Development of an immunological IL2whole blood test for the diagnosis of active tuberculosis

Development of an immunological IL2whole blood test for the diagnosis of active tuberculosis - Novel whole blood test for Active Tuberculosis (TB)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035658

Enrollment

250

Registered

2025-01-03

Start date

2025-03-17

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Group 1: It is not an intervention study In this study, whole blood of study participants shall be induced overnight with recombinant antigen alanine dehydrogenase of the tuberculosis causative agent

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants are exclusively informed and consenting persons who are routinely examined for a potential tuberculosis infection at Städtisches Klinikum Braunschweig. There should be no participants from specially protected groups.

Exclusion criteria

Exclusion criteria: Minors or persons unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
To investigate whether with the use of the new active-tuberculosis test (to be developed) measurable concentrations of IL2 in whole blood are present	—

Secondary

Measure	Time frame
To investigate whether with the use of the new active tuberculosis tests (to be developed) sensitivity and specificity of 90-95 % can be achieved	—

Countries

Germany

Contacts

Public ContactThomas Bitter

Städtisches Klinikum Braunschweig gGmbH, Klinik für Pneumologie und Beatmungsmedizin (Medizinische Klinik VII)

t.bitter@skbs.de+49 531 595 4530

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026