CTRI/2011/05/001745已完成3 期
A randomised placebo controlled double blind trial comparing two treatmentshortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis - REMoxTB
Apothecaries Private limited0 个研究点目标入组 1,900 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,900
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
入选标准
- •A. Signed written consent or witnessed oral consent in the case of illiteracy,
- •before undertaking any trial related activity.
- •B. Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.
- •C. Aged 18 years or over.
- •D. No previous anti-tuberculosis chemotherapy.
- •E. 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.
- •F. Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 & 2).
- •G. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.
- •H. Laboratory parameters performed up to 14 days before enrolment. ?h Serum aspartate transaminase (AST) and alanine transaminase (ALT)
- •activity less than 3 times the upper limit of normal ?h Serum total bilirubin level less than 2.5 times upper limit of normal
- •?h Creatinine clearance (CrCl) level greater than 30 mls/min ?h Haemoglobin level of at least 7.0 g/dL ?h Platelet count of at least 50x109cells/L ?h Serum potassium greater than 3.5 mmol/L
- •I. Negative pregnancy test (women of childbearing potential).
排除标准
- •A. Unable to take oral medication.
- •B. Previously enrolled in this study.
- •C. Received any investigational drug in the past 3 months.
- •D. Received an antibiotic active against M. tuberculosis in the last 14 days
- •(fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
- •E. Any condition that may prove fatal during the first two months of the study
- •F. TB meningitis or other forms of severe tuberculosis with high risk of a poor
- •G. Pre-existing non-tuberculosis disease e.g. diabetes, liver or kidney disease,
- •blood disorders, peripheral neuritis, chronic diarrhoeal disease in which the
- •current clinical condition of the patient is likely to prejudice the response to,
- •or assessment of treatment.
- •H. Pregnant or breast feeding.
- •I. Suffering from a condition likely to lead to uncooperative behaviour e.g.
- •psychiatric illness or alcoholism.
- •J. Contraindications to any medications in the study regimens.
- •K. 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).
- •L. Known allergy to any fluoroquinolone antibiotic or history of tendinopathy
- •associated with quinolones.
- •M. Patients already receiving anti-retroviral therapy.
- •N. Patients whose initial isolate is shown to be multiple drug resistant (i.e.
- •resistant to rifampicin and isoniazid) or monoresistant to rifampicin, or
- •resistant to any fluoroquinolone). (See Section 5.9.2)
- •O. Weight less than 35kg.
- •P. HIV infection with CD4 count less than 250 cells/μL.
- •Q. End stage liver failure (class Child-Pugh C).
研究者
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