Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- The Effectiveness of a WGS DST strategy for individualisation of RR-TB treatment
研究概览
简要总结
The primary aim of this pragmatic trial is to determine the effectiveness of a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB) patients.
The primary objective is to determine the effectiveness of this WGS DST strategy in patients diagnosed with RR-TB. We will additionally perform an exploratory health economics evaluation of both arms, and will determine the feasibility of the WGS DST strategy.
详细描述
The trial will be a single blinded randomised controlled, pragmatic, medical device trial evaluating a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB) patients. A total of 248 patients diagnosed with RR-TB in the South African Free State province will by randomised to one of two trial arms. 124 patients will be assigned to the intervention arm, consisting of a WGS DST strategy for diagnosing drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation. 124 patients will be assigned to the control arm where the diagnosis of Mtb drug resistance and individualisation of RR-TB treatment will happen according to the Standard of Care (SOC) procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with RR-TB
- •Diagnosed with pulmonary TB (PTB) or PTB plus extra-pulmonary TB (EPTB)
- •≥18 years of age
- •Able to sign informed consent
- •Not on TB treatment at time of enrolment
排除标准
- •Patients diagnosed EPTB without pulmonary involvement
- •Patients with TB Meningitis or TB of the bone.
- •Has any condition that, in the opinion of the investigator or physician, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives or compromise patient safety.
研究组 & 干预措施
WGS DST strategy
WGS DST strategy for diagnosing the TB drug resistance profile and an individualised RR-TB treatment recommendation
干预措施: WGS DST strategy (Device)
Standard of Care
Standard of care diagnosis of the drug resistance profile and individualised treatment
结局指标
主要结局
The Effectiveness of a WGS DST strategy for individualisation of RR-TB treatment
时间窗: Day 0 to month 6 (6 months)
The effectiveness will be determined by the rate of change in time to positivity (TTP) over 6 months in the Mycobacterial Growth Indicator Tuber (MGIT) system \[time from: Day 0 to Week 24\]. The effectiveness of the WGS DST strategy will be determined by the rate of change in TTP in liquid media MGIT cultures of sputum samples collected during the first 6 months of treatment. The TTP will be used to determine the change in mycobacterial load using a non-linear mixed effect time-to-event model that provides a longitudinal representation of mycobacterial load (measured as TTP in MGIT) at weeks 2, 3, 4, 5, 6, 7, 8, 12, 16, 20 and 24
次要结局
- Health economic evaluation of a WGS DST strategy for individualization of RR-TB treatment(Start of treatment to end of treatment (which may vary from 6 months to over 11 months))
- Impact of WGS strategy for individualisation of RR-TB treatment on Health related Quality of Life (HRQOL)(Start of treatment to end of treatment (which may vary from 6 months to over 11 months))
研究者
Annelies Van Rie
Professor
Universiteit Antwerpen