Self-administered Versus Directly Observed Once-Weekly Isoniazid and Rifapentine Treatment of Latent Tuberculosis Infection: A Randomized Trial.

ABSTRACT:

Background

Expanding latent tuberculosis treatment is important to decrease active disease globally. Once-weekly isoniazid and rifapentine for 12 doses is effective but limited by requiring direct observation.

Objective

To compare treatment completion and safety of once-weekly isoniazid and rifapentine by self-administration versus direct observation.

Design

An open-label, phase 4 randomized clinical trial designed as a noninferiority study with a 15% margin. Seventy-five percent or more of study patients were enrolled from the United States for a prespecified subgroup analysis. (ClinicalTrials.gov: NCT01582711).

Setting

Outpatient tuberculosis clinics in the United States, Spain, Hong Kong, and South Africa.

Participants

1002 adults (aged ≥18 years) rec

SUBMITTER: Belknap R 

PROVIDER: S-EPMC5766341 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature