Clinical trial NCT03712709: Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test
Official title: Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Pulmonary
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Burnet Institute
name: National Institute for Research in Tuberculosis, Chennai, India
name: Universidad Peruana Cayetano Heredia
name: Ethiopian Public Health Institute
name: PD Hinduja Hospital and Medical Research Centre, Mumbai, India
First posted: 2018-10-19
Enrollment: 1926
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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).

Primary outcomes:
measure: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay
timeFrame: Day 1
Secondary outcomes:
measure: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay
timeFrame: Day 1
measure: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay compared to Xpert MTB/RIF
timeFrame: Day 1
measure: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF
timeFrame: Day 1
measure: Time to TB detection and RIF resistance detection.
timeFrame: Day 1
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: EPHI
city: Ahmedabad
country: India
facility: State TB and Demonstration Center
city: Chennai
country: India
facility: NIRT
city: Mumbai
country: India
facility: PD Hinduja Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.