Compliance, Patient
Conditions
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 isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed therapy for twelve weeks.
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, 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.
Interventions
DRUGRifapentine
Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
DRUGIsoniazid
Treatment with daily isoniazid in 6 months
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adherence | 2 years | adherence to treatment in the two groups measured by counting number of pills taken in each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| active tuberculosis | 5 years | active tuberculosis within the study period. In case of suspected tuberculosis during the study the participant will be refered for examination by specialists. At 1 year follow-up participants will have a chest x-ray and physical examination by study doctor to screen for signs of active tuberculosis. If active tuberculosis is suspected further examinations will be performed by specialists. |
| adverse events | 2 years | for both groups all adverse events will be recorded |
Countries
Denmark
Outcome results
None listed