Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485895
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TUBIGRA
Brief 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
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 005 degree of precision To take account of non-analyzable samples or tests the investigator will include 500 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00322-45 | OTHER | None | None |