[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wuhan Pulmonary Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100607690","a-study-on-the-short---course-treatment-regimen-containing-pretomanid-for-diabetes-mellitus-complicated-with-rifampicin---resistantmultidrug---resistant-pulmonary-tuberculosis-100607690",false,"NCT07191834","A Study on the Short - Course Treatment Regimen Containing Pretomanid for Diabetes Mellitus Complicated With Rifampicin - Resistant\u002FMultidrug - Resistant Pulmonary Tuberculosis","Inclusion Criteria:\n\n* Voluntary participation.\n* Aged \\>12 years, and weighing 30 kilograms or more.\n* Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an BPaL treatment regimen.\n* The diabetes group shall include patients who have been diagnosed with diabetes, either previously or currently.\n* Fertile women shall not be pregnant, voluntarily undergo a pregnancy test with a negative result, and be willing to use highly effective contraceptive measures from the time of signing the informed consent until three months after the end of the research treatment.\n* Fertile men shall use condoms or other methods to ensure effective contraception for their sexual partners.\n* Lactating women shall be willing to stop breastfeeding from the time of signing the informed consent until three months after the end of the research treatment.\n* Participants shall voluntarily undergo an HIV test. If the result is positive, they shall voluntarily accept antiretroviral therapy.\n\nExclusion Criteria:\n\n* Previously received treatment with at least one of bedaquiline (BDQ) or delamanid (DLM) for more than 28 days.\n* Currently using prohibited medications specified in the research protocol, and the researcher believes that, from the perspective of patient benefit, the priority of continuing to use the medication is higher than participating in this study.\n* Known to have had a hypersensitivity reaction to any of the medications in the protocol.\n* Currently participating in any other clinical trials of medications.\n* At the time of screening, there is a risk of cardiovascular disease: QTcF interval exceeding 480 milliseconds; a history of arrhythmia considered clinically significant by the researcher within 60 days before enrollment, and the researcher believes that participation in the study may increase the risk; decompensated heart failure; grade 3 hypertension without reaching the control target; abnormal thyroid function; abnormal levels of serum calcium, magnesium, or potassium.\n* A history of optic neuropathy or peripheral neuropathy, and the researcher believes that progression\u002Fdeterioration may occur during the study, or the participant is not suitable for the study.\n* At the time of screening, there are the following manifestations of liver diseases: active viral hepatitis; decompensated cirrhosis.\n* At the time of screening, there is a history of the following kidney diseases or manifestations related to kidney diseases: a history of unstable or rapidly progressive kidney disease; moderate\u002Fsevere renal impairment or end - stage renal disease; serum creatinine ≥133 μmol\u002FL in men and ≥124 μmol\u002FL in women.\n* Other abnormal laboratory test results: hemoglobin level \\\u003C8.0 g\u002FdL; platelet count \\\u003C75,000\u002Fmm³; absolute neutrophil count \\\u003C1000\u002Fmm³; aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\>3×ULN; total bilirubin \\>2×ULN, or \\>1.5×ULN combined with other abnormal liver enzymes; albumin \\\u003C30 g\u002FL.\n* The researcher believes that the study participant is unable to complete the study process, or participation in the study is unsafe for the study participant.","ALL","12 Years",{"count":18,"type":19},60,"ESTIMATED","48 Months","OBSERVATIONAL","The treatment of rifampicin-resistant\u002Fmultidrug-resistant pulmonary tuberculosis (RR-TB) is characterized by a long treatment course, a high incidence of adverse reactions, a low cure rate, and a high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, the high incidence of adverse reactions, and the long treatment course, which lead to poor patient compliance. There is an urgent need for new, effective, safe, and short-course anti-drug-resistant regimens. A 6-month short-course oral regimen containing pretomanid was launched in 2020 and was approved for marketing in China in March 2025. Currently, there have been multi-center studies on the treatment of rifampicin-resistant\u002Fmultidrug-resistant pulmonary tuberculosis with the pretomanid regimen initiated by investigator-initiated trials (IIT) in China, but there are no studies on special populations. The diabetic population belongs to a special population, has a relatively high incidence rate in China, and is at high risk of tuberculosis. During the treatment process, they may be more likely to experience adverse reactions and poor outcomes than ordinary patients. This study is a prospective