CTRI/2020/07/026414已完成3 期
endTB: Evaluating Newly approved Drugs for multidrug-resistant TB
Medicins Sans Frontieres2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2020年7月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- The primary efficacy outcome is the proportion of participants with favorable outcome at week 73. A favorable outcome will be defined based on the presence of negative culture results at weeks 65 and 73 and based on the bacteriological, radiological and clinical evolution.
研究概览
简要总结
endTB trial is randomized, controlled, open-label, Phase III clinical trials conducted in a highly heterogeneous patient population (including participants from sites in four continents, with different prevalence of HIV and other co-morbidities) and will result in high-quality evidence that will be generalizable and transformative for the global policies of MDR-TB management.The experimental regimens mainly rely on newly approved or repurposed drugs and avoid drugs to which high rates of resistance have been reported in MDR-TB patient populations.
endTB is a randomized clinical trial that evaluates five all-oral 9 months regimens for FQ-susceptible MDR-TB (endTB regimens 1-5) in comparison to the current 18-20 month standard of care (control). The sample size needed is of 750 participants. Randomization is adapted based on early treatment outcomes using a Bayesian approach.Trial will be conducted at two sites in India and planned to be initiated in June/July 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •A patient will be eligible for randomization if s/he:
- •Has documented pulmonary tuberculosis due to strains of M.
- •tuberculosis resistant to rifampin (RIF) and susceptible to fluoroquinolones, diagnosed by validated rapid molecular test;
- •Is 15 years and more of age;
- •Is willing to use effective contraception: pre-menopausal women or women whose last menstrual period was within the preceding year, who have not been sterilized must agree to use two methods of contraception (e.g., a hormonal method and a barrier method) unless their partner has had a vasectomy; men who have not had a vasectomy must agree to use condoms;
- •Provides informed consent for study participation; additionally a legal representative of patients considered minor per local laws should also provide consent;
- •Lives in a dwelling that can be located by study staff and expects to remain in the area for the duration of the study.
排除标准
- •A patient will not be eligible for randomization if s/he:
- •Has known allergies or hypersensitivity to any of the investigational drugs;
- •Is known to be pregnant or is unwilling or unable to stop breast-feeding an infant;
- •Has any condition (social or medical) which, in the opinion of the site principal investigator, would make study participant unsafe;
- •Has had exposure (intake of the drug for 30 days or more) in the past five years to bedaquiline, delamanid, linezolid, or clofazimine, or has proven or likely resistance to bedaquiline, delamanid, linezolid, or clofazimine (e.g., household contact of a DR-TB index case who died or experienced treatment failure after treatment containing bedaquiline, delamanid, linezolid, or clofazimine or had resistance to one of the listed drugs); exposure to other anti-TB drugs is not a reason for exclusion.b. Has received second-line drugs for 15 days or more prior to screening visit date in the current MDR/RR-TB treatment episode.
- •Exceptions include: (1) patients whose treatment has failed according to the WHO definition151 and who are being considered for a new treatment regimen; (2) patients starting a new treatment regimen after having been “lost to follow-up†according to the WHO definition149 and, (3) patients in whom treatment failure is suspected (but not confirmed according to WHO definition), who are being considered for a new treatment regimen, and for whom the Clinical Advisory Committee (CAC) consultation establishes eligibility.
- •Has one or more of the following: Hemoglobin treater than equal to 7.9 g/dL; Uncorrectable electrolytes disorders: Total Calcium < 7.0 mg/dL (1.75 mmol/L); Potassium < 3.0 mEq/L (3.0 mmol/L) or more than or equal to 6.0 mEq/L (6.0 mmol/L); Magnesium < 0.9 mEq/L (0.45 mmol/L); Serum creatinine > 3 x ULN; Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) more than/equal to 3 x ULN; Total bilirubin 3 x ULN; Albumin < 2.8 g/dL; Unless otherwise specified, Grade 4 result as defined by the MSF Severity Scale (Appendix 2) on any of the screening laboratory tests.
- •Has cardiac risk factors defined as: An arithmetic average of the two ECGs with highest QTcF intervals of greater than or equal to 450 ms.
- •Retesting to reassess eligibility will be allowed using an unscheduled visit during the screening phase; Evidence of ventricular pre-excitation (e.g., Wolff Parkinson White syndrome); Electrocardiographic evidence of either: Complete left bundle branch block or right bundle branch block; OR Incomplete left bundle branch block or right bundle branch block and QRS complex duration > 120 msec on at least one ECG; Having a pacemaker implant; Congestive heart failure; Evidence of second- or third-degree heart block; Bradycardia as defined by sinus rate less than 50 bpm; Personal or family history of Long QT Syndrome; Personal history of arrhythmic cardiac disease, with the exception of sinus arrhythmia; Personal history of syncope (i.e. cardiac syncope not including syncope due to vasovagal or epileptic causes).
- •Is currently taking part in another trial of a medicinal product;
- •Is taking any medication that is contraindicated with the medicines in the trial regimen which cannot be stopped (with or without replacement) or requires a wash-out period longer than 2 weeks.
结局指标
主要结局
The primary efficacy outcome is the proportion of participants with favorable outcome at week 73. A favorable outcome will be defined based on the presence of negative culture results at weeks 65 and 73 and based on the bacteriological, radiological and clinical evolution.
时间窗: week 73
次要结局
- Efficacy: Proportion of participants with favorable outcome at week 39 and 104. A favorable outcome will be defined based on the presence of negative culture results at weeks 36 and 39 and weeks 97 and 104 and based on the bacteriological, radiological and clinical evolution.(Safety: Proportion of patients:)
研究者
研究点 (2)
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