Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorRegion Skane
About this trial
Two commonly used treatments for latent tuberculosis infection are either 4 months rifampicin or 6-9 months isoniazid. The invistigators will study the risk of acquisition of rifampicin resistance in commensal Staphylococcus aureus in persons treated with rifampicin versus in persons treated with isoniazide. Through repeated swab cultures before, during, and after treatment the investigators will also investigate potential accumulation of mutations associated with rifampicin resistance over time. Finally, household contacts to persons with rifampicin-resistant S. aureus will be examined to investigate whether onward transmission of rifampicin-resistant S. aureus occurs within households.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with latent tuberculosis
prescribed either 4 months rifampicin or 6-9 months isoniazide
informed consent
Disqualifiers
none
Trial population
Individuals 16 years or older diagnosed with latent tuberculosis and prescribed prophylactic treatment with rifampicin or isoniazide as part of routine care at the out-patient department of the departments for infectious diseases at Skåne University Hospital in Malmö, Helsingborg and Växjö, Sweden.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention is part of the study protocol
Other interventionNo intervention is part of the study protocol. The choice of treatment for latent tuberculosis is is made by the treating physician.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Persons with latent tuberculosis treated with 4 months rifampicin1 intervention
Group B: Persons with latent tuberculosis treated with 6-9 months isoniazide1 intervention
Trial outcomes
Primary outcomes
1
Incidence of rifampicin resistant S. aureus in individuals treated with rifampicin versus isoniazide for latent tuberculosis infection
The proportion of individuals colonized with rifampicin-resistant S.aureus during and after 4 months treatment with rifampicin for latent tuberculosis will be compared with a control group of individuals treated with isoniazide during a similar time period to determine the relative risk of acquiring rifampicin-resistant S.aureus carriage.
Time frame
5 monthsSecondary outcomes
1
Frequency of mutations associated with rifampicin resistance in S.aureus during and after rifampicin treatment for latent tuberculosis infection
The frequency of mutations associated with rifampicin resistance will be determined thorugh whole-genome sequencing at pre-specified time points before, during and after 4 months treatment with rifampicin for latent tubeculosis infection.
Time frame
10 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov