Skip to main content
Clinical Trials/DRKS00032445
DRKS00032445
Recruiting
N/A

Discovery of Novel Biomarkers for the Diagnosis of TB Disease - DisTB

Roche0 sites360 target enrollmentAugust 9, 2023

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.

Registry
who.int
Start Date
August 9, 2023
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Roche

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

Similar Trials