MedTrace Logo

Video Based Directly Observed Therapy for Latent TB

NCT03783728 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-07-01

No results posted yet for this study

Summary

Center for Disease Control (CDC) data reveal that after years of sustained decrease, the incidence of active tuberculosis (TB) disease in the US has plateaued. Most of the cases occur when Mycobacterium tuberculosis (Mtb) reactivates replication in people who have latent tuberculosis infection (LTBI). Only 5 to 10% of subjects with LTBI develop active TB Infection over their lifetime. Current US guidelines recommend treating everyone with LTBI to stop progression to active TB. As treatment is long, only about 45-55% of patients finish treatment overall, regardless of whether the patients are at high (\>10%) or low lifetime risk of reactivation. The investigator's study aims to test the efficacy of a combined approach of first determining subjects at high risk of reactivation and then treating them with a CDC approved once a week treatment regimen, directly observed by a nurse over video (video-based Directly Observed Therapy, vDOT). Ensuring treatment of the high-risk group will eventually decrease the community active TB burden.

Conditions

  • Latent Tuberculosis

Interventions

DRUG

Rifapentine 600 mg orally

Once a week for 12 weeks using Video Directly Observed Therapy

DRUG

Isoniazid 900 mg orally

Once a week for 12 weeks using Video Directly Observed Therapy

DRUG

Pyridoxine 50 mg orally

Once a week for 12 weeks using Video Directly Observed Therapy

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Soumya Chatterjee, MD · St. Louis University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-01-31
Completion
2020-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783728 on ClinicalTrials.gov