Discovery of Novel Biomarkers for the Diagnosis of TB Disease

Recruiting

Conditions: A15
Respiratory tuberculosis, bacteriologically and histologically confirmed

Registration Number: DRKS00032445

Lead Sponsor: Roche

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 360

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
Without immunological evidence of infection (IGRA negative; past and present) OR
5.Individuals cured of TB disease after end of treatment
Successful treatment completion >6 and <12 months prior to enrolment

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)
4.Individuals with extremely low risk of being exposed to or infected with MTB (presumed MTB-naïve):
Immunological evidence of infection with MTB OR
Reported TB contact OR
Risk of having been exposed to MTB (i.e., belonging to risk groups or travel history to TB high-burden countries)).
5.Individuals cured of TB disease after end of treatment
Are currently receiving anti-TB drug(s) OR
Successful treatment completion <6 and >12 months prior to enrolment

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and negative percent agreement to clinically determined active TB disease for down-selection of host and pathogen biomarkers or their combinations that fulfil triage or case detection.

Secondary Outcome Measures

Name	Time	Method
Down-selection of host or pathogen biomarkers or their combinations that may offer means of treatment monitoring which could be evaluated in a future prospective longitudinal study.