Tuberculosis, PulmonaryNCT03712709
Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test
An observational study of Tuberculosis, Pulmonary, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Truenat MTB
- How many people
- 1,926 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Mar 2019to 9 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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)
Who cannot join
- 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 locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
India3 sites
State TB and Demonstration Center
Ahmedabad
NIRT
Chennai
PD Hinduja Hospital
Mumbai
About this study
Official title: Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
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.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Truenat MTB
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truenat MTBDiagnostic test
Also called Truenat MTB Plus, Truenat MTB-RIF Dx
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Truenat MTB | |
| 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). Receives: Diagnostic Test: Truenat MTB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (4)
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) .
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Time to TB detection and RIF resistance detection.
Assess patient important outcomes, including time to detection of TB and RIF resistance.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start12 Mar 2019
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712709
- Sponsor's protocol ID
- 7212-03/2
- Status last verified
- Aug 2020
- First submitted
- 27 Sep 2018
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23349670Nikam 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.2014.04.003. Epub 2014 Jun 2.
PubMed 26786489Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.
PubMed 40122135Penn-Nicholson A, Gomathi SN, Ugarte-Gil C, Meaza A, Lavu E, Patel P, Choudhury B, Rodrigues C, Chadha S, Kazi M, Mace A, Nabeta P, Boehme C, Gangakhedkar RR, Sarin S, Tesfaye E, Gotuzzo E, du Cros P, Tripathy S, Ruhwald M, Singh M, Denkinger CM, Schumacher SG; Truenat Trial Consortium; Members of the Truenat Trial Consortium:. A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays. Eur Respir J. 2021 Nov 4;58(5):2100526. doi: 10.1183/13993003.00526-2021. Print 2021 Oct.
PubMed 34049948Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.
PubMed 33616229
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
- ClinicalTrials.gov ID
- NCT03712709
- Acronym / sponsor ID
- 7212-03/2
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,926 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- 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
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Detection Group | – | Diagnostic Test: Truenat MTBClinical 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 |
| Drug Resistant TB Group | – | Diagnostic Test: Truenat MTBIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- Receipt of any dose of TB treatment within 60 days prior to enrolment (even if within last two days only).
- Receipt of any dose of MDR-TB treatment within 60 days prior to enrolment (even if within last two days only).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Truenat MTBAlso: Truenat MTB Plus, Truenat MTB-RIF DxThe 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. | Diagnostic test | Case Detection Group, Drug Resistant TB Group |
Primary outcome
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
4 secondary outcomes
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay
Time frame: Day 1
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay compared to Xpert MTB/RIF
Time frame: Day 1
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF
Time frame: Day 1
Time to TB detection and RIF resistance detection.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Results publication: PubMed 23349670Nikam 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.
- Results publication: PubMed 26786489Nikam 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.2014.04.003. Epub 2014 Jun 2.
- Derived from this study: PubMed 40122135Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.
- Derived from this study: PubMed 34049948Penn-Nicholson A, Gomathi SN, Ugarte-Gil C, Meaza A, Lavu E, Patel P, Choudhury B, Rodrigues C, Chadha S, Kazi M, Mace A, Nabeta P, Boehme C, Gangakhedkar RR, Sarin S, Tesfaye E, Gotuzzo E, du Cros P, Tripathy S, Ruhwald M, Singh M, Denkinger CM, Schumacher SG; Truenat Trial Consortium; Members of the Truenat Trial Consortium:. A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays. Eur Respir J. 2021 Nov 4;58(5):2100526. doi: 10.1183/13993003.00526-2021. Print 2021 Oct.
- Derived from this study: PubMed 33616229Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712709, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.