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Video Based Directly Observed Therapy for Latent TB

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ClinicalTrials.gov Identifier: NCT03783728
Recruitment Status : Withdrawn (Investigator is leaving the University)
First Posted : December 21, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Soumya Chatterjee, MD, St. Louis University

Brief 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.

Condition or disease Intervention/treatment
Latent Tuberculosis Drug: Rifapentine 600 mg orally Drug: Isoniazid 900 mg orally Drug: Pyridoxine 50 mg orally

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of Risk-Targeted Video Based Directly on Observed Therapy for Latent TB
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
Untreated Latent Tuberculosis Infection
Isoniazid 900 mg orally + Rifapentine 600 mg orally + Pyridoxine 50 mg orally once a week for 12 weeks
Drug: Rifapentine 600 mg orally
Once a week for 12 weeks using Video Directly Observed Therapy
Other Name: Priftin

Drug: Isoniazid 900 mg orally
Once a week for 12 weeks using Video Directly Observed Therapy
Other Name: INH

Drug: Pyridoxine 50 mg orally
Once a week for 12 weeks using Video Directly Observed Therapy
Other Name: Vitamin B6




Primary Outcome Measures :
  1. Percentage of patients completing treatment [ Time Frame: 4 months ]
    Achieving > 90% treatment completion in patients with LTBI at > 10% cumulative individual risk of developing active TB using vDOT.


Biospecimen Retention:   Samples Without DNA
20 mL of Peripheral Blood Mononuclear Cells (PBMCs) will be collected for future research.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with latent tuberculosis
Criteria

Inclusion Criteria:

- Age 18 years + 1 day (defined as date of birth plus one day). This age cutoff has been selected as tstin3d.com has only been validated for this age group.

Subjects must have all of the following:

  • Untreated Latent Tuberculosis Infection (LTBI), defined as positive Tuberculin skin test/QuantiFERON TB Gold test or T-spot assay done within 1 month prior to enrollment.
  • Absence of active TB disease as determined by history, physical examination, chest X-ray, (sputum smear and/or culture done as needed by the assessing physician for Mtb).
  • Greater than 10% cumulative risk of developing active TB disease (determined by TSTin3D.com).

Exclusion Criteria:

  • A subject will be excluded if any of the following criteria are met:
  • Presence of active TB disease
  • BMI <16
  • Cardiovascular instability (Blood pressure: Systolic >180 or <90 mm/Hg or Diastolic >100 or < 50mm/Hg; pulse <40 or >110)
  • Chest X-Ray report within last 3 months not available
  • HIV positive and currently on treatment with a regimen that has severe drug interactions with 3HP.
  • Presumed infected with INH or Rifapentine (RIF)-resistant M. tuberculosis
  • Women who are pregnant, nursing or expect to become pregnant for the duration of the study.
  • Temperature ≥38.5°C or other clinical evidence of an acute infection at screening
  • History of treatment for >14 consecutive days with a rifamycin or >30 consecutive days with isoniazid during the previous 2 years
  • Documented history of completing adequate treatment for active tuberculosis or latent M. tuberculosis infection in a HIV-seronegative person
  • History of sensitivity/intolerance to isoniazid or rifamycins
  • Serum aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) if AST was determined
  • Hemodynamic instability or medical/psychological condition precluding participation in the study as judged by the investigator
  • No access to a smartphone for personal use
  • Refuse blood draws
  • Refuse to participate in the study
  • If female of childbearing potential and on a hormonal contraception method, refuse to use an additional barrier method with the hormonal method for the duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783728


Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Soumya Chatterjee, MD St. Louis University
Additional Information:
Publications of Results:

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Responsible Party: Soumya Chatterjee, MD, Assistant Professor of Internal Medicine, St. Louis University
ClinicalTrials.gov Identifier: NCT03783728    
Other Study ID Numbers: 29312
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Latent Infection
Pyridoxine
Vitamin B 6
Isoniazid
Rifapentine
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antibiotics, Antitubercular
Leprostatic Agents