Treatment of Latent Tuberculosis in Socially Marginalised Citizens

  • STATUS
    Recruiting
  • End date
    Jan 5, 2026
  • participants needed
    150
  • sponsor
    Aarhus University Hospital
Updated on 5 August 2021

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.

Details
Condition Patient Compliance
Treatment isoniazid, Rifapentine
Clinical Study IdentifierNCT03266991
SponsorAarhus University Hospital
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note