Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05724212
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2023-02-02
Brief Title:
Evaluation of a CD4CD8 Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
Sponsor:
Paola Mantegani
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Evaluation of a CD4CD8 Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
IGRAMAT-1
Brief Summary:
Evaluate the possibility of using an IGRA Interferon-γ Release Assay test for monitoring the response to anti-tuberculosis therapy by studying the correlation between the variation in the Interferon-gamma IFN-γ response to the QFT-Plus test in the two tubes containing antigens and the gold standard for monitoring TB therapy culture conversion in patients with slide positiveculture positive and slide negativeculture positive PTB
Evaluate the level of agreement between the results of the new QFT Access test and the results of the QFT plus and culture in patients diagnosed with active tuberculosis To evaluate the level of agreement between QFT Access test results and QFT Plus results in healthy controls and contacts
Evaluate the level of agreement between the results of the new QFT Access test and the results of the QFT plus and culture in patients diagnosed with active tuberculosis To evaluate the level of agreement between QFT Access test results and QFT Plus results in healthy controls and contacts
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None