Treatment of Latent Tuberculosis in Socially Marginalised Citizens

NCT03266991 | Terminated Phase 4 DMC

• 1 other identifier: A101A
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Compliance, Patient

Outcome Measures

Primary Outcomes (1)

• adherence

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

  2 years

Secondary Outcomes (2)

• active tuberculosis

  5 years

• adverse events

  2 years

Study Arms (2)

RPT-INH

EXPERIMENTAL

Participants treated with weekly rifapentine and isoniazid for twelve weeks.

Drug: Rifapentine; Drug: Isoniazid

control

ACTIVE COMPARATOR

Participants treated with daily isoniazid for six months

Drug: Isoniazid

Interventions

Rifapentine DRUG

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

Also known as: isoniazid

RPT-INH

Isoniazid DRUG

Treatment with daily isoniazid in 6 months

RPT-INH; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (2)

Dept of Pulmonary Medicine

Aarhus, 8000, Denmark

Location

Dept of Pulmonary Medicine

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

rifapentine; Isoniazid

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Christian Wejse, MD PHD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD phd-student

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 30, 2017
• Study Start: October 27, 2017
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: October 12, 2023

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)