Discovery of Novel Biomarkers for the Diagnosis of TB Disease - DisTB

Roche0 个研究点目标入组 360 人开始时间: 2023年8月9日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

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