Discovery of novel Interferon Gamma Release Assays andBiomarkers for the Diagnosis of Tuberculosis Disease and Infection - IGRA TB

Roche Diagnostics0 个研究点目标入组 120 人开始时间: 2023年8月30日最近更新: 2024年8月19日

适应症

试验速览

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•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

•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

发起方

Roche Diagnostics