A comparison of two different treatment regimens for latent tuberculosis in socially marginalised people

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003567-20-DK

Enrollment

150

Registered

2016-11-16

Start date

2017-04-21

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Latent tuberculosis

Interventions

Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Product Name: Priftin Pharmaceutical Form: Tablet INN or Proposed INN: RIFAPENTINE CAS Number: 61379-65-5 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Secondary end points will be adverse events in the two groups and 1-year TB status. All adverse events will be recorded throughout the treatment period in both groups. 1-year TB status will be evaluated by chest x-ray and clinical examination.;Timepoint(s) of evaluation of this end point: adverse events will be evaluated throughout the treatment period. TB status will be evaluated 1 year after treatment completion	—

Measure

Time frame

Secondary end point(s): Secondary end points will be adverse events in the two groups and 1-year TB status. All adverse events will be recorded throughout the treatment period in both groups. 1-year TB status will be evaluated by chest x-ray and clinical examination.;Timepoint(s) of evaluation of this end point: adverse events will be evaluated throughout the treatment period. TB status will be evaluated 1 year after treatment completion

—

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the feasibility of the 12-dose RPT+INH regimen in a real-life setting compared with standard treatment with regards to adhererence;Secondary Objective: Secondary objective will be to collect information on side effects and TB status at one-year follow-up.;Primary end point(s): Primary end point will be adherence to treatment in the DOT group compared with the control group. Completion of the DOT regimen will be defined as 11 doses or more taken within 16 weeks. Completion of the 6 months regimen will be defined as 166 doses or more taken within 35 weeks. In the DOT regimen study personnel will witness all doses taken. In the control group adherence is measured by attendance at monthly dispensing visits, pill count and participants self-reporting of missed doses.;Timepoint(s) of evaluation of this end point: at each visit throughout the treatment period	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the feasibility of the 12-dose RPT+INH regimen in a real-life setting compared with standard treatment with regards to adhererence;Secondary Objective: Secondary objective will be to collect information on side effects and TB status at one-year follow-up.;Primary end point(s): Primary end point will be adherence to treatment in the DOT group compared with the control group. Completion of the DOT regimen will be defined as 11 doses or more taken within 16 weeks. Completion of the 6 months regimen will be defined as 166 doses or more taken within 35 weeks. In the DOT regimen study personnel will witness all doses taken. In the control group adherence is measured by attendance at monthly dispensing visits, pill count and participants self-reporting of missed doses.;Timepoint(s) of evaluation of this end point: at each visit throughout the treatment period

—

Countries

Denmark

Contacts

Public Contactdept of infectious diseases, Aarhus

dept of infectious diseases, Aarhus University Hospital

wejse@skejby.rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026