Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585683
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Post-Trial Tuberculosis Case Finding a Substudy of CoVPN 3008 Ubuntu
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tuberculosis Case Finding At the Completion of the Ubuntu Clinical Trial a Substudy to CoVPN 3008 Ubuntu
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoVPN3008TB
Brief Summary:
This substudy aims to identify cases of tuberculosis after the Ubuntu clinical trial CoVPN 3008 is completed
Detailed Description:
This observational substudy will involve participants from the CoVPN 3008 Ubuntu trial regardless of their HIV status to study tuberculosis TB At the start all participants will be screened for TB even if they have no symptoms They will receive chest x-rays and provide sputum samples for TB testing using Xpert Ultra smear microscopy and culture
The study has two main groups Group 1 includes participants with confirmed TB and Group 2 includes participants without TB who will act as controls
Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples A second follow-up visit will take place at week 26 to evaluate their treatment progress clinical outcomes and TB status ensuring they receive the necessary care
Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls focusing on gene expression linked to TB including hidden subclinical TB
The study has two main groups Group 1 includes participants with confirmed TB and Group 2 includes participants without TB who will act as controls
Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples A second follow-up visit will take place at week 26 to evaluate their treatment progress clinical outcomes and TB status ensuring they receive the necessary care
Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls focusing on gene expression linked to TB including hidden subclinical TB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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