2024-519983-42-00招募中2 期
Safety of Rifampicin at High Dose for the Treatment of Adult Subjects with Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2025年2月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- proportion of participants with one or more SAE (i.e. grade 3 or 4 AE) at 8 weeks of treatment
研究概览
简要总结
To evaluate the safety of high-dose rifampicin (35 mg/kg/d) supplemented with standard doses of isoniazid, pyrazinamide, and ethambutol for 8 weeks in adult subjects with pulmonary or extrapulmonary DS-TB belonging to difficult to treat subgroups. • Safety will be defined based on the proportion of participants experiencing severe adverse events (grade 3 or superior according to the Common Terminology Criteria for Adverse Events, CTCAE version 5) compared to historical controls on 10mg/kg/day of rifampicin.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects with confirmed or probable pulmonary or extra pulmonary DS-TB.
- •Informed consent provided.
- •Positive smear, positive Xpert MTB/RIF test, positive M. tuberculosis culture (confirmed cases) OR histological study compatible with necrotizing granulomas OR a liquid biochemistry (pleural, pericardial, ascites or cerebrospinal fluid) suggestive of TB together with clinical symptoms resembling TB disease in the absence of any other possible cause (probable cases).
- •Female participants of childbearing age must have a negative pregnancy test at baseline.
- •Age ≥ 60 years old; or Age ≥ 18 years and any of the followings: Body mass index ≤ 18.5 Human Immunodeficiency Virus (HIV) infection. Diabetes Mellitus Hepatitis C virus (HCV) infection (positive HCV serology) Hepatitis B virus (HBV) infection (positive HBV surface antigen or anti-core antibodies) Daily alcohol intake ≥ 2 units of alcohol (1 unit of alcohol: 4% alcohol 250ml (ie beer); 4.5% alcohol 218ml (i.e. cider); 13% alcohol 76ml (i.e. wine); 40% alcohol 25ml (i.e. whisky)) Chronic liver disease of any other cause (metabolic, toxic, autoimmune) Central Nervous System TB involvement
排除标准
- •Rifampicin resistance confirmation.
- •Pre-existing epilepsy or psychiatric disorder according to local investigator.
- •Ischemic heart disease OR severe arrhythmia within 6 months OR Atrial Fibrillation with oral anticoagulant therapy indication when transitioning to low-molecular weight heparin is not feasible.
- •Positive pregnancy test
- •Breastfeeding women.
- •The subject used any drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes which are involved in the degradation pathways of rifampicin within the time windows specified in table
- •Barthel index <40 for subjects older than 60 years old.
- •Signs of significant liver disease: o Liver enzymes (AST or ALT) > 5x upper limit of normal o Total bilirubin > 3x upper limit of normal o Subjects with a Child-Pugh grade C cirrhosis or acute decompensation of their chronic liver disease at enrolment. o Any other grade 3-4 hepatobiliary alteration according to the CTCAE v
- •Subjects with known allergy or sensitivity to rifampicin, or any of the other components of DS-TB treatment.
- •Treatment with any of the following: rifampicin, isoniazid, pyrazinamide, ethambutol, levofloxacin, or moxifloxacin within the last month for at least 14 days or current TB treatment for more than 7 days.
- •The subject is enrolled in any other investigational trial that includes a drug intervention.
- •Subjects with solid organ transplantation or bone marrow transplantation.
- •Subjects with an active onco-hematological neoplasm requiring chemotherapy or immune therapy.
- •Previous severe pulmonary disease, other than pulmonary DS-TB, according to local investigator.
结局指标
主要结局
proportion of participants with one or more SAE (i.e. grade 3 or 4 AE) at 8 weeks of treatment
proportion of participants with one or more SAE (i.e. grade 3 or 4 AE) at 8 weeks of treatment
次要结局
- Eficaccy: The proportion of participants with a favorable outcome at 8 weeks of treatment
- Tolerability: proportion of participants having one or more AE in the prospective cohort.
- efficacy: time to sputum culture conversion from positive to negative
- Correlation of the AUC/MIC values with time to sputum culture conversion adjusted with other explanatory covariates
- changes in quality of life questionnaires and in TB associated costs from all sites will be depicted
研究者
ADRIÁN SÁNCHEZ MONTALVÁ
Scientific
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
研究点 (2)
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