Treatment of Latent Tuberculosis in Socially Marginalised Citizens (DOT-LTBI)

Aarhus University Hospital

Status and phase: Terminated; Phase 4

Conditions: Compliance, Patient

Treatments: Drug: Rifapentine; Drug: Isoniazid

Study type: Interventional

Funder types: Other

Identifiers

NCT03266991

A101A

Details and patient eligibility

About

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 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

RPT-INH

Experimental group

Description:

Participants treated with weekly rifapentine and isoniazid for twelve weeks.

Treatment:

Drug: Isoniazid

Drug: Rifapentine

control

Active Comparator group

Description:

Participants treated with daily isoniazid for six months

Treatment:

Drug: Isoniazid