EUCTR2020-003146-36-NL招募中1 期
Safety of Rifampicin at High Dose for the Treatment of Adult Subjects with Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis - RIAlta study
Vall d'Hebron Research Institute (VHIR)0 个研究点目标入组 134 人开始时间: 2022年9月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 134
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •The participant must fulfill either criteria nr. 1-4 AND nr. 5 OR criteria nr. 1-4 AND 6, AND anyone of 7-14:
- •1. Subjects with confirmed or probable pulmonary or extra pulmonary DS-TB.
- •2. Informed consent provided.
- •3. 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).
- •4. Female participants of childbearing age must have a negative pregnancy test at baseline.
- •5. Age = 60 years old.
- •6. Age = 18 years
- •AND one of the following
- •7. Body mass index = 18.5
- •8. Human Immunodeficiency Virus (HIV) infection.
- •9. Diabetes Mellitus
- •10. Hepatitis C virus (HCV) infection (positive HCV serology)
- •11. Hepatitis B virus (HBV) infection (positive HBV surface antigen)
- •12. 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))
- •13. Chronic liver disease of any other cause (metabolic, toxic, autoimmune)
- •14. Central Nervous System TB involvement
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Subjects will be excluded from entry if ANY ONE of the criteria listed below is met:
- •1. Rifampicin resistance confirmation.
- •2. Barthel index <40 for subjects older than 60 years old.
- •3. Signs of liver disease not related to TB [Liver enzymes (AST or ALT) > 5x upper limit of normal , Total bilirubin > 5x upper limit of normal, Patients with a Child-Pugh grade C cirrhosis or acute decompensation of their chronic liver disease at enrolment.]
- •4. Subjects with known allergy or sensitivity to rifampicin, or any of the other components of DS-TB treatment.
- •5. 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.
- •6. The subject is enrolled in any other investigational trial that includes a drug intervention.
- •7. Subjects with solid organ transplantation or bone marrow transplantation.
- •8. Subjects with an active onco-hematological neoplasm.
- •9. Previous severe pulmonary disease, other than pulmonary DS-TB, according to local investigator.
- •10. Pre-existing epilepsy or psychiatric disorder according to local investigator.
- •11. 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.
- •12. Positive pregnancy test
- •13. Breastfeeding women.
- •14. 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 the protocol.
研究者
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