Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05017324
Status:
RECRUITING
Last Update Posted:
2021-10-15
First Post:
2021-04-22
Brief Title:
Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial
Sponsor:
Universiteit Antwerpen
Organization:
Universiteit Antwerpen
Study Overview
Official Title:
Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial
Status:
RECRUITING
Status Verified Date:
2021-10
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:
SMARTT
Brief Summary:
The primary aim of this pragmatic trial is to determine the effectiveness of a Whole Genome Sequencing WGS Drug Sensitivity Testing DST strategy to guide individualised treatment of rifampicin resistant tuberculosis RR-TB patients
The primary objective is to determine the effectiveness of this WGS DST strategy in patients diagnosed with RR-TB We will additionally perform an exploratory health economics evaluation of both arms and will determine the feasibility of the WGS DST strategy
The primary objective is to determine the effectiveness of this WGS DST strategy in patients diagnosed with RR-TB We will additionally perform an exploratory health economics evaluation of both arms and will determine the feasibility of the WGS DST strategy
Detailed Description:
The trial will be a single blinded randomised controlled pragmatic medical device trial evaluating a Whole Genome Sequencing WGS Drug Sensitivity Testing DST strategy to guide individualised treatment of rifampicin resistant tuberculosis RR-TB patients A total of 248 patients diagnosed with RR-TB in the South African Free State province will by randomised to one of two trial arms 124 patients will be assigned to the intervention arm consisting of a WGS DST strategy for diagnosing drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation 124 patients will be assigned to the control arm where the diagnosis of Mtb drug resistance and individualisation of RR-TB treatment will happen according to the Standard of Care SOC procedures
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 |
|---|---|---|---|
| 2020-004084-10 | EUDRACT_NUMBER | TBM FWO | None |
| T001018N | OTHER_GRANT | None | None |