DRKS00030861
Recruiting
Not Applicable
Collection of blood samples for research and development of an IP-10 TB-CLIA-Assay - TB-CLIA-1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- A15-A19
- Sponsor
- R-Biopharm AG
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General inclusion criteria:
- •Ability to understand and sign a written subject information and informed consent form
- •women and men over 18 years old
- •collection of the necessary volume of whole blood possible
- •Only for TB\-positive subjects
- •active or latent infection with tuberculosis
- •diagnosis of active tuberculosis: confirmed by clinical symptoms and molecular evidence (by PCR) or by cultural detection or by microscopic detection or by radiological examination
- •latent TB\-infection: confirmed by IGRA or Tuberkulin skin test
- •Only for TB\-negative subjects
- •no clinical or pathological test result or anamnestic data indicating active or latent infection with M. tuberculosis
Exclusion Criteria
- •pregnant or breastfeeding women
- •An event or finding, due to which the subject is not suitable for the participation in the study in the opinion of the principal investigator
Outcomes
Primary Outcomes
Not specified
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