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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03266991
Other study ID # A101A
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date October 27, 2017
Est. completion date February 9, 2023

Study information

Verified date July 2021
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 22
Est. completion date February 9, 2023
Est. primary completion date February 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Dept of Pulmonary Medicine Aarhus
Denmark Dept of Pulmonary Medicine Esbjerg

Sponsors (1)

Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary adherence adherence to treatment in the two groups measured by counting number of pills taken in each group. 2 years
Secondary 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. 5 years
Secondary adverse events for both groups all adverse events will be recorded 2 years
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