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

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ClinicalTrials.gov Identifier: NCT03712709
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
Burnet Institute
National Institute for Research in Tuberculosis, Chennai, India
Universidad Peruana Cayetano Heredia
Ethiopian Public Health Institute
PD Hinduja Hospital and Medical Research Centre, Mumbai, India
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Tuberculosis, Pulmonary Diagnostic Test: Truenat MTB

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Study Type : Observational
Estimated Enrollment : 1666 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
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
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.
Other Names:
  • Truenat MTB Plus
  • Truenat MTB-RIF Dx

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).
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.
Other Names:
  • Truenat MTB Plus
  • Truenat MTB-RIF Dx




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Participant sputum may be retained for future research on TB diagnostics


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from outpatient TB clinics at district or regional health facilities. Given the important role of the private sector in India, 1 private laboratory will be included in the trial which is an MDR reference hospital.

This is a multi-centre trial conducted in four countries: India, Peru, Papua New Guinea and Ethiopia. Countries were selected to be globally representative of the TB epidemic.

Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712709


Contacts
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Contact: Adam Penn-Nicholson, PhD +41 (22) 710 05 90 adam.penn-nicholson@finddx.org
Contact: Pamela Nabeta, MD +41 (22) 710 05 90 pamela.nabeta@finddx.org

Locations
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Ethiopia
EPHI Recruiting
Addis Ababa, Ethiopia
Contact: Abyot Meaza         
India
State TB and Demonstration Center Recruiting
Ahmedabad, India
Contact: Pranav Patel         
NIRT Recruiting
Chennai, India
Contact: N S Gomathi         
PD Hinduja Hospital Recruiting
Mumbai, India
Contact: Camilla Rodrigues         
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
Burnet Institute
National Institute for Research in Tuberculosis, Chennai, India
Universidad Peruana Cayetano Heredia
Ethiopian Public Health Institute
PD Hinduja Hospital and Medical Research Centre, Mumbai, India
  Study Documents (Full-Text)

Documents provided by Foundation for Innovative New Diagnostics, Switzerland:
Study Protocol  [PDF] September 7, 2018


Publications of Results:
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03712709     History of Changes
Other Study ID Numbers: 7212-03/2
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections