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
- Conditions
- A18Tuberculosis of other organs
- Registration Number
- DRKS00026636
- Lead Sponsor
- Deutsches Zentrum für Infektionsforschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 710
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):
oCurrent cough of 2 weeks or of any duration in PLHIV
oNight sweats
oFever
oWeight 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
-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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method diagnostic accuracy of single ultrasound findings as compared to the reference standard
- Secondary Outcome Measures
Name Time Method evolution of ultrasound findings under anti-TB therapy