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临床试验/NCT03137875
NCT03137875已完成不适用

Evaluation of the PCR Using DNA Extracts From Stained Slides and Sputum Collected on Filter Paper for Identification and Detection of Tuberculosis and Multidrug Resistant (MDR) Tuberculosis

Epicentre1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Epicentre
入组人数
122
试验地点
1
主要终点
proportion of positive samples for Mycobacterium tuberculosis detected by PCR from slides and filter papers among samples by microscopy

研究概览

简要总结

Specimen transport from peripheral health structures to the National TB reference laboratory for MDR-TB identification presents a big challenge in term of sample management, safety, contamination and delays. Thus a system that allows specimen to be collected and shipped in a safely manner while reducing the possibilities of contamination, the cost of shipment and especially the time for detection of MDR-TB by using molecular methods would be very useful. Whereas the some studies show promising results for the development and standardization of simple specimen collection and transportation methods for molecular DST, more data is needed before these can be used in routine.

The study described here aims at identifying a suitable method, in terms of adapted sample support (s) (slide, filter paper (FTA, Genocard ...)) and DNA extraction method. If one or several methods are found to give satisfying results, then a larger patient based evaluation of this (these) method(s) for molecular DST will be performed in a second phase. The protocol for the second phase will be prepared separately.

详细描述

The main objective of this study is to evaluate the performance of PCR in identification and detection of tuberculosis using DNA extracts from stained slides (Ziehl Neelsen and Fluorescence) and Filter paper (FTA card and Genocard).

The secondary objectives of this study are to assess the MTB extraction yield from smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand FTA), to determine the amount of sample required to make a detectable PCR reaction and to assess the feasibility of storage and extraction methods.

研究设计

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

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • TB suspect with cough more than 2 weeks

排除标准

  • 未提供

结局指标

主要结局

proportion of positive samples for Mycobacterium tuberculosis detected by PCR from slides and filter papers among samples by microscopy

时间窗: 6 MONTHS

Tests

次要结局

  • To assess the MTB extraction yield from smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand FTA)(6 MONTHS)

研究者

发起方
Epicentre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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