Clinical trial NCT05405296: Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: TB
COVID-19
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 1480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study focuses on adults with presumptive TB. Study sites are selected to maximize the generalizability of evidence generated based on the following criteria: 1) TB incidence ≥100 per 100,000 population; 2) HIV prevalence; 3) ongoing community transmission of COVID-19; and 4) laboratory and clinical study infrastructure to support participant recruitment.

Location: the study will take place in 4different countries: South Africa, Uganda, Peru, India Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.

Brief summary: 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.

Detailed description: Adult patient with presumptive TB will be screened for inclusion at 4 geographically diverse participating centres in high TB burden countries. This will be the first large scale evaluation on prospectively collected fresh samples.

Telephonic follow-up visits at 2 weeks (for baseline COVID-19 negative patients) and 2 months (for all participants) after enrolment will help overcome the challenges of using MRS only. Follow-up will be conducted telephonically two weeks post-enrolment for participants who tested negative for COVID-19at enrolment to determine any change in status -this is intended to account for participants who may have tested 'early' for COVID-19at enrolment (false negative) but subsequently developed symptoms or tested COVID-19positive. Similarly, investigators will conduct a telephonic follow-up two months post-enrolment among all participants to determine if: 1) participants diagnosed with confirmed TB at enrolment were linked to treatment; and 2) assess if any new TB diagnoses were made.

This multi-center study will evaluate the performance of the Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex test using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB and collect alternative tongue swab samples for further research use. The data gathered from this study, will form part of the dossier to be submitted to WHO (world health organization) for review.

Eligibility criteria: 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.

Primary outcomes:
measure: Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19
timeFrame: 2 days
Secondary outcomes:
measure: Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR COVID-19
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: Estimate of the proportion of presumptive TB patients with COVID-19
timeFrame: 2 days
measure: Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19
timeFrame: 2 days
measure: Analysis of survey responses using proportions and Linkert scale averages
timeFrame: 2 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makarere University
Study officials:
References: