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

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Tuberculosis, Pulmonary

Treatments: Diagnostic Test: Truenat MTB

Study type: Observational

Funder types: Other

Identifiers

NCT03712709

7212-03/2

Details and patient eligibility

About

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.

Enrollment: 1,926 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,926 participants in 2 patient groups

Case Detection Group

Description:

Clinical suspicion of pulmonary TB (including cough ≥2 week and at least 1 other symptom typical of TB). Only participants who have not received any form of TB treatment within the prior 60 days will be enrolled

Treatment:

Diagnostic Test: Truenat MTB

Drug Resistant TB Group

Description:

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).

Treatment:

Diagnostic Test: Truenat MTB