Status:
TERMINATED
Treatment of Latent Tuberculosis in Socially Marginalised Citizens
Lead Sponsor:
Aarhus University Hospital
Conditions:
Compliance, Patient
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 isonia...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03266991
Start Date
October 27 2017
End Date
February 9 2023
Last Update
October 12 2023
Active Locations (2)
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1
Dept of Pulmonary Medicine
Aarhus, Denmark, 8000
2
Dept of Pulmonary Medicine
Esbjerg, Denmark, 6700