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Evaluation of the performance of a new test for the diagnosis of active tuberculosis.

Performance Evaluation of the VIDAS TB-IGRA on Active tuberculosis study. - NA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026022
Enrollment
984
Registered
2020-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A15-A19- Tuberculosis

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

BIOMERIEUX SA
Lead Sponsor
bioMerieux India Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: A person who meets at least one of the criteria below, classifying him/her as suspected of having M. tuberculosis disease (active TB): - AFB-positive smear microscopy - Positive nucleic acid amplification test (NAAT) for M. tuberculosis - Clinical signs/symptoms - Clinical imagery such as chest X-ray or CT scan compatible with active TB

Exclusion criteria

Exclusion criteria: 1. A person who has been on an anti-TB treatment for more than 15 days for the ongoing infection (for MDR-TB, this refers to the second-line treatment) 2. Pregnant women (self-reported) 3. A person who has received an anti-TNF treatment within the previous 3 months 4. A person who has had a TST in the previous 12 weeks 5. A person who has been diagnosed with a NTM infection 6. A person with positive HIV status, confirmed by a laboratory test or via a rapid test performed at time of inclusion or within one month prior to inclusion into this study

Design outcomes

Primary

MeasureTime frame
Sensitivity and positive percent agreement for the VIDAS TB IGRA assay. Timepoint: After 5 month of recruitment.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

Brazil, France, India, Italy, Mexico, South Africa, United Kingdom, United States of America

Contacts

Public ContactDr Camilla Rodrigues

PD Hinduja Hospital and Medical Research Centre

dr_crodrigues@hindujahospital.com9833324516

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026