Treatment of Latent Tuberculosis in Socially Marginalised Citizens

Phase 4TerminatedNCT03266991

Aarhus University Hospital22 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Compliance, Patient

Interventions

RifapentineDRUG

Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks

IsoniazidDRUG

Treatment with daily isoniazid in 6 months

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Dept of Pulmonary Medicine

Aarhus, Denmark

Dept of Pulmonary Medicine

Esbjerg, Denmark

Outcomes

Primary Outcomes

adherence

adherence to treatment in the two groups measured by counting number of pills taken in each group.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 5 years

adverse events

for both groups all adverse events will be recorded

Time frame: 2 years

Data from ClinicalTrials.gov

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