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Treatment of Latent Tuberculosis in Socially Marginalised Citizens (DOT-LTBI)

Primary Purpose

Compliance, Patient

Status

Terminated

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Rifapentine

Isoniazid

About this trial

This is an interventional treatment trial for Compliance, Patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dept of Pulmonary Medicine
Dept of Pulmonary Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RPT-INH

control

Arm Description

Participants treated with weekly rifapentine and isoniazid for twelve weeks.

Participants treated with daily isoniazid for six months

Outcomes

Primary Outcome Measures

adherence

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

Secondary Outcome Measures

active tuberculosis

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.

adverse events

for both groups all adverse events will be recorded

Full Information

NCT ID

NCT03266991

First Posted

August 11, 2017

Last Updated

October 10, 2023

Sponsor

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03266991

Brief Title

Treatment of Latent Tuberculosis in Socially Marginalised Citizens

Acronym

DOT-LTBI

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Recruitment issues

Study Start Date

October 27, 2017 (Actual)

Primary Completion Date

February 9, 2023 (Actual)

Study Completion Date

February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Compliance, Patient

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RPT-INH

Arm Type

Experimental

Arm Description

Participants treated with weekly rifapentine and isoniazid for twelve weeks.

Arm Title

control

Arm Type

Active Comparator

Arm Description

Participants treated with daily isoniazid for six months

Intervention Type

Drug

Intervention Name(s)

Rifapentine

Other Intervention Name(s)

isoniazid

Intervention Description

Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks

Intervention Type

Drug

Intervention Name(s)

Isoniazid

Intervention Description

Treatment with daily isoniazid in 6 months

Primary Outcome Measure Information:

Title

adherence

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

active tuberculosis

Description

Time Frame

5 years

Title

adverse events

Description

for both groups all adverse events will be recorded

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Wejse, MD PHD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Pulmonary Medicine

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Dept of Pulmonary Medicine

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Latent Tuberculosis in Socially Marginalised Citizens

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