Research study to screen patients with TB of the lung using cough samples collected through a device
Not Applicable
- Conditions
- Health Condition 1: J988- Other specified respiratory disordersHealth Condition 2: A150- Tuberculosis of lung
- Registration Number
- CTRI/2019/02/017672
- Lead Sponsor
- Docturnal Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess non-inferiority of sensitivity of TimBre software to not more than 10% of the sensitivity of standard screening modalities <br/ ><br>2. Evaluate the diagnostic performance of TimBre with standard screening modalities as measured by sensitivity, specificity, PPV and NPVTimepoint: 3 months
- Secondary Outcome Measures
Name Time Method . To study the influence of patient characteristics on diagnostic accuracy of TimBre software. <br/ ><br>2. To study the efficacy of TimBre software in differentiating drug sensitive cases from drug resistant TB cases <br/ ><br>3. To study the correlation of sputum conversion at the end of 3 months with cough characteristicsTimepoint: 3 months