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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1926 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-12

Study Completion Date

2020-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TB-CAPT CORE Truenat Trial

NCT04568954

Tuberculosis Diagnoses Disease

COMPLETED NA

Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)

NCT05405296

TB COVID-19

ACTIVE_NOT_RECRUITING

Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB

NCT03350048

Pulmonary Tuberculosis

COMPLETED

Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB

NCT04752592

Tuberculosis, Pulmonary

COMPLETED NA

DIAgnostics for Multidrug Resistant Tuberculosis in Africa

NCT03303963

Tuberculosis, Multidrug-Resistant

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis, Pulmonary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case Detection Group

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

Truenat MTB

Intervention Type DIAGNOSTIC_TEST

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.

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).

Truenat MTB

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Truenat MTB Plus Truenat MTB-RIF Dx

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No