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Abdominal and thoracic ultrasound for the diagnosis of pulmonary and extra-pulmonary tuberculosis. Assessing the accuracy of point-of-care ultrasound for the diagnosis and therapy monitoring in patients with presumed tuberculosis in India and Germany

Abdominal and thoracic ultrasound for the diagnosis of pulmonary and extra-pulmonary tuberculosis. Assessing the accuracy of point-of-care ultrasound for the diagnosis and therapy monitoring in patients with presumed tuberculosis in India and Germany - ALL POC-US TB

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00026636
Enrollment
770
Registered
2021-09-15
Start date
2022-01-03
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

A18

Interventions

Group 1: Individuals with presumed TB disease undergo abdominal and thoracic ultrasound examination and results will be correlated with the reference standard (TB diagnosed?)

Sponsors

Deutsches Zentrum für Infektionsforschung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients aged 18 years or older - presenting with: clinical constellation compatible with pulmonary TB (PTB) and/or extra-pulmonary (EPTB) - AND TB presumed to be highly likely differential diagnosis due to clinical, radiological, laboratory information - AND at least one of the symptoms below suggestive of TB (as defined by WHO): o Current cough of 2 weeks or of any duration in PLHIV o Night sweats o Fever o Weight loss - Willingness to have a study follow-up visit at 2-3 months after enrolment (e.g. not planning to relocate). - if considered for follow-up study: willingness to have follow-up visits at 1, 2, 4, 6 months of anti-TB treatment

Exclusion criteria

Exclusion criteria: - no consent given - confirmed diagnosis of TB by sample >14 days ago (by sputum microscopy, culture, PCR) - on anti-tuberculous (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol, Quinolones) for more than 24 hours - on anti-tuberculous treatment (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol, Quinolones) in past 60 days - on preventive therapy for TB infection within the past 6 months

Design outcomes

Primary

MeasureTime frame
diagnostic accuracy of single ultrasound findings as compared to the reference standard

Secondary

MeasureTime frame
evolution of ultrasound findings under anti-TB therapy

Countries

Germany, India

Contacts

Public ContactClaudia Denkinger

Sektion klinische Tropenmedizin, UK Heidelberg

claudia.denkinger@uni-heidelberg.de062215622999

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 5, 2026