NCT03712709

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,926

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

September 27, 2018

Last Update Submit

August 4, 2020

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1

Secondary Outcomes (4)

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

    Day 1

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

    Day 1

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

    Day 1

  • Time to TB detection and RIF resistance detection.

    Day 1

Study Arms (2)

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

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

Interventions

Truenat MTBDIAGNOSTIC_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.

Also known as: Truenat MTB Plus, Truenat MTB-RIF Dx
Case Detection GroupDrug Resistant TB Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

EPHI

Addis Ababa, Ethiopia

Location

State TB and Demonstration Center

Ahmedabad, India

Location

NIRT

Chennai, India

Location

PD Hinduja Hospital

Mumbai, India

Location

Related Publications (5)

  • 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.

    PMID: 23349670RESULT

  • Nikam 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.

    PMID: 26786489RESULT

  • Inbaraj 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.

    PMID: 40122135DERIVED

  • Penn-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.

    PMID: 34049948DERIVED

  • Zifodya 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.

    PMID: 33616229DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participant sputum may be retained for future research on TB diagnostics

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 19, 2018

Study Start

March 12, 2019

Primary Completion

July 9, 2020

Study Completion

July 9, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

ET(1)IN(3)