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临床试验/NCT06058065
NCT06058065尚未招募不适用

Value of Xpert® MTB/RIF Ultra in Cases With Suspected Tuberculosis

Assiut University0 个研究点目标入组 200 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Sensitivity and Specificity of Xpert MTB/RIF Ultra

研究概览

简要总结

To estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults suspected to be infected with mycobacterium tuberculosis. In addition, this study will estimate the pattern of rifampicin resistance among TB cases in Assiut population.

详细描述

Xpert MTB/RIF was introduced recently and added great benefit in management of TB. Xpert MTB/RIF revolutionized the management of Mycobacterium tuberculosis (MTB) infections by providing faster and more accurate MTB diagnosis that detects MTB and rifampicin (RIF) resistance simultaneously. Following World Health Organization (WHO) endorsement in 2010, Xpert MTB/RIF has helped improve TB programs in over 130 countries5.

Building on this success, faster and more accurate detection of MTB from the first point of encounter in the community is critical. Partnered with GeneXpert® Systems, Xpert MTB/RIF Ultra was delivered with the advantages of improved performance and faster time to result (results within 80 minutes). It has higher sensitivity especially in smear-negative TB cases. The processing of the new assay is easy to use and does not need special expertise5. Xpert MTB/RIF Ultra has increased accuracy of Rifampicin results and improved detection of mixed infections. Recently published recommendations by global experts demonstrate the efficiency of using Xpert MTB/RIF Ultra as a frontline test over smear microscopy or line probe assays followed by culture-based methods for drug susceptibility testing. Thus, a single modification of the diagnostic algorithm to detect smear-positive and smear-negative TB patients improves active case management, is more cost-efficient and could potentially reduce the relative rate of transmission. Using Xpert MTB/RIF Ultra has the potential to reduce the number of missed smear-negative TB patients and may lead to a decrease in total costs of patient care due to the detection of MTB in patient specimens and RIF-resistance in a single test. There is great need for further research to assess the diagnostic value of Xpert MTB/RIF Ultra in patients with pulmonary tuberculosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presented to Chest Department with suspected pulmonary or extrapulmonary Tuberculosis will be sequentially included

排除标准

  • Age: less than 18 years. Patients who received anti tuberculous drugs in the past 6 months. Unstable patients or need for ICU admission

结局指标

主要结局

Sensitivity and Specificity of Xpert MTB/RIF Ultra

时间窗: Baseline

By compare with other test

次要结局

  • Prevalence of rifampicin resistance among patients with TB active infection presented to Chest Department in Assiut University Hospital(base line)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hend Mohamed Sayed Mohamed

Lecture of chest diseases

Assiut University

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