Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
NCT ID: NCT05073926
Last Updated: 2024-07-15
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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RECRUITING
100 participants
OBSERVATIONAL
2021-09-30
2026-12-31
Brief Summary
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Detailed Description
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The investigators will investigate the risk of acquisition of rifampicin resistance in commensal S.aureus during out-patient treatment for latent tuberculosis using 4 months rifampicin versus 6-9 months isoniazide at Skåne University Hospital in Malmö, Sweden.
Swabs will be obtained from the nose, throat, groin and possible wounds for culture and resistance testing before, during and after cessation of treatment for latent tuberculosis. Whole genome sequencing will be used to analyze accumulation of mutations over time and to determine if it is the primarily detected S.aureus that develop resistance or if the individual is colonized by new, rifampicin-resistant S.aureus over the course of treatment. Household contacts to persons with rifampicin-resistant S.aureus will be examined to investigate onward spread of bacteria within a household.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Persons with latent tuberculosis treated with 4 months rifampicin
Oral rifampicin 10 mg/kg (max 600mg) once daily during 4 months
No intervention is part of the study protocol
No intervention is part of the study protocol. The choice of treatment for latent tuberculosis is is made by the treating physician.
Persons with latent tuberculosis treated with 6-9 months isoniazide
Oral isoniazide 5 mg/kg (max 300mg) once daily in combination with 40mg vitamin B6 (pyridoxin) during 6-9 months
No intervention is part of the study protocol
No intervention is part of the study protocol. The choice of treatment for latent tuberculosis is is made by the treating physician.
Interventions
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No intervention is part of the study protocol
No intervention is part of the study protocol. The choice of treatment for latent tuberculosis is is made by the treating physician.
Eligibility Criteria
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Inclusion Criteria
* prescribed either 4 months rifampicin or 6-9 months isoniazide
* informed consent
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Anton Reepalu
Principal Investigator
Locations
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Skåne University Hospital
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Anton Reepalu, MD PhD
Role: primary
Other Identifiers
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2021-02312
Identifier Type: -
Identifier Source: org_study_id
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