Multicentre trial to assess the performance of centralized assay solutions for detection of MTB and resistance to Rifampin and Isoniazid (Protocol Version Number v3.0)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy for RIF/INH detection: clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing
研究概览
简要总结
Tuberculosis (TB) isone of the commonest communicable diseases and a leading cause of mortality andmorbidity worldwide, especially in developing countries. World HealthOrganization (WHO) in 2016 considered TB as the top infectious killer which caused1.8 million deaths in the year 2015. As per Global TB Report 2016, India has2.8 million new cases of TB and 1,30,000 cases of MDR TB annually. It has alsohighest TB-HIV co-morbidity in the world and an estimated 1.1 lakh HIVassociated TB occurred in 2015 and 37,000 estimated number of patients diedamong them. In order to control TB, a highly specific and sensitive rapiddiagnostic test is prerequisite for early and effective treatment of TBpatients there by breaking the transmission chain. In December 2010, WHOrecommended use of CB-NAAT for detection of TB and rifampicin resistance in clinical specimens. In order to know the isoniazid sensitivityadditionally, the smear positive sputum specimens were subjected Line Probe Assays (LPAs). Hence combining thetwo tests the turnaround time takes about 5-6 days usually in programmaticcondition. However, while the simplicity of the design (from the operatorperspective) is a key advantage in many settings, it is less crucial inrelatively well-equipped centralized laboratories. Instrument/assaycombinations that are designed for this level of the healthcare system shouldin principle is able to achieve similar performance with higher throughput andat a lower per-sample cost – a key advantage in the resource-limited settingswhere TB is most common and where highly decentralised testing is economicallyunfeasible. Several novel assays have been recently developed/CE-marked thatare all aimed at use in centralized laboratories with potential for high samplethroughput and high accuracy for detection of MTB as well as RIF- andINH-resistance. However, published data on their performance and operationalcharacteristics is extremely limited. This study may help immensely to the TBelimination programme of India as high through put and less TAT are thepredominant characteristic of the intended study
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged 18 years or more Clinical suspicion of pulmonary TB including cough ≥2 weeks and any other symptom typical of pulmonary TB listed below Fever Malaise Recent weight loss Night sweats Contact with active case Haemoptysis Chest pain Loss of appetite.
排除标准
- •Unwilling or unable to provide informed consent Unwilling to provide two sputum specimens at enrolment Patients with only extra-pulmonary TB signs & symptoms Receipt of any dose of TB treatment within 6 months prior to enrolment.
结局指标
主要结局
Diagnostic accuracy for RIF/INH detection: clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing
时间窗: seven days
Diagnostic accuracy for MTB detection: clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard.
时间窗: seven days
次要结局
- Diagnostic accuracy for MTB detection: clinical point estimates of sensitivity and specificity measured against mycobacterial culture as the reference standard by subgroup.(Operational characteristics: description of operator experience with the assays through daily observed usage anduser appraisal questionnaires)