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Completed

NCT Number: NCT03712709

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

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.

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

EPHI, Addis Ababa, Ethiopia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Truenat MTB

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.

Other names: Truenat MTB Plus, Truenat MTB-RIF Dx

Primary outcomes

  1. Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay

    Time frame: 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 outcomes

  1. Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay

    Time frame: 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) .

  2. Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay compared to Xpert MTB/RIF

    Time frame: 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.

  3. Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF

    Time frame: 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.

  4. Time to TB detection and RIF resistance detection.

    Time frame: Day 1

    Assess patient important outcomes, including time to detection of TB and RIF resistance.

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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