Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial
NCT ID: NCT05017324
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
248 participants
INTERVENTIONAL
2021-09-21
2025-01-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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WGS DST strategy
WGS DST strategy for diagnosing the TB drug resistance profile and an individualised RR-TB treatment recommendation
WGS DST strategy
WGS DST strategy for diagnosing the TB drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation
Standard of Care
Standard of care diagnosis of the drug resistance profile and individualised treatment
No interventions assigned to this group
Interventions
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WGS DST strategy
WGS DST strategy for diagnosing the TB drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with pulmonary TB (PTB) or PTB plus extra-pulmonary TB (EPTB)
* ≥18 years of age
* Able to sign informed consent
* Not on TB treatment at time of enrolment
Exclusion Criteria
* Patients with TB Meningitis or TB of the bone.
* Has any condition that, in the opinion of the investigator or physician, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives or compromise patient safety.
18 Years
ALL
No
Sponsors
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Aurum Institute
OTHER
University of Stellenbosch
OTHER
University of the Free State
UNKNOWN
Free State Department of Health
UNKNOWN
Universiteit Antwerpen
OTHER
Responsible Party
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Annelies Van Rie
Professor
Principal Investigators
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Gavin Churchyard, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Aurum Institute
Annelies Van Rie, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Rob M Warren, PhD
Role: PRINCIPAL_INVESTIGATOR
Stellenbosch University, MRC
Salome Charalambous, PhD
Role: PRINCIPAL_INVESTIGATOR
Aurum Institute
Locations
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Free State Department of Health Clinics
Bloemfontein, Free State, South Africa
Countries
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Central Contacts
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Facility Contacts
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References
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Van Rie A, De Vos E, Costa E, Verboven L, Ndebele F, Heupink TH, Abrams S; SMARTT team; Fanampe B, Van der Spoel Van Dyk A, Charalambous S, Churchyard G, Warren R. Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment (SMARTT): a study protocol for a phase IV pragmatic randomized controlled patient management strategy trial. Trials. 2022 Oct 8;23(1):864. doi: 10.1186/s13063-022-06793-w.
Other Identifiers
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T001018N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2020-004084-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AUR1-11-248
Identifier Type: -
Identifier Source: org_study_id