Gene Xpert XDR-TB Kit Evaluatio
Phase 2
- Conditions
- Health Condition 1: J708- Respiratory conditions due to other specified external agents
- Registration Number
- CTRI/2019/07/020139
- Lead Sponsor
- Foundation for Innovative New Diagnostics India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age 18 years and above
Symptoms suggesting pulmonary TB
Previously received more than 1 month of treatment for prior TB episode
Failing TB treatment with positive smear or culture after three months of standard treatment
Close contact with drug resistant TB case
Newly diagnosed with MDRTB within the last 30 days
Previously diagnosed with MDRTB and failed TB treatment with positive sputum or culture after three months of standard MDRTB treatment
Exclusion Criteria
Participants will be excluded from the study if informed consent is not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of Xpert MTB/XDR assay for INH and Second Line resistance detection as a rapid diagnostic modality for XDRTBTimepoint: Diagnostic accuracy of Xpert MTB/XDR assay for INH and Second Line resistance detection as a rapid diagnostic modality for XDRTB at the end of study
- Secondary Outcome Measures
Name Time Method Direct performance versus performance on cultured samples <br/ ><br>Performance between sites <br/ ><br>Performance by smear result <br/ ><br>Performance by Gene target <br/ ><br>Performance compared to Hain MTBDRplus/sl <br/ ><br>Performance by patient HIV status <br/ ><br>Performance by patient pre-treatment status <br/ ><br>Performance as reflex test to Ultra or MTB/RIF assayTimepoint: 9 months