AbdominaL and Lung Point-of-Care UltraSound for Tuberculosis in Germany and India
- Conditions
- Health Condition 1: A191- Acute miliary tuberculosis of multiple sitesHealth Condition 2: A183- Tuberculosis of intestines, peritoneum and mesenteric glandsHealth Condition 3: A154- Tuberculosis of intrathoracic lymph nodesHealth Condition 4: A150- Tuberculosis of lungHealth Condition 5: A188- Tuberculosis of other specified organs
- Registration Number
- CTRI/2021/03/032094
- Lead Sponsor
- German Infectious Disease Research Center DZIF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
patients aged 16 years or older
-presenting with symptoms compatible with pulmonary TB (PTB) and/or extra-pulmonary (EPTB): 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
-in Germany another group to enrol will be: patients referred to the study sites because TB is presumed due to radiological, histopathological evidence and where a further TB workup is planned (recognizing the selection bias in the analysis plan)
-Willingness to have a study follow-up visit at 2-3 months after enrolment (e.g. not planning to relocate). Sonographic follow-up (primary objective 3):
-For patients with sonographic findings of TB disease who are treated with anti-TB drugs and who give consent for follow-up ultrasound, US will be repeated at defined timepoints
-no consent given
-already confirmed diagnosis of TB (by sputum microscopy, culture, PCR)
-on anti-tuberculous treatment for more than 24 hours
-on anti-tuberculous treatment within the past 60 days
-on preventive therapy for TB infection within the past 6 months
-Patients presenting with presumed peripheral lymph node TB
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate of sensitivity and specificity of the FASH-protocol with 95% confidence intervals (CI) for TB against MRS, eMRS and CRS <br/ ><br> <br/ ><br>Estimate of sensitivity and specificity of various lung ultrasound findings with 95% CI for TB against MRS, eMRS and CRS <br/ ><br> <br/ ><br>Description of TB-associated sonographic findings during therapy with ranges of time to resolution (median, inter-quartile ranges), size reduction and compared to patients with therapy failureTimepoint: At baseline before the treatment, after 1, 2, 4, 6 months of treatment <br/ ><br>treatment) .
- Secondary Outcome Measures
Name Time Method Description of TB-associated sonographic findings during therapy with ranges of time to resolution (median, inter-quartile ranges), size reduction and compared to patients with therapy failureTimepoint: POC USG done at 1, 2, 4, 6 months of anti-tuberculous treatment;Sensitivity and specificity of AI-interpretation of POC-US with 95% CI against an expert interpretation and separately against MRS, eMRS and CRS as reference standardTimepoint: POCUS USG done at admission/ within 24 hours of TB diagnosis.