Evaluation of the Performance of a new test for the diagnosis of high risk tuberculosis.
Phase 3
Completed
- Registration Number
- CTRI/2020/06/026021
- Lead Sponsor
- bioMerieux
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 37
Inclusion Criteria
1. A person who meets at least one of the criteria below, classifying him/her as being at increased risk for M. tuberculosis infection (and therefore LTBI) and/or for progression to active TB
Exclusion Criteria
1. A person who has or has had active TB.
2. A person who has received treatment for active TB or LTBI
3. A person who has received an anti-TNF treatment within the previous 3 months
4. A person who has had a TST in the previous 12 weeks
5. Pregnant women (self-reported)
6. A person who has been diagnosed with a NTM infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive and negative percent agreements for the VIDAS TB IGRA assay.Timepoint: After 5 months of recruitment. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable