diagnosis, differentiation of patients/subjects with active or latent tuberculosis infection and non-infected patients/subjects A15
Conditions
Interventions
Group 1: Patients with active TB disease (clinically confirmed): 330-480
study specific measurements: RTT-Verfahren, IGRA-test, questionnaire
Group 2: Patients/ Subjects with latent TB infection
Sponsors
Mikrogen GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - At least 18 years of age - Known TB infection status (i.e. active disease, latent infection or non-infected with M. tuberculosis) or TB infection status is planned to be determined during study duration - Given blood donation compatibility - Written informed consent
Exclusion criteria
Exclusion criteria: - Known to be positive for HIV or chronic hepatitis infection - Presence of any form of substance abuse, psychiatric disorder or condition that in the opinion of the investigator may impair the communication with the investigator or the patient’s compliance - More than 7 days of treatment with any antituberculous drug in patients with suspect for active TB disease - If not intended for tracking of therapeutic process: o patients under immunosuppressive therapy (biologics or >10mg steroids) within the last 2 months - If intended for tracking of therapeutic process: o Patients with TB infection under Rifampicin treatment already started prior to the planned visit 1 o Latent and non-infected patients under immunosuppressive therapy (biologics or >10mg steroid) already started prior to the planned visit 1 - in Austria only: pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimization of RTT method (in terms of practicability and robustness i.e. minimizing the impact of external influences and maximizing user-friendliness) by analyzing the following parameters or procedure steps, respectively: - Sample quality - Stimulation - Component testing - Read-out In addition, comparability and resilience in regard to technical parameters will be taken into account after fixing of standard RTT-TB procedure steps (i.e. stimulation / harvesting and sample processing / read-out). For individual questions: - Optimization: Signal increase by a factor of at least 1.5 - Consistency: Signal variation by a factor of less than 1.5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of potential influencing factors such as Rifampicin-therapy (=“TB treatment“) or immunosuppressive therapy (only patients intended for therapy due to an underlying disease such as Rheumatoid Arthritis). For these analyses, a small cohort (of at least 15 patients per experiment) will be included for “tracking of therapy process”. Only valid from version 06.00: In addition to the above defined group of patients with follow-up during treatment, a defined cohort of 50-60 patients already treated when arriving at the study site will be allowed to be included into the study. Treatment may not exceed seven days. The treated group will be analysed in a joint and separate evaluation from the untreated group to investigate possible differences: - No influence by treatment: Consistent signal (variation by a factor of less than 1.5) with and without treatment or comparable sensitivities in Rif-treated vs. Rif-untreated patients, respectively - Influence by treatment: Signal decrease or increase of at least 1.5 or distinct sensitivities in Rif-treated vs. Rif-untreated patients, respectively | — |
Countries
Austria, Germany
Contacts
Public ContactMichelle Modjesch
Mirkogen GmbH Betriebsstätte Regensburg
Outcome results
None listed