Treatment of Latent Tuberculosis in Socially Marginalised Citizens

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, randomised controlled trial comparing compliance to treatment for latent tuberculosis infection in socially marginalised citizens. Participants will be randomized to either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed therapy for twelve weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aarhus University Hospital
• Treatments: Isoniazid; Rifampin; Rifapentine

Criteria

Inclusion Criteria:

• Reporting to be homeless (independent of whether the person has an official address) or regularly seeking homeless shelters or public institutions to supply basic needs

• LTBI defined by positive IGRA test

• Found plausible by study doctor that the person has been exposed to tuberculosis within 2 years

• Aged 18 years or older

Exclusion Criteria:

• Previously treated for tuberculosis

• Pregnant or breastfeeding

• Active tuberculosis (evaluated by chest x-ray and examination by a trained doctor)

• Unable to give informed consent

• Tested positive for LTBI as part of contact investigation where the index case has or is suspected to have INH of RIF resistant TB

• Known HIV on antiretroviral treatment

• Porphyria

• Known allergy to rifamycins or isoniazid

• Known epilepsy

• Known liver disease causing affected liver parameters (ALAT, alkaline phosphatase, bilirubin, INR)

• Any lab abnormality, disease, concomitant medication or condition that, in the opinion of the investigator, excludes a person from participating