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CTRI Number  CTRI/2019/02/017672 [Registered on: 14/02/2019] Trial Registered Prospectively
Last Modified On: 11/02/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Clinical validation of Software 
Study Design  Other 
Public Title of Study   Research study to screen patients with TB of the lung using cough samples collected through a device 
Scientific Title of Study   Multicentric study to evaluate the efficacy of TimBresoftware as compared to standard screening modalities in subjects clinically suspected of pulmonary tuberculosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alben Sigamani 
Designation  Group Head - Clinical Reseach 
Affiliation  Narayana Health Hospitals 
Address  Department of Clinical Research # 258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore

Bangalore Rural
KARNATAKA
560099
India 
Phone    
Fax    
Email  alben.sigamani.dr@narayanahealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alben Sigamani 
Designation  Group Head - Clinical Reseach 
Affiliation  Narayana Health Hospitals 
Address  Department of Clinical Research # 258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore

Bangalore Rural
KARNATAKA
560099
India 
Phone    
Fax    
Email  alben.sigamani.dr@narayanahealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr Vikneshwaran 
Designation  Junior Consultant - Clinical Research 
Affiliation  Mazumdar Shaw Medical College, a unit of Narayana Hrudayalaya Ltd 
Address  Department of Clinical Research # 258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore

Bangalore Rural
KARNATAKA
560099
India 
Phone  9787649182  
Fax    
Email  vikneswaran.g.dr@narayanahealth.org  
 
Source of Monetary or Material Support  
Docturnal Pvt Ltd, T-Hub building, Gachibowli, Hyderabad - 500045 
 
Primary Sponsor  
Name  Docturnal Pvt Ltd 
Address  T-Hub Building, Gachibowli Hyderabad, IN - 500045 
Type of Sponsor  Other [Company] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alben Sigamani  Mazumdhar Shaw Medical Center  Department of Clinical Research, General Medicine, and Pulmonology # 258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore Rural
KARNATAKA 
8884431444

alben.sigamani.dr@narayanahealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Medical Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Aged above 18 years  
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders, (2) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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 NPV  
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
. 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 characteristics  
3 months 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/02/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Tuberculosis (TB)is one of the oldest known disease to affect humans caused by Mycobacterium tuberculosis usually affecting the lungs although other organs can also be involved. (1) Pulmonary tuberculosisis a global heath burden affecting predominantly low and middle income countries. TB is one of the top 10 leading causes of death and the leading cause from a single infectious agent. (2) According to WHO database 2017, 1 million children became ill with TB and another 230000 children died of TB. Death due to TB was estimated to be around 1.3 million among HIV negative individuals 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 in 1960s showed that the spread of droplet nuclei was more during cough than by talking or singing. (5) Since then there was a number of studies focusing on the cough characteristics such as cough frequency, diurnal variation etc. Proano et al (6) studied the dynamics of cough frequency in 64 adults undergoing treatment for pulmonary TB using a semi-automated ambulatory monitor Cayetano Cough Monitor. The study showed that coughs were more frequent in daytime. Two weeks of antitubercular therapy (ATT) reduced cough frequency and achieved culture conversion in one third of patients.The Cavetano Cough Monitor was validated in patients with TB and showed a sensitivity of 75.5%

Early diagnosis of pulmonary TB in an individual is crucial for TB control because it helps in early initiation of treatment as well as reduce further spread in the community. Chest X ray though useful in diagnosis has limitations due to lack of specificity and presence of atypical findings that can mimic other conditions. Definitive diagnosis depends on recovery of the organism in culture or identification using DNA or RNA amplification techniques

TimBre is a Non-Invasive & Point of Care Solution from Docturnal that screens for Pulmonary Tuberculosis Screening using a Microphone Array that is 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 is obtained to avoid the bacilli spread to the next suspect/patient. It supports both USB & battery & an additional connector connects to Mobile Phone Jack to the Line in jack of the Microphone Array. This can also be replaced by a USB 2.0 cable. Optionally a tripod is available as needed. 

 
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