COVID-19 Clinical Trial
— Truenat COMBOOfficial title:
Performance Evaluation of the Molbio Diagnostics Truenat™MTB Plus/COVID-19for TB and COVID-19case Detection Using Prospectively Collected NP (Nasopharyngeal) Swabs and Sputum Samples From Participants With Symptoms Suggestive of TB
Verified date | January 2024 |
Source | Foundation for Innovative New Diagnostics, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective, multicentre study in which the accuracy of the Molbio Diagnostics Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex will be assessed for TB and COVID-19 case detection using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB. The overall study period is of 24 months which includes telephonic follow-up of the baseline COVID-19negative patients at 2 weeks and of all participants at 2 months.
Status | Active, not recruiting |
Enrollment | 1480 |
Est. completion date | September 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult (=18 years); and - Able to provide written informed consent in their chosen language; and - Self-report at least one or more symptoms suggestive of pulmonary TB*; and - Willing to return for a day 2 visit - Willing to provide oral swab samples for biobanking * cough =2 weeks, fever, night sweats or unintended weight-loss Exclusion Criteria: - Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment - Any anti-TB treatment within 60 days prior to enrolment (not current episode) - Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1 - Unable to provide all study samples before starting the 3rddose of anti-TB treatment. |
Country | Name | City | State |
---|---|---|---|
Uganda | Makarere University | Kampala |
Lead Sponsor | Collaborator |
---|---|
Foundation for Innovative New Diagnostics, Switzerland |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19 | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRS | 2 days | |
Secondary | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR COVID-19 | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR ( real time polymerase chain reaction) COVID-19 | 2 days | |
Secondary | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19multiplex for TB detection compared to Xpert Ultra among presumptive TB patients using a MRS | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19multiplex for TB detection compared to Xpert Ultra among presumptive TB patients using a MRS | 2 days | |
Secondary | Estimate of the proportion of presumptive TB patients with COVID-19 | Estimate of the proportion of presumptive TB patients with COVID-19 confirmed by country-approved RT-PCR Covid-19 assay) (expressed as a percentage) | 2 days | |
Secondary | Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19 | Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19(confirmed by country-approved RT-PCR Covid-19 assay) (expressed as a percentage) | 2 days | |
Secondary | Analysis of survey responses using proportions and Linkert scale averages | Analysis of survey responses using proportions and Linkert scale averages | 2 days |
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