A15
Conditions
Interventions
Group 1: 1. Individuals with microbiologically confirmed pulmonary tuberculosis disease (Mycobacterium tuberculosis-confirmed)
a. Bacteriological confirmation obtained: requires MTB to be confirmed (c
past and present).
Group 4: 4. Individuals cured of TB disease after end of treatment (Post-TB)
a. Previous microbiological confirmation of TB disease
b. Treatment success marker: no sign/ symptoms of
Sponsors
Roche Diagnostics
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 Are currently receiving anti-TB drugs (V2) OR Previous TB diagnosis (non-MTB-infected) 3. Individuals exposed to and infected with MTB: Immunological evidence of infection with MTB (IGRA positive) AND No clinical signs for TB disease 4. Individuals with minimal risk of being exposed to MTB and/or no indication of exposure to MTB (presumed MTB-naïve): No known/reported TB contact (e.g. health workers) AND No rRisk of having been exposed to MTB (i.e., belonging to risk groups) AND Without immunological evidence of infection with MTB (IGRA negative; past and present) 5. Individuals cured of TB disease after end of treatment Successful treatment completion >6 and <12 months after previous confirmed TB disease prior to enrolment confirmed by physician AND 6 months without (self-) reported travel history to endemic regions AND Are currently receiving anti-TB drugs
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) 2. Patients 12 months prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint(s): AUC of all novel antigens (antigen concentrations) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint(s): Specificity as per statistical considerations | — |
Countries
Germany
Contacts
Public ContactMichael Hoelscher
Division of Infectious Diseases and Tropical Medicine
Outcome results
None listed