Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis

Region Skane

Status: Enrolling

Conditions: Latent Tuberculosis; Staphylococcus Aureus

Treatments: Other: No intervention is part of the study protocol

Study type: Observational

Funder types: Other

Identifiers

NCT05073926

2021-02312

Details and patient eligibility

About

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.

Full description

The use of rifampicin for treatment of latent tuberculosis has gained popularity due to a shorter treatment course compared with isoniazide (4 versus 6-9 months) since this can lead to a higher proportion of treatment completion. An estimated 25% of the global population is latently infected with tuberculosis. Hence, a shift towards rifampicin instead of isoniazide, which has a more narrow antibacterial spectrum, could have a large impact on the prevalence of rifampicin resistance among commensal bacteria with pathogenic potential, such as Staphylococcus aureus (S.aureus).

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with latent tuberculosis
• prescribed either 4 months rifampicin or 6-9 months isoniazide
• informed consent

Exclusion criteria

• none

Trial design

100 participants in 2 patient groups

Persons with latent tuberculosis treated with 4 months rifampicin

Description:

Oral rifampicin 10 mg/kg (max 600mg) once daily during 4 months

Treatment:

Other: No intervention is part of the study protocol

Persons with latent tuberculosis treated with 6-9 months isoniazide

Description:

Oral isoniazide 5 mg/kg (max 300mg) once daily in combination with 40mg vitamin B6 (pyridoxin) during 6-9 months

Treatment:

Other: No intervention is part of the study protocol