ISRCTN85595810已完成未知
Controlled comparison of two moxifloxacin containing treatment shortening regimens in pulmonary tuberculosis
niversity College London (UK)0 个研究点目标入组 1,500 人开始时间: 2007年3月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
研究概览
简要总结
- 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25196020 (added 10/04/2019) 2. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26847437 (added 10/04/2019) 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29779774 (added 10/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity
- •2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy at the local laboratory
- •3. No previous anti-tuberculosis chemotherapy
- •4. Aged 18 years and over
- •5. A firm home address that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and follow-up period
- •6. Agreement to participate in the study and to give a sample of blood for Human Immunodeficiency Virus (HIV) testing
- •7. Laboratory parameters performed up to 14 days before enrolment
- •8. Serum aspartate aminotransferase (AST) activity less than three times the Upper Limit of Normal (ULN)
- •9. Serum total bilirubin level less than 2.5 times ULN
- •10. Creatinine Clearance (CrCl) level greater than 30 mls/min
- •11. Haemoglobin level of at least 7.0 g/dL
- •12. Platelet count of at least 50 x 10^9 cells/L
- •13. Serum potassium greater than 3.5 mmol/L
- •14. Negative pregnancy test (women of childbearing potential)
- •15. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an Intra-Uterine Contraceptive Device (IUCD) in place
排除标准
- •1. Unable to take oral medication
- •2. Previously enrolled in this study
- •3. Received any investigational drug in the past three months
- •4. Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs)
- •5. Any condition that may prove fatal during the first two months of the study period
- •6. TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
- •7. Pre-existing non-tuberculosis disease likely to prejudice the response to, or assessment of, treatment e.g. insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis, chronic diarrhoeal disease
- •8. Pregnant or breast feeding
- •9. Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism
- •10. Contraindications to any medications in the study regimens
- •11. Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
- •12. End stage liver failure (class Child-Pugh C)
- •13. Uncorrected hypokalaemia
- •14. Weight less than 35 kg
- •15. Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones
- •16. HIV infection with CD4 count less than 250 x 10^9/lit
- •17. Patients already receiving anti-retroviral therapy
- •18. Patients whose initial isolate is shown to be multiple drug resistant
研究者
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