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

NCT05073926 | Recruiting

• 1 other identifier: 2021-02312
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Latent Tuberculosis; Staphylococcus Aureus

Keywords

rifampicin; isoniazide; staphylococcus aureus; latent tuberculosis; Drug Resistance, Microbial

Outcome Measures

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.

  5 months

Secondary Outcomes (1)

• Frequency of mutations associated with rifampicin resistance in S.aureus during and after rifampicin treatment for latent tuberculosis infection

  10 months

Study Arms (2)

Persons with latent tuberculosis treated with 4 months rifampicin

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

Other: No intervention is part of the study protocol

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

Other: No intervention is part of the study protocol

Interventions

No intervention is part of the study protocol OTHER

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 4 months rifampicin; Persons with latent tuberculosis treated with 6-9 months isoniazide

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital

Malmo, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Latent Tuberculosis; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Central Study Contacts

Anton Reepalu, PhD

CONTACT

+4640337818; anton.reepalu@med.lu.se

Anna Nilsson, PhD

CONTACT

+4640337760; anna.nilsson@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 12, 2021
• Study Start: September 30, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)