Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To assess the feasibility of Swaasa AI Platform in screening pulmonary tuberculosis at various levels of healthcare.Timepoint: 6 months | — |
Primary
| Measure | Time frame |
|---|---|
| 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. 2. To assess the performance of Swaasa AI platform to diagnose pulmonary tuberculosis in the clinical setting.Timepoint: 6 months | — |
Countries
India
Contacts
AIIMS - All India Institute of Medical Sciences