DRKS00032445
Recruiting
N/A
Discovery of Novel Biomarkers for the Diagnosis of TB Disease - DisTB
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- A15
- Sponsor
- Roche
- Enrollment
- 360
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All participants:
- •1\.Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any study specific activity.
- •Of the following, either criterions listed in 2\., 3\., 4\., OR 5\. have to be met:
- •2\.Individuals with microbiologically confirmed TB disease:
- •Following standard TB diagnostics with a confirmation of MTB via culture and/or PCR OR
- •3\.Individuals exposed to and infected with MTB:
- •Immunological evidence of infection with MTB (IGRA positive) AND
- •No clinical signs for TB disease OR
- •4\.Individuals with minimal risk of being exposed to MTB and/or no indication of exposure to MTB (presumed MTB\-naïve):
- •No known TB contact AND
Exclusion Criteria
- •All participants:
- •Participants will be excluded from study participation if they meet any of the following criteria:
- •1\.Critical condition (if study procedures seem like an undue risk to patient’s life)
- •Specifically for respective groups:
- •2\.Individuals with microbiologically confirmed TB disease:
- •Are currently receiving anti\-TB drugs OR
- •Previous TB diagnosis
- •3\.Individuals exposed to and infected with MTB:
- •Clinical suspicion of TB disease AND/OR
- •Positive microbiological testing for MTB (culture/PCR)
Outcomes
Primary Outcomes
Not specified
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