cohort clinical study. It is planned to enroll patients aged ≥12 years with RR\u002FMTB-TB complicated by diabetes at our center. Guided by the results of rapid molecular drug susceptibility testing, both groups will be treated with a regimen consisting of bedaquiline, pretomanid, linezolid, and moxifloxacin for 6 months. The experimental group will be diabetic patients, and the control group will be non-diabetic patients. The efficacy and safety of the two groups will be evaluated to provide a basis for the treatment of a new short-course drug-resistant regimen for RR\u002FMDR-TB in special populations in China.",[24,25,26],"Rifampicin-resistant\u002FMultidrug-resistant Pulmonary Tuberculosis","Type 2 Diabetes Mellitus (T2DM)","Pretomanid",[28,29,30],"pretomanid","T2DM","RR\u002FMDR-TB","NOT_YET_RECRUITING","2025-09-21",{"date":34,"type":35},"2025-09-25","ACTUAL",{"date":37,"type":19},"2025-09-30",{"date":39,"type":19},"2027-09-30",{"name":41,"class":42},"Wuhan Pulmonary Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100608217","6-months-of-bedaquilinebdq-delamaniddlm-linezolidlzd-and-levofloxacinlfx-in-rr-tb-patients-in-hubei-province-100608217","NCT07198685","6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province","6 Months of Bedaquiline, Delamanid, Linezolid and Levoffoxacin in RR-TB Patients in Hubei Province","BDLL","Inclusion Criteria:\n\n* Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions will be included.\n* Aged between 18 and 65 years old.\n* Have never used bedaquiline, delamanid, linezolid, or levofloxacin in the past, or have used them for no more than 4 weeks.\n* Positive results of mycobacterial culture (either smear-positive or smear-negative) within the recent one month, and no effective anti-tuberculosis treatment received within this one-month period; or in the absence of recent sputum culture results, smear-positive sputum and no effective anti-tuberculosis treatment administered.\n* No history of respiratory failure or cardiac insufficiency, and no clinically significant arrhythmia manifestations on electrocardiogram.\n* During the treatment and follow - up periods, patients are required to take medications as per the research project requirements, complete treatment monitoring, and promptly report any adverse reactions to the attending physicians.\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Individuals with a history of optic neuropathy or peripheral neuropathy, whom the researchers believe may experience progression\u002Fworsening during the study or are not suitable for participation in this research.\n* Chronic active hepatitis, with positive results for three items: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti - HBc), or HBV - DNA \\> 1000 CPs\u002FmL, accompanied by elevated ALT\u002FAST. Elevation of ALT or AST is ≥3 times the upper limit of the normal value, or elevation of total bilirubin and direct bilirubin is ≥2 times the upper limit of the normal value (if it is a temporary elevation, patients can be enrolled after recovery from treatment).\n* Severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 mL\u002Fmin).\n* Individuals who have participated in clinical trials of other unlisted new drugs within the past three months.\n* Known congenital QT interval prolongation, presence of any disease that can prolong the QT interval, or a QTc \\> 450 ms.\n* Pregnant women or women who may be pregnant.\n* Any cardiac diseases capable of inducing arrhythmia, such as severe hypertension (poorly controlled blood pressure), left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure accompanied by a reduced left ventricular ejection fraction.\n* A history of known, untreated, and persistent hypothyroidism. Combined with hematogenous disseminated tuberculosis and central nervous system tuberculosis.\n* A history of allergy or a known allergy to any investigational medicinal product or related substances.\n* HIV-positive.","18 Years","65 Years",{"count":54,"type":19},52,"INTERVENTIONAL",[57],"NA","This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen within the Chinese population. The main questions it aims to answer are:\n\nIs the efficacy of short regimen non-inferior to standard regimen? Is the short regimen safe enough to replace the standard regimen?\n\nParticipants will:\n\nBe given with either short or standard regimen for RR-TB treatment Be asked to complete the scheduled visit as planned.",[60,61],"Treat to Target","Treatment Duration",[49,30],{"date":37,"type":35},{"date":37,"type":19},{"date":66,"type":19},"2028-09-30",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":55,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":4},"100602678","a-study-on-the-short-course-treatment-regimen-containing-pretomanid-for-drug-resistant-tuberculosis-100602678","NCT07126639","A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis","BPaLM","Inclusion Criteria:\n\nhe research participants themselves voluntarily signed the informed consent form before being enrolled; for those without full capacity for civil conduct, the consent form was signed by their legal guardians.\n\nThe research participants (and their guardians) indicated their willingness to complete all steps and intervention periods of the study.\n\nMale or female, aged 12 years or older, weighing 30 kilograms or more. Confirmed cases of pulmonary tuberculosis pathogen, with molecular or phenotypic drug sensitivity results within the past 3 months confirming resistance to rifampicin, and confirmed by the pathogen culture results of sputum collected at the time of enrollment.\n\nFertile women not in pregnancy, voluntarily undergoing pregnancy tests, with negative results, and willing to use highly effective contraceptive measures from the time of signing the informed consent until 3 months after the end of the study treatment.\n\nFor fertile men, use condoms or other methods to ensure effective contraception for their sexual partners.\n\nWomen in lactation, willing to stop breastfeeding from the time of signing the informed consent until 3 months after the end of the study treatment.\n\nVoluntary to undergo HIV testing. If the result is positive, voluntarily accept antiretroviral therapy.\n\nExclusion Criteria:\n\nHad a known hypersensitivity reaction to any drug in the protocol. Was participating in any clinical trial of other drugs. At the screening stage, had cardiovascular disease risk: QTcF interval over 480 milliseconds; within 60 days before enrollment, had a history of clinically significant arrhythmia that the investigator considered could be clinically significant, and the investigator considered that participating in the study might increase the risk; decompensated heart failure; grade 3 hypertension and not reaching the control target; thyroid dysfunction; abnormal serum calcium, magnesium or potassium levels.\n\nHad a history of optic nerve or peripheral nerve lesion, and the investigator considered that it might progress\u002Fdeteriorate during the study or was not suitable for participating in this study.\n\nAt the screening stage, had the following liver disease manifestations: active viral hepatitis; decompensated stage of liver cirrhosis.\n\nAt the screening stage, had the following kidney disease history or kidney-related manifestations: unstable or rapidly progressive kidney disease history; moderate\u002Fsevere renal function impairment or end-stage renal disease; male serum creatinine ≥ 133 μmol\u002FL, female serum creatinine ≥ 124 μmol\u002FL.\n\nOther laboratory test abnormalities: hemoglobin level \\\u003C 8.0 g\u002FdL; platelet count \\\u003C 75,000\u002Fmm³; absolute neutrophil count \\\u003C 1000\u002Fmm³; aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\> 3×ULN; total bilirubin \\> 2×ULN, or \\> 1.5×ULN, combined with other liver enzyme abnormalities; albumin \\\u003C 30 g\u002FL.\n\nThe investigator considered that the study participants could not complete the study process, or participating in the study was unsafe for the study participants.",{"count":76,"type":19},200,[57],"Rifampicin-resistant tuberculosis (RR-TB) is characterized by a long treatment course, high incidence of adverse reactions, low cure rate and high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, high incidence of adverse reactions and long treatment course, which leads to poor patient compliance. There is an urgent need for new, effective and safe short-course regimens for drug-resistant tuberculosis. A 6-month short-course oral regimen containing pretomanid was introduced in 2020. However, as pretomanid is not yet available in China, it has not been verified and promoted in China. Pretomanid is expected to be launched in China in 2025, and it is urgent to evaluate the application of the new short-course regimen containing pretomanid in the Chinese population. This study is a prospective, randomized, controlled clinical trial. It plans to include RR-TB patients aged ≥12 years in multiple domestic centers. Under the guidance of rapid molecular drug susceptibility test results, the experimental group will be treated with bedaquiline, pretomanid, linezolid and moxifloxacin for 6 months, while the control group will be treated with bedaquiline, delamanid, linezolid and levofloxacin or bedaquiline, delamanid, linezolid and clofazimine for 6 months, depending on the susceptibility to fluoroquinolones. For patients with unknown susceptibility to fluoroquinolones, bedaquiline, delamanid, linezolid, levofloxacin and clofazimine will be used for 6 months. The efficacy and safety will be evaluated to provide a basis for the introduction and implementation of new short-course regimens for RR-TB in China.",[80],"Efficacy and Safety",[73,82],"short-course treatment regiment","2025-08-10",{"date":85,"type":35},"2025-08-17",{"date":87,"type":19},"2025-09-01",{"date":66,"type":19},{"name":41,"class":42},""]