Evaluation of the Efficacy and Safety of a Combination regimen of Bedaquiline, Delamanid, Linezolid and Clofazimine in Adults with Pre-extensive (Pre-XDR) and Extensively Drug-resistant Pulmonary Tuberculosis (XDR-TB):Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 165
- 试验地点
- 5
- 主要终点
- Cure rate at end of treatment with study regimen
研究概览
简要总结
Currently treatment for drug resistant pulmonary TB is long-drawan (18-20 months) with an injectable and many toxic drugs. Inspite of this the cure rate is low and the default rates are high either dur to the long drawn treatment course or due to drug toxicity. With the availability of two new drugs, bedaquiline and delmanid with a new mechanism of action, there is an opportunity now to combine these drugs and plan a shorter and less toxic regimen for the management of these patients. Hence we propose to evaluate the efficacy of a new fully oral non-injectable treatment regimen of 6-9 months duration consisting of Bedaquiline (BDQ), Delamanid (DLM), Linezolid (LZD) and Clofazimine (CFZ) in adult patients with pre-extensive (pre-XDR) or extensively drug resistant (XDR) pulmonary tuberculosis. The study will also evaluate the safety and tolerability of this treatment regimen and also determine the time to sputum culture conversion with this combination treatment regimen. We will also determine the steady state blood levels of the new study drugs and their metabolites. This is a multi-centric study being planned in 5 sites of the country ver a period of 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Men or women aged 18 years and above 2.Multiple Drug Resistant TB documented by culture positive sputum for Mycobacterium tuberculosis with documented resistance to Rifampicin, with or without Isoniazid, AND Fluoroquinolone or a second line injectable (Pre-XDR) OR both Fluoroquinolone and a second line injectable (XDR) 3.A minimum of two positive sputum smears for acid-fast bacilli or at least one culture positive with negative sputum smears from specimens collected no more than 6-weeks 4.Chest X-Ray results consistent with pulmonary TB along with points 2 & 3 5.Body weight of ≥30 kg 6.Willingness and ability to attend scheduled follow-up visits and undergo study assessments 7.Provide written informed consent 8.Provide consent to HIV testing ( 9.If male or female participant of childbearing potential, willingness to use effective methods of birth control.
排除标准
- •1.Unstable disease i.e uncontrolled diabetes,cardiomyopathy,extra pulmonary TB,significant cardiac arrhythmias.
- •2.Current Hepatitis B & C, HIV, alcohol, barbiturates,amphetamine,narcotic use.
- •3.History of previous treatment with Bedaquiline or Delamanid.
- •4.Females with positive pregnancy test at screening or planning to conceive during study or within 6 months of cessation of drugs.Males planning to conceive during study or within 6 months of cessation of drugs.
- •5.Study participants with abnormal liver function test,hemogram,creatinine laboratory values.
- •Grade II peripheral newuropathy.
结局指标
主要结局
Cure rate at end of treatment with study regimen
时间窗: 6-9 months
次要结局
- 1.Incidence of bacteriological relapse during 48 weeks post treatment follow-up.(2.Incidence of bacteriological failure or clinical failure during treatment period.)