Trials / Recruiting
RecruitingNCT06485895
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Methodology This is a single-center study carried out as part of routine patient care. The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.
Detailed description
It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | test IGRA | BLOOD SAMPLES |
| DIAGNOSTIC_TEST | TEST QUATIFERON TB Gold Plus | BLOOD SAMPLES |
Timeline
- Start date
- 2024-07-30
- Primary completion
- 2027-07-30
- Completion
- 2028-02-01
- First posted
- 2024-07-03
- Last updated
- 2024-08-01
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06485895. Inclusion in this directory is not an endorsement.