Evaluation of the Feasibility, Accuracy, and Effect of a Rapid Point-of-Care Serological Triage Test for Active TB (SeroSelectTB) in High Burden, HIV-endemic African Settings: a Multi-centre, Parallel-group, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,097
- 试验地点
- 3
- 主要终点
- To determine the impact of SeroSelectTB on health systems' diagnostic delay in Ethiopia, Tanzania and South Africa.
研究概览
简要总结
The performance of a new triage test for active tuberculosis (TB), SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia. Cost effectiveness evaluations will be conducted to support a value proposition to stakeholders and regulatory authorities, and to support commercialization requirements.
Consenting adults will provide blood and saliva samples for screening by SeroSelectTB, and sputum collected for routine TB diagnosis by the health services. Clinical and sociodemographic information will be collected.
A reliable rapid test will make it possible to identify and selectively treat those with active TB at the local healthcare level. The expected impact includes accurate same-day diagnosis of patients with active TB, reduction of diagnostic delay and TB transmission, and diagnostic cost-savings for patients and healthcare systems in high TB-burden countries.
详细描述
Purpose: Worldwide over 15 million persons live with active TB. While the prevalence of latent TB is very high, only disease, and not latent infection, is treated in most high burdened countries.
A rapid triage test for detection of active TB, which can identify symptomatic individuals who require confirmatory diagnostic investigation, is a global priority for TB control. A rapid triage test can drastically reduce the burden on health systems and patients, and reduce diagnostic delay by expediting referral, confirmatory testing and timely commencement of adequate treatment. Triage tests, which may utilise point- of-care rapid lateral flow (LF) platforms, offer a promising alternative to conventional methods for TB diagnosis (i.e. smear microscopy and culture). However, the lack of accurate TB biomarkers has stalled the development of serological assays that meet the World Health Organization (WHO)-defined criteria for a triage test.
As an alternative, a rapid molecular diagnostic tool, maned Xpert and Xpert Ultra MTB/RIF, which accurately detects active TB, has been introduced in many countries as a replacement for smear microscopy and culture. However, Xpert/Ultra is not suited for use at health-posts without electricity or laboratory facilities, where the majority of patients present. In addition, the affordability of scaling-up Xpert is of concern in high TB-burden countries, where it could consume 20-80% of national TB budgets.
Therefore, to control the emergence and spread of antibiotic resistant TB in a cost-effective manner, there is an urgent need for a rapid, inexpensive triage test that can detect active TB at health-posts level and expedite referral to facilities supporting molecular diagnostics. An ideal cost-effective triage test should be as sensitive as Xpert and cost less than US $5 to reduce total diagnostic costs by 30-40%, potentially saving national TB programmes US $36 million/year.
The expected outcome of this project, the implementation of a triage test that will detect active TB at a low diagnostic cost, and expedite persons with TB-indicative symptoms to centralized healthcare facilities, will be beneficial irrespective of age and gender of patients. In addition, SeroSelectTB is sensitive among adults co- infected with TB/HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •18 years of age or older
- •Informed Consent Form signed
- •Unwell, suspected to have TB or pneumonia
排除标准
- •Currently receiving TB treatment
- •On TB treatment past 30 days or more, or last dose less than 1 month before enrolment
研究组 & 干预措施
Standard of Care
The participants in this arm, after providing informed consent, will receive the established standard of care.
SeroSelectTB
The participants in this arm, after providing informed concent, will be tested using the SeroSelectTB rapid assay.
干预措施: SeroSelectTB rapid TB test (Diagnostic Test)
结局指标
主要结局
To determine the impact of SeroSelectTB on health systems' diagnostic delay in Ethiopia, Tanzania and South Africa.
时间窗: The time points will be measure from the data of SeroSelectTB test or standard-of-care until the start of treatment (when active TB is diagnosed). Participants receiving TB therapy will be followed for 6 months according to national routines.
Our hypothesis is that the use of a rapid triage assay at patients' first encounter with the healthcare system will, when compared to the standard-of-care, reduce time to TB diagnosis. The assessment of the primary objective will be based on two complementary measures: primary measure is time to diagnosis (measured in days), and secondary measure is time to treatment (measured in days).
次要结局
- To describe SeroSelectTB performance in field conditions, including sensitivity and specificity, and positive and negative predictive values, in the study populations.(Investigations will be performed during the intervention.)
- Evaluate cost-effectiveness of SeroSelectTB.(Cost effectiveness will be determined at year 6.)