An international multicentre controlled clinical trial to evaluate the toxicity of high dose rifampicin in the treatment of pulmomary tuberculosis (RIFATOX)

St George's University of London (UK)0 个研究点目标入组 300 人开始时间: 2010年11月9日最近更新: 2017年10月9日

适应症

试验速览

暂无简介。

•1. Newly diagnosed pulmonary tuberculosis
•2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy
•3. No previous anti-tuberculosis chemotherapy
•4. Aged 18 years and over
•5. A firm home address that is readily accessible for visiting and be intending to remain there or within the recruitment area for the entire treatment period
•6. Agree to participate in the study and to give a sample of blood for HIV testing
•7. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an interuterine contraceptive device (IUCD) in place for the duration of the treatment phase

•1. Has any condition (except HIV infection) that may prove fatal during the study period
•2. Has TB meningitis
•3. Has pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g. insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis
•4. Is female and known to be pregnant, or breast feeding
•5. Is suffering from a condition likely to lead to uncooperative behaviour such as psychiatric illness or alcoholism
•6. Has contraindications to any medications in the study regimens
•7. Requires anti-retro viral treatment (ART) at diagnosis
•8. Haemoglobin <7g/l
•9. Asparate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 5 times the upper limit of normal (ULN) for that laboratory
•10. Creatinine clearance of < 30mls/min
•Calculated as ((140-age) x weight x 1.23 x (0.85 if female))/Creat[micromol/l)
•11. Has glucose in urine
•12. Is HIV positive with a CD4 count of less than 350/mm3
•13. Weight < 35kg

发起方

St George's University of London (UK)