Treatment of Latent Tuberculosis in Socially Marginalised Citizens
NCT ID: NCT03266991
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
22 participants
INTERVENTIONAL
2017-10-27
2023-02-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RPT-INH
Participants treated with weekly rifapentine and isoniazid for twelve weeks.
Rifapentine
Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
Isoniazid
Treatment with daily isoniazid in 6 months
control
Participants treated with daily isoniazid for six months
Isoniazid
Treatment with daily isoniazid in 6 months
Interventions
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Rifapentine
Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
Isoniazid
Treatment with daily isoniazid in 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Nina Breinholt Stærke
MD phd-student
Principal Investigators
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Christian Wejse, MD PHD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Dept of Pulmonary Medicine
Aarhus, , Denmark
Dept of Pulmonary Medicine
Esbjerg, , Denmark
Countries
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Other Identifiers
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A101A
Identifier Type: -
Identifier Source: org_study_id
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