Treatment of Latent Tuberculosis in Socially Marginalised Citizens
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: February 9, 2023
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
- Drug: Rifapentine
- Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
- Drug: Isoniazid
- Treatment with daily isoniazid in 6 months
Arms, Groups and Cohorts
- Experimental: RPT-INH
- Participants treated with weekly rifapentine and isoniazid for twelve weeks.
- Active Comparator: control
- Participants treated with daily isoniazid for six months
Clinical Trial Outcome Measures
Primary Measures
- adherence
- Time Frame: 2 years
- adherence to treatment in the two groups measured by counting number of pills taken in each group.
Secondary Measures
- active tuberculosis
- Time Frame: 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
- Time Frame: 2 years
- for both groups all adverse events will be recorded
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Aarhus University Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Nina Breinholt Stærke, MD phd-student – Aarhus University Hospital
- Overall Official(s)
- Christian Wejse, MD PHD, Principal Investigator, Aarhus University Hospital
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.