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Clinical Trials/CTRI/2019/11/021973
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

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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