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Validation and feasibility study of Swaasa AI platform for detecting TB.

Validation and operational feasibility study of Swaasa AI platform for detecting likely presence of Pulmonary Tuberculosis(PTB) among patients presenting with cough in India. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065058
Enrollment
7000
Registered
2024-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: NIL: NIL

Sponsors

Indian Health Fund (IHF) and ACT
Lead Sponsor
Salcit Technologies Private Limited
Collaborator

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

MeasureTime frame
To assess the feasibility of Swaasa AI Platform in screening pulmonary tuberculosis at various levels of healthcare.Timepoint: 6 months

Primary

MeasureTime 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

Public ContactNarayana Rao Sripada

AIIMS - All India Institute of Medical Sciences

rakeshkumar@aiims.edu9810672953

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026