NL-OMON52031尚未招募2 期
Safety of Rifampicin at High Dose for the Treatment of Adult Subjects with Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis - RIAlta study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
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
- 年龄范围
- 18 至 99（—）
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
- •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
排除标准
- •Subjects will be excluded from entry if ANY ONE of the criteria listed below is
- •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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