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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.