Personalized Therapy Durations Defined by the Blood RNA-based Model for Individualizing Treatment in Multidrug-Resistant Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 9
- 主要终点
- Proportion of patients with favourable study outcome 12 months after treatment end
研究概览
简要总结
PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic signature-based model compared to the standardised twenty months treatment in a cohort of multidrug-resistant tuberculosis patients.
详细描述
This study is a non-inferiority, prospective, parallel-group open-label randomized controlled trial. Three hundred forty-two HIV-negative patients diagnosed with pulmonary tuberculosis (TB) and starting a new anti-multidrug-resistant tuberculosis (MDR-TB) treatment cycle will be included in the study. Two randomized arms of 171 patients each will be recruited over the two-year period, each patient will be followed-up over the entire course of anti-TB treatment and one year after the end of therapy. Regular study visits will include physical examination, collection of sputum, blood and urine and filling in the study questionnaire. On the collected specimens standard bacteriological and blood tests, as well as extended immunological analysis, will be performed. In the experimental group, an RNA transcriptomic analysis using RNA-Seq technology will also be performed.
In the control arm, the patients will receive a standardised World Health Organization recommended 20 months treatment while in the experimental arm the treatment duration will be guided by the transcriptomic signature-based model.
Treatment outcomes and level of TB relapse and survival within the follow-up period will be compared between the experimental and control arms. The efficacy of biomarker-guided treatment therapy will be assessed by a comparison of the proportions of favourable study outcome between two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
During the treatment, both Participant and Care Provider will be masked but once the treatment end is achieved, they will be unmasked, and study participation is continued.
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
- •Patient starting an MDR-TB treatment or within the first 4 weeks after treatment initiation and before culture conversion.
- •Rifampicin resistant M. tuberculosis detected in sputum using a nucleic acid amplification test.
- •New case of TB or re-treatment.
- •Can give informed consent at the point of recruitment.
- •Contactable (residing in the area covered by participating TB centres and possessing a landline or a mobile phone).
- •Willing to participate for the entire course of the treatment and extensive follow-up.
排除标准
- •Age <18 years old.
- •Anti-MDR-TB therapy within 6 months prior to the start date of the current treatment cycle.
- •HIV infection.
- •Non-adherent patient with frequent interruptions.
- •Patient in custodianship or guardianship.
- •Late exclusion criterion: no positive cultures at inclusion and within the first 3 months of treatment.
结局指标
主要结局
Proportion of patients with favourable study outcome 12 months after treatment end
时间窗: up to 36 months
The non-inferiority of the experimental arm compared to the control arm will be established if in the Per-Protocol population the difference in proportions of patients with a favourable study outcome between study arms is greater than the lower equivalence margin of 12%. This outcome measure is assessed after up to 24 months of treatment (usually 20 months) plus 12 months of follow-up after the end of treatment.
次要结局
- Proportion of patients who had a treatment failure(up to 24 months)
- Proportion of patients who died of any cause(up to 36 months)
- Proportion of patients who was lost to follow-up during treatment(up to 24 months)
- Proportion of patients who died from TB(up to 36 months)