Tuberculosis, Non-tuberculous mycobacterial disease A15 A31
Conditions
Interventions
Group 1: In Arm 1, a one-time collection of additional blood volume will be performed in patients with non-tuberculous mycobacterial (NTM) infection during a routine blood draw (i.e., no additional ve
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: Tuberculosis infection, NTM infection, or a high-risk profile for either of the two aforementioned conditions
Exclusion criteria
Exclusion criteria: Lack of capacity to consent, pregnancy, and other medical reasons contraindicating blood collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in Subproject 1 is the test result of the novel NTM ELISpot assay. A one-time isolation of peripheral blood mononuclear cells (PBMCs) from whole blood will be performed, followed by ELISpot analysis using the novel test for NTMs, multiplex ELISA, and gene expression analyses for the investigation of immunological markers at the Institute of Immunology at Leipzig University and at Charité University Hospital. The primary endpoint in Subproject 2 is the detection of Mycobacterium tuberculosis on the membrane of the filter system. A one-time PCR analysis using the GeneXpert system will be conducted at the National Reference Laboratory in Borstel. | — |
Countries
Ethiopia, Germany
Contacts
Public ContactMatthias Gröschel
Charité - Universitätsmedizin Berlin
Outcome results
None listed