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Clinical Trials/DRKS00030861
DRKS00030861
Recruiting
Not Applicable

Collection of blood samples for research and development of an IP-10 TB-CLIA-Assay - TB-CLIA-1

R-Biopharm AG0 sites200 target enrollmentMay 26, 2023

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.

Registry
who.int
Start Date
May 26, 2023
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

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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