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临床试验/CTRI/2018/06/014611
CTRI/2018/06/014611招募中不适用

Establishing TB portal of Mycobacterium tuberculosis patients from tertiary care hospital in Southern India

CRDF1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年6月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
CRDF
入组人数
300
试验地点
1
主要终点
MDR positive or negative

研究概览

简要总结

1. Justification for study

Centralized databases, curated from collaborative efforts of TB endemic countries can help the researchers identify global trends and important biological features which would be only possible by comprehensive analysis of combined data. On an average, 677 cases are being presented in KMC Manipal every year from 2012-2016. The data from these many cases can be a lucrative for TB portal.

Implementation of the TB portal will also enable us to follow-up all the patients. This will have an improved patient outcome assessment by measuring the medication adherence and treatment outcome. The genomic data obtained will help in identifying the genome of TB resistant strains of the region specific TB cases.

We carried out whole genome sequencing of 246culture confirmed Mycobacterium tuberculosis clinical samples(convenient cohort sampling) from TB patients of Kasturba Hospital, Manipal andUdupi district Hospital, which are 2 major referral hospitals of Udupidistrict, Karnataka state.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All pulmonary Tb Patients admitted in Hospital are considered for the study.

排除标准

  • Terminally ill cancer Patients.

结局指标

主要结局

MDR positive or negative

时间窗: 3,6,12,24,48 months after first Diagnosis

次要结局

  • Death(Time till follow up)

研究者

发起方
CRDF
申办方类型
Government funding agency

研究点 (1)

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