Assessment of Innovative Diagnostics and Algorithms for Early and Sensitive Detection of Acute and Incident TB in Adults and Children

Assessment of Innovative Diagnostics and Algorithms for Early and Sensitive Detection of Acute and Incident TB in Adults and Children - AIDA-TB

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012598

Enrollment

750

Registered

2017-06-16

Start date

2017-07-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Acute and Incident Tuberculosis A15

Interventions

Group 1: At the screening visit the new test performances (antigen detection tests, Cellular immunresponse assays nucleinacid amplification tests, host biomarker validation, host RNA signatur validati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed written consent or witnessed oral consent. In case of minors, signed consent is to be obtained from the legal guardian. 2. With a suspicion of active or latent TB

Exclusion criteria

Exclusion criteria: 1. Critical condition (if study procedures seems like an undue risk to patient’s life) 2. Body weight is less than 2 kg 3. Are currently receiving anti - TB drug(s): more than three daily doses given since treatment start before first study blood draw 4. Have received more than 30 days’ doses of TB drugs in the last three months, with the last dose less than one month ago

Design outcomes

Primary

Measure	Time frame
The aim is to evaluate the sensitivity and specificity plus the of the positive and negative predictive values of new tests (antigen detection tests, cellular immunresponse assays, nucleinacid amplification tests, host biomaker validation, host RNA signature validation) in comparision to the current gold standard (microbiological detection)	—

Secondary

Measure	Time frame
- Assess treat and test hypothesis: TB can be ruled out by a negative urine test, the sensitivity of which is enhanced early in treatment - DRS (Disease Risk Score) and COR (Prognostic Correlate of Risk) can accurately distinguish TB from other diseases (and LTBI) - Development of active disease (incident TB) can be predicted by new, highly sensitive diagnostics including TAM TB and RNA – based approaches.	—

Measure

Time frame

- Assess treat and test hypothesis: TB can be ruled out by a negative urine test, the sensitivity of which is enhanced early in treatment - DRS (Disease Risk Score) and COR (Prognostic Correlate of Risk) can accurately distinguish TB from other diseases (and LTBI) - Development of active disease (incident TB) can be predicted by new, highly sensitive diagnostics including TAM TB and RNA – based approaches.

—

Countries

Germany

Contacts

Public ContactNorbert Heinrich

Abteilung für Infektions- und Tropenmedizin, Klinikum der Universität München (LMU)

München+49 89 2180 17605/17603

Outcome results

None listed

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