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Research study to screen patients with TB of the lung using cough samples collected through a device

Multicentric study to evaluate the efficacy of TimBresoftware as compared to standard screening modalities in subjects clinically suspected of pulmonary tuberculosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/02/017672
Enrollment
1500
Registered
2019-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J988- Other specified respiratory disorders Health Condition 2: A150- Tuberculosis of lung

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Docturnal Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants of either gender above 18 years with symptoms suggestive of Pulmonary TB such as, Cough >2 weeks,Fever >2 weeks,Significant weight loss (more than 4.5 kg or 5% in 6 to 12 months), Haemoptysis, Any abnormalities in chest radiography. 2. Who are willing to give written informed consent and comply with study related visit and procedure

Exclusion criteria

Exclusion criteria: 1. Patients with extra pulmonary TB 2. Any psychological and/or pathological condition that would interfere with study participation in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
1. To assess non-inferiority of sensitivity of TimBre software to not more than 10% of the sensitivity of standard screening modalities 2. Evaluate the diagnostic performance of TimBre with standard screening modalities as measured by sensitivity, specificity, PPV and NPVTimepoint: 3 months

Secondary

MeasureTime frame
. To study the influence of patient characteristics on diagnostic accuracy of TimBre software. 2. To study the efficacy of TimBre software in differentiating drug sensitive cases from drug resistant TB cases 3. To study the correlation of sputum conversion at the end of 3 months with cough characteristicsTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Vikneshwaran

Narayana Health Hospitals

alben.sigamani.dr@narayanahealth.org

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026