Treatment of Latent Tuberculosis in Socially Marginalised Citizens

Phase 4

Terminated

• Conditions: Compliance, Patient
• Interventions: Drug: Rifapentine; Drug: Isoniazid

• Registration Number: NCT03266991
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Study Start: 2017-10-27
• Status Verified: 2021-07
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RPT-INH	Isoniazid	Participants treated with weekly rifapentine and isoniazid for twelve weeks.
control	Isoniazid	Participants treated with daily isoniazid for six months
RPT-INH	Rifapentine	Participants treated with weekly rifapentine and isoniazid for twelve weeks.

Primary Outcome Measures

Name	Time	Method
adherence	2 years	adherence to treatment in the two groups measured by counting number of pills taken in each group.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept of Pulmonary Medicine; 🇩🇰 Esbjerg, Denmark