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
|
|
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
|
|
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. |