Clinical trial NCT03266991: Treatment of Latent Tuberculosis in Socially Marginalised Citizens
Official title: 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: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Compliance, Patient
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: adherence
timeFrame: 2 years
Secondary outcomes:
measure: active tuberculosis
timeFrame: 5 years
measure: adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept of Pulmonary Medicine
city: Esbjerg
country: Denmark
facility: Dept of Pulmonary Medicine
Study officials:
affiliation: Aarhus University Hospital
name: Christian Wejse, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: