EUCTR2021-001626-22-ES进行中（未招募）1 期
A Multicentre Controlled Open Randomized Clinical Trial to evaluate the efficacy and safety profile of an anti-TB drug combination based on High Dose Rifampicin, High Dose Moxifloxacin and Linezolid daily for DS AFB smear positive pulmonary TB patients during the initial 8 weeks of treatment. - RML-TB study
Vall d'Hebron Institute of Research0 个研究点目标入组 120 人开始时间: 2022年3月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Diagnosis of AFB smear-positive pulmonary TB. 2) Age = 18 years. 3) Sign informed consent. 4) Negative pregnancy test (women of childbearing age)
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Contact of a patient with multidrug-resistant TB. 2) Multidrug-resistant TB or monoresistance to any first-line drugs (except ethambutol). 3) AFB smear-positive pulmonary TB with negative mycobacterial culture. 4) Barthel <60 or if the investigator considers that there is a risk of death in the following month. 5) Weight <40 kg. 6) Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days: randomization: azithromycin, chloroquine, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone. 7) Cirrhosis Child C. 8) User of abuse drugs (including alcohol) according to investigator criteria. 9) Patients with solid organ or bone marrow transplantation. 10) Patients under treatment with anti-TNF or other immunosuppressive drugs. 11) Patients with oncohematological diseases. 12) Advanced lung disease according to investigator criteria. 13) Epilepsy or uncontrolled psychiatric disorder according to the investigator criteria. 14) History of ischemic heart disease or severe arrhythmia in the last 6 months. 15) Long QT syndrome or family history of sudden death. 16) Patient living in HIV infection. 17) Breastfeeding women. 18) Intolerance or allergy to any of the study drugs. 19) History of TB in the previous year. 20) Laboratory alterations: a) AST or ALT> 3x Upper limit of normality b) Bit> x3 Upper limit of normality c) Hb <6.5g/dl d) Platelets <40000/mm3 e) Potassium <3.2 mmol/L f) Glomerular filtration <30 mL /min/1.73m2. 21) ECG alterations: a) QTcF > 0.5s b) Other clinically relevant changes in the ECG according to investigator criteria. 22) Treatment with any of the study drugs in the last month for more than 7 days.
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