CTRI/2019/11/021973
Not yet recruiting
未知
Multi-centre Clinical Trial to Assess the Performance of Culture-free, End-to-end Targeted NGS (tNGS) Solutions for Diagnosis of Drug Resistant TB (DR-TB)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: J709- Respiratory conditions due to unspecified external agent
- Sponsor
- Foundation for Innovative New Diagnostics FIND
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. A clear TB\-positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra prior to enrolment, irrespective of RIF\-resistance status,
- •2\.At risk for drug resistant TB based on at least one of the following risk factors:
- •A.Not responding TB treatment with positive sputum smear or culture after \>\= 3 months of standard TB treatment.
- •B.Previously diagnosed with Rif\-resistant/MDR\-TB and failed TB treatment with positive sputum smear or culture after \>\= 3months of a standard MDR\-TB regiment
- •C.Previously received \>1 month of treatment for a prior TB episode
- •D.Close contact with a known drug\-resistant TB case
- •3\.Willing to provide sputum
- •4\.Over 18 years of age (or legal adult age corresponding to the site)
- •5\.Provision of signed informed consent
Exclusion Criteria
- •1\.Have started treatment for current TB episode more than 7 days prior to date of enrolment (i.e. must have been on treatment for less than 7 days for this TB treatment episode at enrolment)
- •2\.Are pregnant or institutionalized or imprisoned
Outcomes
Primary Outcomes
Not specified
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