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临床试验/NCT06409572
NCT06409572尚未招募不适用

Study of GeneXpert MTB/RIF Versus the Routine Methods for Detection of Mycobacterium Tuberculosis

Sohag University0 个研究点目标入组 80 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB.

研究概览

简要总结

  1. Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB.
  2. To assess the GeneXpert MTB/RIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples.

详细描述

Tuberculosis (TB) infection, caused by Mycobacterium tuberculosis, is a leading cause of mortality worldwide and ranks among the deadliest infectious diseases, including HIV and malaria. Despite global efforts, TB remains a significant public health threat, particularly in developing and underdeveloped countries. The World Health Organization (WHO) has reported that an estimated 10.4 million people contract new TB infections yearly, with 1.8 million TB-related deaths occurring annually.

TB usually affects the lungs, but it can also affect other parts of the body, such as the brain, spine, and many other organ systems. The most common form is pulmonary TB, which is easily spread by aerosol droplets. If another person inhales air containing these droplet nuclei, the probability of getting infected is very high. The chance of transmissibility increases if there is a delay in disease detection and treatment initiation.

Tuberculosis is an infection that requires extensive treatment. Active pulmonary TB patients can transmit the infection through the air then the droplet nuclei move through upper respiratory tract and bronchi to reach the lungs alveoli.

It is critical to treat active pulmonary TB patients as soon as possible in order to decrease the danger of infection spreading to others. The initial stage in TB diagnosis is sputum acid fast bacillus (AFB) staining, which has an advantage of having an average turnaround time (TAT) about 24 hours.

There are a number of tests available for the diagnosis of tuberculosis each having their own limitations. Conventional microscopy has low sensitivity and culture requires longer time for positivity. The commercially available automated, liquid Mycobacterium Growth Indicator tube (MGIT) culture system is time-consuming and requires specialized laboratories. On the other side, nucleic acid amplification techniques not only provide the advantage of rapidity of diagnosis but also detect even low genomic copies in various specimens and curtail the transmission of the disease.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All suspected tuberculous patients.

排除标准

  • Previously diagnosed patients.

结局指标

主要结局

Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB.

时间窗: Baseline

次要结局

未报告次要终点

研究者

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

Esraa Hussien Mahran Shehata

Principal Investigator

Sohag University

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