Treatment of Latent Tuberculosis in Socially Marginalised Citizens

  • End date
    Jan 5, 2026
  • participants needed
  • sponsor
    Aarhus University Hospital
Updated on 5 August 2021


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.


Eligible participants will be randomised to receive either daily isoniazid for 6 months with monthly visits for pill count, evaluation of adverse events and dispensing of isoniazid for the next month, or weekly doses of rifapentine and isoniazid for twelve weeks as direct observed therapy where the drugs are administered in the presence of a study nurse or doctor.

Control bloodsamples (ALAT, alkaline phosphatase, bilirubin, INR, haemoglobin, trombocytes and leukocyte differential count) will be taken at baseline and at least once during treatment in the rifapentine and isoniazid group and at least twice in the isoniazid-only group.

One year after treatment completion participants will be called in for evaluation for active tuberculosis.

Condition Patient Compliance
Treatment isoniazid, Rifapentine
Clinical Study IdentifierNCT03266991
SponsorAarhus University Hospital
Last Modified on5 August 2021


Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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