[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480343":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":67,"collaborators":30,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":30,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":53,"whyStopped":30,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Tedizolid arm","EXPERIMENTAL","Patients will be taken 1 tablet per day of 200 mg film-coated of Tedizolid (SIVEXTRO®), in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms.",[13],"Drug: Tedizolid arm (SIVEXTRO®)",{"label":15,"type":10,"description":16,"interventionNames":17},"Linezolid arm","Patients will be taken 2 tablets per day of 600 mg film-coated of Linezolid (ZYVOXID®) in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms.",[18],"Drug: Linezolid arm (ZYVOXID®)",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard quadruple therapy arm","ACTIVE_COMPARATOR","Patients will be taken :\n\nISONIAZIDE :\n\no A dosage of 3 to 5mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach) of Isoniazid (RIMIFON®)\n\nRIFAMPICINE :\n\no A dosage of 10mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach)\n\nETHAMBUTOL :\n\no A dosage of 15-20mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach) of Ethambutol\n\nPYRAZAMIDE :\n\no A dosage of 20-25mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach) of Pyrazinamide\n\nThen, the early bactericidal activity will be measured and compared to the other arms.",[24],"Drug: Standard quadruple therapy arm",[26,31,34],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"DRUG","Tedizolid arm (SIVEXTRO®)",[9],null,{"type":27,"name":32,"description":16,"armGroupLabels":33,"otherNames":30},"Linezolid arm (ZYVOXID®)",[15],{"type":27,"name":20,"description":35,"armGroupLabels":36,"otherNames":30},"Patients will be taken :\n\nISONIAZIDE :\n\no A dosage of 5mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach) of Isoniazid (RIMIFON®)\n\nRIFAMPICINE :\n\no A dosage of 10mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach)\n\nETHAMBUTOL :\n\no A dosage of 15-20mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach) of Ethambutol\n\nPYRAZAMIDE :\n\no A dosage of 20-25mg \u002F kg \u002F day for 7 days (to be taken in the morning on an empty stomach) of Pyrazinamide\n\nThen, the early bactericidal activity will be measured and compared to the other arms.",[20],[38],{"name":39,"affiliation":5,"role":40},"Nicolas VEZIRIS, PU-PH","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},"CONTACT","01 49 28 30 41","nicolas.veziris@aphp.fr",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"Ruxandra CALIN, MD","01 56 01 74 12","ruxandra.calin@aphp.fr",[51],{"facility":52,"status":53,"city":54,"state":30,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Bacteriology department- Hôpital Saint-Antoine","RECRUITING","Paris","75012","France","FR",{"type":59,"coordinates":60},"Point",[61,62],2.3488,48.85341,{"lat":62,"lon":61},[65,66],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100480343","phase-2-evaluation-of-the-early-bactericidal-activity-of-tedizolid-and-linezolide-against-mycobacterium-tuberculosis-teditub-100480343",false,"NCT05534750","Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)","Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis","TEDITUB","Inclusion Criteria:\n\n* Age ≥ 18 years old and \\\u003C75 years old\n* Woman on childbearing age should be on effective contraception during the duration of the study and up to 6 months after treatment; a mechanical contraception (use of condom) will be strongly recommended\n* Male (effective contraception must be used during duration of the study and up to 3 months after treatment)\n* Patient with a first infection with Mycobacterium tuberculosis of pulmonary localization suspected by the presence of a clinical pulmonary symptomatology, a chest X-ray or an abnormal chest computed tomography, and the positive microscopic examination of a sputum (AFB +, presence of AFB) with confirmation of tuberculosis by a genotypic test demonstrating no resistance to rifampicin, without clinical signs of extra-thoracic involvement\n* State medical assistance application being processed ( If patient does not benefit from social security),\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Resistance to one of the anti-tuberculosis drugs used detected by a genotypic test in accordance with the recommendations of the High Council of Public Health of 2015;\n* History of anti-tuberculosis treatment (patients with a documented negative genotypic test for isoniazid and rifampicin resistance may be included)\n* History of treatment in the previous two years with one of the antibiotics evaluated in this trial lasting more than one month;\n* Absolute contraindication to the use of at least one of the test molecules (isoniazid, rifampicin, ethambutol, pyrazinamide, linezolid, tedizolid);\n* Tuberculosis having, in the opinion of the investigator, severity criteria not allowing to wait 7 days before starting standard treatment (oxygenorequirement, severe immunosuppression, extra-pulmonary involvement, any sign of severity requiring treatment in intensive care unit);\n* HIV-infected patient receiving protease inhibitors whose antiviral treatment cannot be changed and therefore cannot receive rifampicin; or any other drug contraindicated with one of the study treatments (the list of contraindicated drugs is detailed in the following non-inclusion criteria).\n* Neoplastic pathology during treatment with chemo and \u002F or radiotherapy;\n* Decompensated cirrhosis;\n* Pregnancy, desire to become pregnant, breast-feeding (for women of childbearing potential, contraception should be used for the duration of the study and up to 6 months after treatment, mechanical contraception will be strongly recommended and up to 3 months after treatment);\n* Protected adults (under guardianship, curatorship) and under safeguard of justice\n* Significant laboratory abnormalities (hemoglobin \\\u003C9g \u002F dl, polynuclear neutrophils \\\u003C500 \u002F mm3, platelets \\\u003C50,000 \u002F mm3, creatinine clearance \\\u003C30ml \u002F min, ASAT or ALAT\\> 3N, and total bilirubin\\> 3N)\n* Hyperuricaemia\n* Porphyria\n* Optic neuritis or peripheral neuropathy\n* BMI≤ 16 kg\u002Fm2\n* Participation in other interventional research\n* Current treatment with one or more medications contraindicated in combination with linezolid: Linezolid should not be used in patients treated with monoamine oxidase A or B inhibitors (for example: phenelzine, isocarboxacid, selegiline, moclobemide) or who received one of these products in the previous two weeks\n* Current treatment with one or more medications contraindicated in combination with quadritherapy:\n* Combination with bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir\u002Felbasvir, protease inhibitors boosted by ritonavir, isavuconazole, ledipasvir, lurasidone, midostaurin, ombitasvir\u002Fparitaprevir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprevir\n* Gastrointestinal topicals, antacids and adsorbents and salts and aluminum hydroxides","ALL","18 Years","75 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).",[88,89],"Tuberculosis","Multidrug Resistant Tuberculosis",[88,91,92,93,94,95,96,97,98],"Multidrug Resistant","Linezolid","Tedizolid","Pyrazinamide","Rifampicin","Isionazid","Ethambutol","Early Bactericidal Activity","2025-01-31",{"date":101,"type":102},"2025-02-03","ACTUAL",{"date":104,"type":102},"2023-04-20",{"date":106,"type":82},"2026-05",{"name":5,"class":6},1]