Health Condition 1: A191- Acute miliary tuberculosis of multiple sites Health Condition 2: A183- Tuberculosis of intestines, peritoneum and mesenteric glands Health Condition 3: A154- Tuberculosis of intrathoracic lymph nodes Health Condition 4: A150- Tuberculosis of lung Health Condition 5: A188- Tuberculosis of other specified organs
Conditions
Interventions
Intervention1: Point of Care Lung and abdominal USG: This is a diagnostic intervention (like a regular Ultrasound test) which will take maximum 30 minutes. The treatment duration is as decided by the
Sponsors
German Infectious Disease Research Center DZIF
Eligibility
Inclusion criteria
Inclusion criteria: - 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): o Current cough of 2 weeks or of any duration in PLHIV o Night sweats o Fever o Weight 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate of sensitivity and specificity of the FASH-protocol with 95% confidence intervals (CI) for TB against MRS, eMRS and CRS Estimate of sensitivity and specificity of various lung ultrasound findings with 95% CI for TB against MRS, eMRS and CRS 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 treatment) . | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany, India
Contacts
Public ContactDr Kavitha Saravu
Kasturba Medical College, Manipal Academy of Higher education, Manipal
Outcome results
None listed