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

Tuberculosis, Pulmonary Clinical Trial

Official title:

Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712709
• Other study ID #: 7212-03/2
• Status: Completed
• Start date: March 12, 2019
• Est. completion date: July 9, 2020

Study information

• Verified date: August 2020
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1926
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Diagnostic Test:
• Truenat MTB
The Truenat MTB (including both MTB and MTB Plus) and the MTB-RIF Dx reflex assays (Molbio Diagnostics; Bangalore, India) utilize chip-based real-time micro-PCR for detection of tuberculosis (TB) and rifampicin (RIF) resistance from DNA extracted (on a separate device) from sputum samples. The Truenat MTB assay targets a single copy gene while the MTB Plus assay combines detection of a single copy and multi-copy gene.

Locations

Country	Name	City	State
Ethiopia	EPHI	Addis Ababa
India	State TB and Demonstration Center	Ahmedabad
India	NIRT	Chennai
India	PD Hinduja Hospital	Mumbai

Sponsors (6)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Burnet Institute, Ethiopian Public Health Institute, National Institute for Research in Tuberculosis, Chennai, India, PD Hinduja Hospital and Medical Research Centre, Mumbai, India, Universidad Peruana Cayetano Heredia

Countries where clinical trial is conducted

Ethiopia,  India, 

References & Publications (2)

Nikam C, Jagannath M, Narayanan MM, Ramanabhiraman V, Kazi M, Shetty A, Rodrigues C. Rapid diagnosis of Mycobacterium tuberculosis with Truenat MTB: a near-care approach. PLoS One. 2013;8(1):e51121. doi: 10.1371/journal.pone.0051121. Epub 2013 Jan 21. — View Citation

Nikam C, Kazi M, Nair C, Jaggannath M, M M, R V, Shetty A, Rodrigues C. Evaluation of the Indian TrueNAT micro RT-PCR device with GeneXpert for case detection of pulmonary tuberculosis. Int J Mycobacteriol. 2014 Sep;3(3):205-10. doi: 10.1016/j.ijmyco.2014 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay	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	Day 1
Secondary	Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay	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) .	Day 1
Secondary	Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay compared to Xpert MTB/RIF	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.	Day 1
Secondary	Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF	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.	Day 1
Secondary	Time to TB detection and RIF resistance detection.	Assess patient important outcomes, including time to detection of TB and RIF resistance.	Day 1