Validation and feasibility study of Swaasa AI platform for detecting TB.
- Conditions
- Health Condition 1: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2024/04/065058
- Lead Sponsor
- Indian Health Fund (IHF) and ACT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
For Phase 1:
Inclusion criteria for TB patients:
1.Age of 6 years and above
2.Have cough for 1 week or more
3.Diagnosed with tuberculosis (new or within 7 days of starting treatment) at study sites.
Inclusion criteria for non-TB patients:
1. Age more than 6 years
2. Patients in whom diagnosis of TB has been ruled out using NTEP protocol.
In the non-TB group, a mix of patients with chronic lung disease, and normal subjects will be included.
For Phase 2:
1. Registered in the OPD of CRHSP, Ballabgarh
2. Have cough for two weeks or more.
For Phase 1:
1.Patients in whom cough as a symptom is not present.
2.Pregnant women
3.Medical conditions in which coughing could be detrimental.
For Phase 2:
1.Already been diagnosed with pulmonary tuberculosis and is taking anti-tuberculosis medication for more than 15 days.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To estimate sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios of Swaasa AI platform to diagnose pulmonary tuberculosis among patients presenting with cough with diagnosis of pulmonary tuberculosis as per NTEP protocol as gold standard in India. <br/ ><br>2. To assess the performance of Swaasa AI platform to diagnose pulmonary tuberculosis in the clinical setting.Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method To assess the feasibility of Swaasa AI Platform in screening pulmonary tuberculosis at various levels of healthcare.Timepoint: 6 months