Ignite Creation Date:
2025-12-17 @ 2:46 PM
Ignite Modification Date:
2025-12-23 @ 6:58 PM
Study NCT ID:
NCT06485895
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-06-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
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 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A00322-45 | OTHER | N°IDRCB | View |