A comparison of two different treatment regimens for latent tuberculosis in socially marginalised people

Phase 1

• Conditions: atent tuberculosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-003567-20-DK
• Lead Sponsor: Dept of Infectious Diseases, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-16
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the feasibility of the 12-dose RPT+INH regimen in a real-life setting compared with standard treatment with regards to adhererence;Secondary Objective: Secondary objective will be to collect information on side effects and TB status at one-year follow-up.;Primary end point(s): Primary end point will be adherence to treatment in the DOT group compared with the control group. Completion of the DOT regimen will be defined as 11 doses or more taken within 16 weeks. Completion of the 6 months regimen will be defined as 166 doses or more taken within 35 weeks. In the DOT regimen study personnel will witness all doses taken. In the control group adherence is measured by attendance at monthly dispensing visits, pill count and participants self-reporting of missed doses.;Timepoint(s) of evaluation of this end point: at each visit throughout the treatment period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end points will be adverse events in the two groups and 1-year TB status. All adverse events will be recorded throughout the treatment period in both groups. 1-year TB status will be evaluated by chest x-ray and clinical examination.;Timepoint(s) of evaluation of this end point: adverse events will be evaluated throughout the treatment period. <br>TB status will be evaluated 1 year after treatment completion