Performance of the Molecular Test Xpert MTB/RIF Ultra for Early Detection of Tuberculosis at Primary Health Care Facilities in Georgia: a Parallel Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 778
- 试验地点
- 2
- 主要终点
- Time from enrolment to TB diagnosis
研究概览
简要总结
Tuberculosis (TB) is the leading cause of death caused by infectious agent globally. Estimated 10 million people get ill with TB every year and in 2022 globally there was an increase in Tuberculosis cases, first time since 2010. While in previous years, the decrease in TB numbers was reflecting the impact of disruptions to essential TB services during the COVID-19 pandemic, the increase in numbers in following years have highlighted how severe this disruptions impacted essential TB services.
Access to early diagnosis, including drug resistance testing, is essential in the cascade of care. Early diagnosis enables a timely and adequate start of treatment, reducing TB transmission and increasing the likelihood of favorable outcomes of treatment. Most of the tests that are used today to diagnose TB are slow and difficult to use. A few years ago, a new simple and sensitive test for detection of TB was introduced, the Xpert MTB/RIF. A new version of this, Xpert Ultra (Ultra) has been developed.
National Center for Tuberculosis and Lung Diseases in collaboration with Swiss Tropical and Public Health Institute is investigating whether new test Xpert / Ultra, when carried out at the Primary Health Care facilities, would help patients in getting a fast and reliable TB diagnosis in the country of Georgia.
The study will involve approximately 1600 participants. The study was approved by the local Ethics Committee of the National Center for Tuberculosis and Lung Diseases.
详细描述
BACKGROUND INFORMATION The use of the rapid diagnostic test Xpert MTB/RIF (Xpert) for simultaneous detection of Mycobacterium tuberculosis and Rifampicin resistance has been scaled up in recent years globally, but real-life effectiveness studies could not demonstrate the expected beneficial impact on patient important clinical outcomes such as: time to diagnosis, time to treatment initiation and mortality among others.
The ideal rapid diagnostic tool should demonstrate better sensitivity and most importantly contribute to the detection of more TB cases and decreased time to diagnosis at decentralized Health Care facilities closest to the homes of the patients.
The new highly sensitive Xpert® MTB/RIF Ultra (Ultra) assay on GeneXpert® platform have the potential to overcome the limitations of Xpert by providing molecular TB testing with an improved sensitivity operating at peripheral facilities.
The presented study will assess the clinical impact and operational characteristics of Ultra at decentralized Primary Health Care (PHC) level, compared to existing routine diagnostic algorithm based on Xpert at specialized central TB service points (TB Cabinets).
OBJECTIVES AND PURPOSE In 2010, the World Health Organization (WHO) endorsed Xpert MTB/RIF, a rapid molecular diagnostic test with good performance characteristics[2,3]. In smear-positive patients, the test has a pooled sensitivity of 89%, whereas the pooled sensitivity in smear-negative, culture-positive patients is only 67%. Specificity is excellent in both groups at 99%[4].Xpert has been successfully rolled out in most high TB burden countries. However, efficacy trials showing excellent results were not further supported by real world effectiveness studies done after implementation of test by National TB Programs. In addition, tests in most cases have not been brought to the point of care level and thus could not pose a significant change.
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
- •Presumptive pulmonary TB patients, as defined by the NTP treatment guidelines.
- •Adults 18 years old and above
排除标准
- •Patients with symptoms which are only attributable to extra-pulmonary TB
- •Patients below the age of 18 years
结局指标
主要结局
Time from enrolment to TB diagnosis
时间窗: Time interval between first approach to PHC and TB diagnosis
Time interval between first approach to PHC and positive TB diagnosis based on laboratory results (i.e. smear, culture, Xpert, Ultra) or clinical judgement
Proportion of participants who have bacteriologically confirmed TB and have TB therapy initiated within 7 (30) days of enrolment
时间窗: At 7 (30) days from bacteriological confirmation
Numerator: Participants with positive smear, culture, Xpert or Ultra result and who are on TB treatment 7 (30) days after enrolment Denominator: All participants of the study arm.
次要结局
- Number of presumptive TB cases at the PHC facility(At baseline)
- Proportion of patients with early stage TB disease(From the onset of TB symptoms till the date of diagnostic procedures (X-ray and microscopy) at specialized TB clinics)
- Time from onset of symptoms to diagnosis(Time interval between first TB symptom and TB diagnosis)
- Proportion of patients with unfavorable outcomes(Unfavorable outcomes after enrolment and loss to follow up measured at 6 months)
- All-course mortality(Within 12 months from the end of last patients enrolment)
研究者
Nestani Tukvadze
MD. Principal Investigator
Swiss Tropical & Public Health Institute