NCT03712709CompletedNot Applicable
Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
Foundation for Innovative New Diagnostics, Switzerland4 sites in 2 countries1,926 target enrollmentStarted: March 12, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,926
- Locations
- 4
- Primary Endpoint
- Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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
- Time to TB detection and RIF resistance detection.(Day 1)
- Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF(Day 1)
- 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)
Investigators
Study Sites (4)
Loading locations...
Similar Trials
Completed
Not Applicable
Accuracy and Feasibility of Xpert UltraTuberculosis, PulmonaryNCT03072576Foundation for Innovative New Diagnostics, Switzerland1,400
Withdrawn
Phase 3
Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and LevofloxacinTuberculosis Multi Drug Resistant ActiveNCT02975570Boston University
Completed
Not Applicable
Alternative Diagnoses in Patients About to Start Empiric Tuberculosis TreatmentLung DiseasesTuberculosisNCT06737029Stichting Longartsen voor Afrika311
Completed
Not Applicable
Xpert MTB/XDR Clinical Evaluation TrialTuberculosis, PulmonaryTuberculosis, Multidrug-ResistantNCT03728725Foundation for Innovative New Diagnostics, Switzerland710
Unknown
Not Applicable
Probe Melting Technology for Rapid Detection of Drug Resistant TuberculosisTuberculosis, PulmonaryNCT02776150Beijing Hospital3,100