No changes to the linezolid dosage will be made except as directed in accordance with the national guidelines for the management of MDR-TB.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Group B: linezolid dose personalization based on TDM","EXPERIMENTAL","Linezolid will be initially administered at the recommended dose of 600 mg. The linezolid level will be measured for each patient once a week during the first month (4 blood samples), then once a month for the following 5 months (5 blood samples) to complete the 6-month regimen (at least 9 blood samples for each patient). Additional samples will be taken if linezolid-related side effects appear or if the trough linezolid concentration in the blood does not reach the reference range of 0.6-2 mg\u002Fl. The dosage of linezolid will be modified according to the TDM",[18],"Drug: Linezolid dose personalization based on TDM",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Linezolid dose personalization based on TDM","The dosage of linezolid will be modified according to the TDM as follows: if \\> 2 mg\u002Fl the dosage will be decreased by 300 mg (minimum 300 mg every second day, TDM repeated after one week); if \\\u003C 0.6 mg\u002Fl the dosage will be increased by 300 mg (maximum 1200 mg, TDM repeated after one week); if between 0.6 and 2 mg\u002Fl the dosage will not be changed (regular TDM timepoints)",[14],[26,30],{"name":27,"affiliation":28,"role":29},"Marco Schiuma","ASST Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy","STUDY_DIRECTOR",{"name":31,"affiliation":32,"role":33},"Souleymane Hassane Harouna","Action Daminen Guinée","PRINCIPAL_INVESTIGATOR",[35,39],{"name":27,"role":36,"phone":37,"phoneExt":12,"email":38},"CONTACT","+393284931986","schiuma.marco@asst-fbf-sacco.it",{"name":31,"role":36,"phone":40,"phoneExt":12,"email":41},"+224620717593","hassoul20@yahoo.fr",[43],{"facility":44,"status":45,"city":46,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Centre de Santé de Tombolia","RECRUITING","Conakry","Guinea","GN",{"type":50,"coordinates":51},"Point",[52,53],-13.67729,9.53795,{"lat":53,"lon":52},[56],{"name":31,"role":36,"phone":40,"phoneExt":12,"email":41},{"type":58,"investigatorFullName":27,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Medical Doctor, Infectious Diseases Specialist",[61,62,64],{"name":5,"class":6},{"name":63,"class":6},"University of Milan",{"name":65,"class":6},"Damien Foundation","100629626","phase-4-linezolid-tolerance-during-the-bpal-regimen-with-dosage-personalization-based-on-therapeutic-drug-monitoring-tdm-during-multidrug-resistant-tuberculosis-treatment-100629626",false,"NCT07477119","Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment","Tolérance du Linézolide Pendant le Régime BPaL Avec Personnalisation de la Posologie Basée Sur la Surveillance Thérapeutique Des Médicaments (TDM) au Cours du Traitement de la Tuberculose Multirésistante","PLOT-TB","Inclusion Criteria:\n\n* 1\\. Confirmed diagnosis of MDR-TB\n* 2\\. Linezolid prescribed as part of the BPaL\u002FBPaL-M regimen\n* 3\\. Age 15 years or older\n* 4\\. Informed consent obtained from the participant or assent from the parent\u002Flegal guardian for participants under 18 years of age.\n\nExclusion Criteria:\n\n* 1\\. Pregnancy or breastfeeding\n* 2\\. Severe liver or kidney failure\n* 3\\. Known hypersensitivity to linezolid\n* 4\\. Concomitant use of medications with drug interactions potential with linezolid","ALL","15 Years",{"count":77,"type":78},150,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health.\n\nGlobally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023. Only 44% were diagnosed and put on treatment, the therapeutic success rate of the 2021 cohort is only 68%.\n\nIn Guinea, the number of patients with MDR-TB is estimated at 450, and the treatment success rate is 74% for the 2021 cohort, primarily with the 9-months short oral regimen.\n\nSince 2022, the WHO has recommended the use of the 6-month short course of BPaL\u002FBPaL-M for national tuberculosis control programs and Guinea began implementing this new regime within the programmatic framework starting in January 2025.\n\nLinezolid, a key component of new therapeutic regimens such as BPaL\u002FBPaL-M, shows high bactericidal activity, although it is associated with serious adverse effects in a high percentage of patients, including myelosuppression, neuropathy and, in some cases, fatal lactic acidosis. In particular, peripheral neuropathy, an adverse event often irreversible that may lead to linezolid and the BPaL\u002FBPaL-M regimen discontinuation, is reported in approximately 24% of patients receiving linezolid at 600 mg.\n\nA linezolid blood trough level of above 2 mg\u002Fl is associated with side effects, but its pharmacokinetics varies considerably between individuals and over time.\n\nThere is little data on the role of therapeutic drug monitoring (TDM) in guiding its administration, some studies showing how the standard dose of 600 mg could exceed the toxicity target and the reduced dose of 300 mg might not achieve the target efficacy.\n\nThe main objective of this study is to determine the role of TDM in the optimization of linezolid dosage in TB-MDR patients treated with the BPaL\u002FBPaL-M regimen.\n\nThe specific objectives aim to evaluate:\n\n* the variation in the occurrence of adverse events between patients who undergo a modification of the linezolid dose based on the TDM and patients taking linezolid standard dose\n* the treatment outcome in patients who undergo a modification of the linezolid dose based on TDM and patients taking linezolid standard dose\n* variations in the distribution of TDM throughout treatment in order to identify potential common trends.",[84,85,86],"Linezolid","Tuberculosis Multi Drug Resistant Active","Therapeutic Drug Monitoring (TDM)",[88,89,90,91,47,92,93,94,95],"linezolid","TDM","Therapeutic Drug Monitoring","MDR-TB","Adverse Drug Reaction","Peripheral Neuropathy","Myelosuppression","Tuberculosis","2026-05-11",{"date":98,"type":99},"2026-05-13","ACTUAL",{"date":101,"type":78},"2026-04",{"date":103,"type":78},"2028-04",{"name":27,"class":6},1]