PER-098-09已完成未知
A Randomised Placebo - Controlled Double Blind Trial Comparing 1) a Two Month Intensive Phase of Ethambutol, Moxifloxacin, Rifampicin, Pyrazinamide Versus the Standard Regimen (Ethambutol, Isoniazid, Rifampicin, Pyrazinamide) and 2) a Treatment Shortening Regimen Comparing Two Months Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide Followed by Two Months Moxifloxacin, Isoniazid, Rifampicin Versus the Standard Regimen (Two Months Ethambutol, Isoniazid, Rifampicin, Pyrazinamide Followed by Four Months Isoniazid and Rifampicin) for the Treatment of Adults With Pulmonary Tuberculosis
niversity College London,0 个研究点目标入组 0 人开始时间: 2009年11月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 年龄范围
- 18 至 150（—）
- 性别
- All
入选标准
- •Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity.
- •Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.
- •Aged 18 years or over.
- •No previous anti-tuberculosis chemotherapy.
- •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.
- •Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 & 2).
- •Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.
- •Laboratory parameters performed up to 14 days before enrolment.
- •Negative pregnancy test (women of childbearing potential).
排除标准
- •Unable to take oral medication.
- •Previously enrolled in this study.
- •Received any investigational drug in the past 3 months.
- •Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
- •Any condition that may prove fatal during the first two months of the study period.
- •TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
- •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.
- •Pregnant or breast feeding.
- •Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
- •Contraindications to any medications in the study regimens.
- •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).
- •Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones.
- •Patients already receiving anti-retroviral therapy.
- •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)
- •Weight less than 35kg
- •HIV infection with CD4 count less than 250 cells/µL.
- •End stage liver failure (class Child-Pugh C).
研究者
相似试验
招募中
Unknown
effects of melatonin as premedication agent in caesarean sectioEfficacy of melatonin to patient with caesarian section under spinal anesthesia with ASA I and ASA II.F06.4anxietyIRCT20230809059105N1Alayen universty80
已完成
3 期
PTX and Contrast Induced Nephropathypatients candidate for percutaneous coronary intervention.???????? ???? ??? ?????? ???? ??????? ???? ??????? ? ??????IRCT2016111530905N1Imam Hossein Hospital110
已完成
3 期
Ayurvedic formulation in the management of COVID patients in rural IndiaCTRI/2021/10/037442Sriveda Sattva Pvt Ltd100
尚未招募
3 期
A Randomized Double-blinded Placebo-controlled Trial of Prophylactic Rectal Indomethacin for Prevention of Post-embolization Syndrome in Patients with Hepatocellular CarcinomaPost-embolization syndromeRectal indomethacinTACEInterleukin-6Interleukin-13TNF-alphaICAM-1Hepatocellular carcinomaTCTR20210209002In process for Ratchadaphiseksomphot Endowment Fund submission120
进行中（未招募）
1 期
A Clinical Trial of Scopolamine Versus Placebo for Individuals with Bipolar Disorder who are Experiencing a Depressive Episode (SCOPE-BD)MedDRA version: 20.0Level: LLTClassification code 10004937Term: Bipolar disorder NECSystem Organ Class: 100000004873Bipolar DisorderEUCTR2017-003112-39-IEational University of ireland Galway60