NCT03266991

Treatment of Latent Tuberculosis in Socially Marginalised Citizens

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Compliance, Patient

Interventions

Type	Name	Description
DRUG	Rifapentine	Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
DRUG	Isoniazid	Treatment with daily isoniazid in 6 months

Timeline

• Start date: 2017-10-27
• Primary completion: 2023-02-09
• Completion: 2023-02-09
• First posted: 2017-08-30
• Last updated: 2023-10-12

Locations

2 sites across 1 country: Denmark