DOT-LTBI: Treatment of Latent Tuberculosis in Socially Marginalised Citizens

Sponsor
Aarhus University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03266991
Collaborator
(none)
150
2
2
98.2
75
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 27, 2017
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: RPT-INH

Participants treated with weekly rifapentine and isoniazid for twelve weeks.

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

    Active Comparator: control

    Participants treated with daily isoniazid for six months

    Drug: Isoniazid
    Treatment with daily isoniazid in 6 months

    Outcome Measures

    Primary Outcome Measures

    1. adherence [2 years]

      adherence to treatment in the two groups measured by counting number of pills taken in each group.

    Secondary Outcome Measures

    1. active tuberculosis [5 years]

      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.

    2. adverse events [2 years]

      for both groups all adverse events will be recorded

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Pulmonary Medicine Aarhus Denmark 8000
    2 Dept of Pulmonary Medicine Esbjerg Denmark 6700

    Sponsors and Collaborators

    • Aarhus University Hospital

    Investigators

    • Principal Investigator: Christian Wejse, MD PHD, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nina Breinholt Stærke, MD phd-student, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT03266991
    Other Study ID Numbers:
    • A101A
    First Posted:
    Aug 30, 2017
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2021