Tuberculosis
Conditions
Interventions
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be recruited from outpatient TB clinics at district or regional health facilities. They will be intervi
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 partici
Sponsors
Departamento de Ciência e Tecnologia - DECIT. Secretaria de Ciência, Tecnologia e Insumos Estratégicos – SCTIE, Ministério da Saúde-MS (SCTIE/MS)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years or above; Clinical suspicion of pulmonary TB (including cough for at least 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.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) .;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.;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.;Time to TB detection and RIF resistance detection. Assess patient important outcomes, including time to detection of TB and RIF resistance. | — |
Countries
Brazil, Ethiopia, India, Papua New Guinea, Peru
Contacts
Public ContactAfrânio Kritski
Faculdade de Medicina da Universidade Federal do Rio de Janeiro
Outcome results
None listed