Treatment of Latent Tuberculosis in Socially Marginalised Citizens

Compliance, Patient Clinical Trial

— DOT-LTBI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03266991
• Other study ID #: A101A
• Status: Terminated
• Phase: Phase 4
• Start date: October 27, 2017
• Est. completion date: February 9, 2023

Study information

• Verified date: July 2021
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Patient
• Latent Tuberculosis
• Tuberculosis

Intervention

Drug:
• Rifapentine
Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
• Isoniazid
Treatment with daily isoniazid in 6 months

Locations

Country	Name	City	State
Denmark	Dept of Pulmonary Medicine	Aarhus
Denmark	Dept of Pulmonary Medicine	Esbjerg

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence	adherence to treatment in the two groups measured by counting number of pills taken in each group.	2 years
Secondary	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.	5 years
Secondary	adverse events	for both groups all adverse events will be recorded	2 years