[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"therapeutic-drug-monitoring-tdm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:therapeutic-drug-monitoring-tdm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Linezolid","Tuberculosis Multi Drug Resistant Active","Therapeutic Drug Monitoring (TDM)",[31,32,33,34,35,36,37,38,39],"linezolid","TDM","Therapeutic Drug Monitoring","MDR-TB","Guinea","Adverse Drug Reaction","Peripheral Neuropathy","Myelosuppression","Tuberculosis","RECRUITING","2026-05-11",{"date":43,"type":44},"2026-05-13","ACTUAL",{"date":46,"type":21},"2026-04",{"date":48,"type":21},"2028-04",{"name":50,"class":51},"Marco Schiuma","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":65,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":52},"100612895","escitalopram-plasma-concentrations-in-premenopausal-and-postmenopausal-women-100612895","NCT07259525","Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women","MENO-ES","Inclusion Criteria:\n\n* Aged 40 years or older and 60 years or younger\n* Diagnosed with major depressive disorder and\u002For generalized anxiety disorder by an independent psychiatrist (not a member of the research team)\n* Prescribed escitalopram treatment by an independent psychiatrist (not a member of the research team)\n* Receiving escitalopram treatment for at least one month and on a stable dose for at least one week\n* Willing to participate in the study and provide informed consent\n* Additional inclusion criterion for the menopausal group: Amenorrhea for at least one year (consistent with menopause diagnosis)\n* Additional inclusion criteria for the premenopausal group: Having regular menstrual cycles and being in the luteal phase (within 14 days after ovulation) of the menstrual cycle\n\nExclusion Criteria:\n\n* Diagnosis of intellectual disability, dementia, psychotic disorders, schizoaffective disorder, or bipolar disorder\n* Alcohol or substance use disorder\n* Diagnosis of hepatic failure, renal failure, or cardiac failure\n* Severe malnutrition\n* Presence of an active systemic infectious or inflammatory disease\n* Current use of hormone replacement therapy for menopause\n* Use of oral contraceptives\n* Pregnancy or breastfeeding\n* Use of medications known to affect escitalopram plasma concentration\n* Use of medications that affect the CYP2C19 enzyme\n* Detection of alleles other than the predominant CYP2C19\\*1 genotype in genetic analyses","FEMALE","40 Years","60 Years",{"count":64,"type":21},94,"14 Days","OBSERVATIONAL","This observational cross-sectional case-control study aims to evaluate the effects of menopausal status on escitalopram metabolism in women. The study will include premenopausal and menopausal women aged 40-60 years who are currently receiving escitalopram treatment and have applied to the Psychiatry Clinic of Eskişehir Osmangazi University. The study aims to identify pharmacokinetic differences associated with hormonal status and to investigate their potential clinical implications. Findings from this research are expected to contribute to the development of evidence-based, individualized treatment strategies for women in menopausal transition.",[29,69,70,71],"Menopause","Depression - Major Depressive Disorder","General Anxiety Disorder",[73,74,75,76,77,78],"escitalopram","desmethylescitalopram","menopause","therapeutic drug monitoring","major depressive disorder","general anxiety disorder","NOT_YET_RECRUITING","2025-12-16",{"date":82,"type":44},"2025-12-22",{"date":84,"type":21},"2026-01",{"date":86,"type":21},"2028-06",{"name":88,"class":51},"Eskisehir Osmangazi University"]