[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474165":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":40,"locations":40,"responsibleParty":69,"collaborators":40,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":40,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":40,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":40,"overallStatus":92,"whyStopped":40,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":40},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,17,22,29],{"label":9,"type":10,"description":11,"interventionNames":12},"The three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin-containing regimen","EXPERIMENTAL","Thirteen weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin.",[13,14,15,16],"Drug: Sitafloxacin","Drug: Pyrazinamide","Drug: Rifapentine","Drug: Isoniazid",{"label":18,"type":10,"description":19,"interventionNames":20},"The three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin&SMZ\u002FTMP-containing regimen","Six weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ\u002FTMP and Sitafloxacin.",[13,21,14,15,16],"Drug: SMZ\u002FTMP",{"label":23,"type":24,"description":25,"interventionNames":26},"The six-month standard Rifampin&Isoniazid&Pyrazinamide&Ethambutol-containing regimen","ACTIVE_COMPARATOR","Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid.",[27,14,16,28],"Drug: Rifampin","Drug: Ethambutol",{"label":30,"type":24,"description":31,"interventionNames":32},"The four-month Rifapentine&Isoniazid&Pyrazinamide&Moxifloxacin -containing regimen","Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.",[15,16,28,33],"Drug: Moxifloxacin",[35,41,45,49,53,57,61,65],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Sitafloxacin","In our Intervention group, sitafloxacin replace the ethambutol, 200mg\u002Fd",[18,9],null,{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"SMZ\u002FTMP","In our The three-month Rifapentine\\&Isoniazid\\&Pyrazinamide\\&Sitafloxacin\\&SMZ\u002FTMP-containing regimen, Six weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ\u002FTMP and Sitafloxacin, SMZ 80mg\u002Fkg\u002Fd, TMP16mg\u002Fkg\u002Fd",[18],{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":40},"Rifampin","Rifampin is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, Rifampin 600mg (8-12mg\u002Fkg\u002Fd)",[23],{"type":36,"name":50,"description":51,"armGroupLabels":52,"otherNames":40},"Pyrazinamide","Pyrazinamide is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 2000mg (20-30mg\u002Fkg\u002Fd)",[23,18,9],{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"Rifapentine","In our Intervention group, rifapentine replace rifampin, 600mg\u002Fd",[30,18,9],{"type":36,"name":58,"description":59,"armGroupLabels":60,"otherNames":40},"Isoniazid","Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg\u002Fkg\u002Fd)",[30,23,18,9],{"type":36,"name":62,"description":63,"armGroupLabels":64,"otherNames":40},"Ethambutol","Ethambutol is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 1200mg (15-25mg\u002Fkg\u002Fd)",[30,23],{"type":36,"name":66,"description":67,"armGroupLabels":68,"otherNames":40},"Moxifloxacin","Moxifloxacin is a fourth-generation fluoroquinolone with potent activity against M. tuberculosis in vitro and in vivo, 400mg (7.5-10mg\u002Fkg\u002Fd)",[30],{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Zhang Ying","Prof, MD","100474165","phase-3-sitafloxacin-containing-regimens-for-shortening-tuberculosis-treatment-100474165",false,"NCT05454345","Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment","A Randomized Controlled Non-Inferiority Study for Shortening Tuberculosis Treatment With Sitafloxacin-Containing Regimens","Inclusion Criteria:\n\n1. Age 18 years to 70.\n2. At least one sputum specimen is positive for acid-fast bacilli or positive results of sputum culture on smear microscopy(species identification as M. tuberculosis) or at least one sputum specimen positive for M. tuberculosis by Xpert MTB\u002FRIF testing.\n3. Phenotypic drug susceptibility testing indicates the patient's isolate is susceptible to rifampin, isoniazid, pyrazinamide, ethambutol, rifapentine, moxifloxacin, and Sitafloxacin.\n4. Patients have written informed consent.\n\nExclusion Criteria:\n\n1. Extra-pulmonary or Disseminated TB.\n2. HIV-positive individuals, steroid-dependent and those on steroid treatment.\n3. Autoimmune diseases, severe hepatic or renal dysfunction, psychosis, hematological malignancies, cancer, diabetes individuals.\n4. Known allergy to one or more of the study drugs.\n5. Women who are currently pregnant or breast-feeding.\n6. Patients who received any investigational drug in the past three months.\n7. The patients refused treatment with medications\n8. Mycobacterium tuberculosis\u002Fnontuberculous mycobacterium co-infection.\n9. In the investigator's judgment, other medical conditions that are not in the individual's best interest to participate.","ALL","18 Years","70 Years",{"count":84,"type":85},620,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","This study is a clinical trial conducted to determine whether the sitafloxacin-containing three-month regimens are as effective as the standard six-month regimen and the four-month rifapentine and moxifloxacin regimen (substitution of rifapentine for rifampin and moxifloxacin for ethambutol) for treatment of pulmonary tuberculosis. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide, followed by four months of isoniazid and rifampin. The four-month regimen consists of two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid rifapentine and moxifloxacin. The new three-month tuberculosis treatment regimens are six weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide, followed by seven weeks of isoniazid, rifapentine, and Sitafloxacin, or 13 weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide. The primary research question is to evaluate the efficacy and safety of the 3 month Sitafloxacin-containing regimen, and to determine if it can shorten the treatment of drug-susceptible pulmonary tuberculosis while achieving non-inferiority in treatment success with the current 6 month and 4 month treatment regimens. Safety, side effects of Sitafloxacin for participants in the clinical trial are also assessed. Rates of cure, treatment success, recurrence, and cure (cure without recurrence) are determined for subgroup analysis in the standard six-month regimen group, the four-month regimen group, and two three-month regimen groups.",[91],"Tuberculosis, Pulmonary","NOT_YET_RECRUITING","2022-07-07",{"date":95,"type":96},"2022-07-12","ACTUAL",{"date":98,"type":85},"2022-10-01",{"date":100,"type":85},"2026-06-30",{"name":5,"class":6}]