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

Not yet recruiting

Conditions: Aged above 18 years
Other specified respiratory disorders, (2) ICD-10 Condition: A150||Tuberculosis of lung,

Registration Number: CTRI/2019/02/017672

Lead Sponsor: Docturnal Pvt Ltd

Brief Summary: Tuberculosis (TB)is one of the oldestknown disease to affect humans caused by Mycobacterium tuberculosis usuallyaffecting the lungs although other organs can also be involved. (1) Pulmonarytuberculosisis a global heath burden affecting predominantly low and middleincome countries. TB is one of the top 10 leading causes of death and theleading cause from a single infectious agent. (2) According to WHO database2017, 1 million children became ill with TB and another 230000 children died ofTB. Death due to TB was estimated to be around 1.3 million among HIV negativeindividuals with an additional 3 lakhs death from HIV positive individuals (3)The disease mainly spreads through airway spread of droplet nuclei from cough.

A series of experiment conducted in1960s showed that the spread of droplet nuclei was more during cough than bytalking or singing. (5) Since then there was a number of studies focusing onthe cough characteristics such as cough frequency, diurnal variation etc. Proanoet al (6) studied the dynamics of cough frequency in 64 adults undergoingtreatment for pulmonary TB using a semi-automated ambulatory monitor Cayetano Cough Monitor. The study showed that coughs were more frequent in daytime. Two weeksof antitubercular therapy (ATT) reduced cough frequency and achieved cultureconversion in one third of patients.The Cavetano Cough Monitor was validated inpatients with TB and showed a sensitivity of 75.5%

Early diagnosis of pulmonary TB in an individual is crucial for TBcontrol because it helps in early initiation of treatment as well as reducefurther spread in the community. Chest X ray though useful in diagnosis haslimitations due to lack of specificity and presence of atypical findings thatcan mimic other conditions. Definitive diagnosis depends on recovery of theorganism in culture or identification using DNA or RNA amplification techniques

TimBre is a Non-Invasive & Point of Care Solution from Docturnalthat screens for Pulmonary Tuberculosis Screening using a Microphone Array thatis connected to a Mobile Phone RunningTimBre App.The device is a XY Microphone Array that comes with a filter(pop/wind) which needs to be replaced after a positively screened result isobtained to avoid the bacilli spread to the next suspect/patient. It supportsboth USB & battery & an additional connector connects to Mobile PhoneJack to the Line in jack of the Microphone Array. This can also be replaced bya USB 2.0 cable. Optionally a tripod is available as needed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 1500

Inclusion Criteria

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.
Who are willing to give written informed consent and comply with study related visit and procedure.

Exclusion Criteria

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

Secondary Outcome Measures

Name	Time	Method
. 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

Trial Locations

Locations (1): Mazumdhar Shaw Medical Center
🇮🇳
Rural, KARNATAKA, India
Mazumdhar Shaw Medical Center
🇮🇳Rural, KARNATAKA, India
Dr Alben Sigamani
Principal investigator
8884431444
alben.sigamani.dr@narayanahealth.org