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

A101A

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.

2017-10-27

2023-02-09

2023-02-09

Terminated

Early phase I

22

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

2023-10-12