Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test

Completed

• Conditions: Tuberculosis, Pulmonary

• Registration Number: NCT03712709
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief Summary

Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2019-03-12
• Primary Completion: 2020-07-09
• Study Completion: 2020-07-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1926

Inclusion Criteria

Case Detection Group:

• Age 18 years or above
• Clinical suspicion of pulmonary TB (including cough ≥2 week and at least 1 other symptom typical of TB);
• Willingness to provide 3-4 sputum specimens at enrolment;
• Willingness to have a trial follow-up visit approximately 2 months after enrolment;
• Provision of informed consent.

Drug Resistant TB Group:

In addition to the criteria of the Case Detection Group, participants should also meet the following conditions:

• Non-converting pulmonary TB cases (category I and category II failures)

Exclusion Criteria

Case Detection Group:

• Receipt of any dose of TB treatment within 60 days prior to enrolment (even if within last two days only).

Drug Resistant TB Group:

• Receipt of any dose of MDR-TB treatment within 60 days prior to enrolment (even if within last two days only).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay	Day 1	Estimate diagnostic accuracy of the Truenat assays (MTB and MTB Plus) for Mycobacterium tuberculosis (MTB) detection among individuals undergoing evaluation for pulmonary TB, using a culture reference standard

Secondary Outcome Measures

Name	Time	Method
Time to TB detection and RIF resistance detection.	Day 1	Assess patient important outcomes, including time to detection of TB and RIF resistance.
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF	Day 1	Compare the diagnostic accuracy of the Truenat MTB-RIF Dx assay to that of Xpert MTB/RIF, using a reference standard of culture for TB diagnosis and phenotypic/genotypic DST for detection of RIF resistance.
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay	Day 1	Estimate diagnostic accuracy of the Truenat MTB-RIF Dx assay for RIF resistance detection among individuals undergoing evaluation for pulmonary TB and DR TB, using phenotypic/genotypic drug susceptibility testing (DST) .
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay compared to Xpert MTB/RIF	Day 1	Compare the diagnostic accuracy of the Truenat assays (MTB and MTB Plus) to that of Xpert MTB/RIF, using a reference standard of culture for TB diagnosis and phenotypic/genotypic DST for detection of RIF resistance.

Trial Locations

Locations (4)

EPHI; 🇪🇹 Addis Ababa, Ethiopia

State TB and Demonstration Center; 🇮🇳 Ahmedabad, India

NIRT; 🇮🇳 Chennai, India

PD Hinduja Hospital; 🇮🇳 Mumbai, India