Treatment of Latent Tuberculosis in Socially Marginalised Citizens (NCT03266991) | Clinical Trial Compass
TerminatedPhase 4
Treatment of Latent Tuberculosis in Socially Marginalised Citizens
Stopped: Recruitment issues
Denmark22 participantsStarted 2017-10-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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