Discovery of novel Interferon Gamma Release Assays andBiomarkers for the Diagnosis of Tuberculosis Disease and Infectio

Recruiting

• Conditions: A15; Respiratory tuberculosis, bacteriologically and histologically confirmed

• Registration Number: DRKS00032592
• Lead Sponsor: Roche Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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

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 <18 years of age
3.People living with HIV or receiving any immune-modulating treatment
4.Pregnant women
5.Individuals with extrapulmonary TB
Specifically for respective groups:
1.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 (V1) OR
Previous TB diagnosis (non-MTB-infected)
2.Individuals exposed to and infected with MTB:
No immunological evidence of infection with MTB (IGRA positive) AND
No clinical signs for TB disease
3.Individuals with minimal risk of being exposed to MTB and/or no indication of exposure to MTB (presumed MTB-naïve):
Known/reported TB contact (e.g. health workers) AND
Risk of having been exposed to MTB (i.e., belonging to risk groups) AND
Without immunological evidence of infection with MTB (IGRA positive; past and present)

4.Individuals cured of TB disease after end of treatment
within 6 months (self-)reported travel history to endemic regions AND/OR
Are currently receiving anti-TB drugs AND/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
Primary Endpoint(s): AUC of all novel antigens (antigen concentrations)

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint(s): Specificity as per statistical considerations