跳至主要内容
临床试验/CTRI/2019/02/017549
CTRI/2019/02/017549已完成不适用

CB-NAAT, Its clinical utility in diagnosing cases of cutaneous tuberculosis and assessing rifampicin resistance.

King Georges Medical University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年2月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
examination (including staining for AFB) in diagnosing cases of cutaneous TB.

研究概览

简要总结

It is a prospective study to compare the diagnostic efficacy of CB-NAAT, culture and histopathology in cases of skin tuberculosis. It also aims at knowing the efficacy of CB-NAAT in detecting rifampicin resistance and comparing it with DST (Culture) results in positive culture cases.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • (a) Patients clinically diagnosed as cutaneous TB and who give consent to participate in the study.

排除标准

  • (a) Who have taken ATT in last one year (b) Contra-indication for biopsy or FNAC like bleeding and clotting disorders (c) Patients with severe debilitating and chronic illness like Hepatitis B,C, malignancy, uncontrolled diabetes etc (d) Not willing to participate in study.

结局指标

主要结局

examination (including staining for AFB) in diagnosing cases of cutaneous TB.

时间窗: 1.5 years

To assess and compare the efficacy of CBNAAT, culture and histopathological

时间窗: 1.5 years

次要结局

  • Assessment and comparison of Rifampicin resistance results shown(by CBNAAT and DST (for cases that show culture growth).)

研究者

发起方
King Georges Medical University
申办方类型
Government medical college

研究点 (1)

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