To study the performance of Truenat machine to detect COVID-19 and TB simultaneously from the same sample

Not yet recruiting

• Conditions: Tuberculosis of lung, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2022/12/047990
• Lead Sponsor: FIND India

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-12
• Study Start: 2022-09-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 1480

Inclusion Criteria

• 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.

Exclusion Criteria

• Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment 2.
• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Analysis of survey responses using proportions and linkert scale averages	3-24 months
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
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

Trial Locations

Locations (1)

R. D. Gardi Medical College; 🇮🇳 Ujjain, MADHYA PRADESH, India

R. D. Gardi Medical College

🇮🇳Ujjain, MADHYA PRADESH, India

Dr Manjuraj Purohit

Principal investigator

09425093572

manjuraj.purohit64@gmail.com