Compliance, Patient Clinical Trial
— DOT-LTBIOfficial title:
A Randomised Controlled Trial of a 12-dose Rifapentine and Isoniazid (RPT+INH) Regimen Using Direct Observed Therapy (DOT) Versus 6 Months of Daily Isoniazid for Latent Tuberculosis Infection (LTBI) in Socially Marginalised People
Verified date | July 2021 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 22 |
Est. completion date | February 9, 2023 |
Est. primary completion date | February 9, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Dept of Pulmonary Medicine | Aarhus | |
Denmark | Dept of Pulmonary Medicine | Esbjerg |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | adherence | adherence to treatment in the two groups measured by counting number of pills taken in each group. | 2 years | |
Secondary | active tuberculosis | 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. | 5 years | |
Secondary | adverse events | for both groups all adverse events will be recorded | 2 years |
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