| CTRI Number |
CTRI/2022/12/047990 [Registered on: 08/12/2022] Trial Registered Prospectively |
| Last Modified On: |
08/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
To study the performance of Truenat machine to detect COVID-19 and TB simultaneously from the same sample |
|
Scientific Title of Study
|
Performance evaluation of the Molbio Diagnostics Truenatâ„¢ MTB Plus/COVID-19 for TB and COVID-19 case detection using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol version number v 1 0 dated 07/12/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjuraj Purohit |
| Designation |
Professor and head |
| Affiliation |
R. D. Gardi Medical College |
| Address |
Professor and Head
Department of Pathology
R. D. Gardi Medical College
Ujjain, (M P), India, 456006
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9425093572 |
| Fax |
|
| Email |
manjuraj.purohit64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjuraj Purohit |
| Designation |
Professor and head |
| Affiliation |
R. D. Gardi Medical College |
| Address |
Professor and Head
Department of Pathology
R. D. Gardi Medical College
Ujjain, (M P), India, 456006
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9425093572 |
| Fax |
|
| Email |
manjuraj.purohit64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjuraj Purohit |
| Designation |
Professor and head |
| Affiliation |
R. D. Gardi Medical College |
| Address |
Professor and Head
Department of Pathology
R. D. Gardi Medical College
Ujjain, (M P), India, 456006
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9425093572 |
| Fax |
|
| Email |
manjuraj.purohit64@gmail.com |
|
|
Source of Monetary or Material Support
|
| FIND Geneva,
Foundation for Innovative New Diagnostics (FIND) Campus Biotech9 Chemin des Mines 1202 Geneva |
|
|
Primary Sponsor
|
| Name |
FIND India |
| Address |
Flat No. 8, 9th Floor, Vijaya Building, 17, Barakhamba Road, New Delhi-110001 |
| Type of Sponsor |
Other [Non-profit organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Peru
South Africa
Uganda
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjuraj Purohit |
R. D. Gardi Medical College |
Central Research Laboratory, Department of Pathology,
R. D. Gardi Medical College
Ujjain, (M P), India, 456006
Ujjain
MADHYA PRADESH |
09425093572
manjuraj.purohit64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult (>_ 18 years) and
2. Able to provide written informed consent in their chosen language; and
3. Self-report at least one or more symptoms suggestive of pulmonary TB; and
4. Willing to return for a day 2 visit
5. Willing to provide oral swab samples for biobanking |
|
| ExclusionCriteria |
| Details |
1. Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
2. Any anti-TB treatment within 60 days prior to enrolment (not current episode)
3. Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1
4. Unable to provide all study samples before starting the 3rd dose of anti-TB treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Point estimates of sensitivity and specificity of Truenatâ„¢ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRS |
3-24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Point estimates of sensitivity & specificity of truenat MTB Plus/COVID-19 with 95% confidence intervals, using the defined covid 19 country approved rt pcr covid 19 assay |
3-24 months |
| Analysis of survey responses using proportions and linkert scale averages |
3-24 months |
| Estimates of the proportion of presumptive tb patients with covid 19 confirmed by MRS (expressed as a percentage) |
3-24 months |
| Estimates of the proportion of TB patients (confirmed by MRS) with COVID 19 confirmed by MRS (expressed as a percentage) |
3-24 months |
| Point estimates of sensitivity & specificity of Truenat MTB Plus/COVID-19 multiplex for TB detection compared to Xpert Ultra among presumptive TB patients using a MRS |
3-24 months |
|
|
Target Sample Size
|
Total Sample Size="1480"
Sample Size from India="370"
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)
|
09/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/08/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be the joint responsibility of Sponsor and Investigator. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tuberculosis (TB) remains a major public health problem globally, compounded by the ongoing Covid-19 pandemic.
Truenat® MTB Plus/SARS-CoV2 multiplex, can detect both diseases. Goal is to determine the performance of Truenat® MTB Plus/SARS-CoV2 multiplex for TB and Covid-19 case detection using prospectively collected swabs and sputum samples. Data generated will be presented to WHO for review
|