An international multicentre controlled clinical trial to evaluate high dose RIFApentine and a QUINolone in the treatment of pulmonary tuberculosis

St. George?s Hospital Medical School (UK)0 个研究点目标入组 1,250 人开始时间: 2007年7月3日最近更新: 2015年1月13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. Either no previous anti-tuberculosis chemotherapy, or less than two weeks of previous chemotherapy
•4. Aged 18 years and over
•5. A firm home address that is readily accessible for visiting and be intending to remain there during the entire treatment and follow up period
•6. Willing to agree to participate in the study and to give a sample of blood for HIV testing

•1. Has any condition (except HIV infection) that may prove fatal during the study period
•2. Has Tuberculous (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-Retroviral Treatment (ART) at diagnosis
•8. Has a history of prolonged QTc syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine during the intensive phase of TB therapy
•9. Haemoglobin less than 7g/l
•10. Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than five times the upper range
•11. Creatinine clearance of less than 30 mls/min
•12. Has a history of seizures
•13. Is HIV positive with a CD4 count of less than 200/mm^3
•14. Weight less than 35 kg
•Added 26/10/2011:
•15. Already receiving anti anti-retroviral therapy (ART)

发起方

St. George?s Hospital Medical School (UK)