A15
Conditions
Interventions
Group 1: Individuals with microbiologically confirmed pulmonary Tuberculosis disease (mycobacterium tuberculosis-confirmed). Blood, urine and saliva samples will be collected.
Group 2: Individuals wit
Sponsors
Roche
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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 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
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 12 months prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactMichael Hoelscher
LMU Klinikum
Outcome results
None listed